EP3242587A1 - Mobile, am körper tragbare überwachungssysteme - Google Patents

Mobile, am körper tragbare überwachungssysteme

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Publication number
EP3242587A1
EP3242587A1 EP16701198.0A EP16701198A EP3242587A1 EP 3242587 A1 EP3242587 A1 EP 3242587A1 EP 16701198 A EP16701198 A EP 16701198A EP 3242587 A1 EP3242587 A1 EP 3242587A1
Authority
EP
European Patent Office
Prior art keywords
sleep
monitoring
subject
sensor
clock
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP16701198.0A
Other languages
English (en)
French (fr)
Inventor
David Burton
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2015900015A external-priority patent/AU2015900015A0/en
Application filed by Individual filed Critical Individual
Priority to EP21155403.5A priority Critical patent/EP3841967B1/de
Priority to EP23196226.7A priority patent/EP4306041A1/de
Publication of EP3242587A1 publication Critical patent/EP3242587A1/de
Pending legal-status Critical Current

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Classifications

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    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/16—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for measuring intraocular pressure, e.g. tonometers
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    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
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    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
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    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
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    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
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    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/6803—Head-worn items, e.g. helmets, masks, headphones or goggles
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    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
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    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
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    • G—PHYSICS
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    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
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    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
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    • G—PHYSICS
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    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
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    • A61N2005/0626—Monitoring, verifying, controlling systems and methods
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Definitions

  • the application describes a number of subject (consumer/patient) data-acquisition, monitoring and analysis inventions including any of or any combination of:
  • the application presents a number of method and device inventions incorporating or enabling communication interface (including one or more wearable devices, or connectivity options (such as WWW, IP, LAN, WAN, supplementary/companion monitoring/sensing or computing systems, SAAS including Cloud-computing services or NAS, peer to peer connections etc.) with the means of sensing, monitoring, tracking, storing and/or analysing any of or any combination of a subject's physiological parameters, pathological conditions, psychological states, wake, sleep, activity, fitness, health, other sentient states, associated transitions, and/or neurological parameters including option of automatic determination of the prediction, onset or incidence of health
  • the monitored sleep parameter data ( Figure 1 LHS, [1 ]) can be transferred to a secondary wearable device for sleep status display purposes such as a smart watch device (Figure 1 RHS UPPER, [5]), interconnected mobile, clock or other device etc.
  • the monitored sleep parameter data ( Figure 1 LHS, [1 ]) can also be simultaneously transferred to additional communication networks, systems or other interconnectivity options (such as WWW, IP, LAN, WAN, supplementary/companion monitoring/sensing or computing systems, SAAS including Cloud-computing services or NAS, peer to peer connections etc.) in order to enable personalised or remote tracking, reporting or surveillance or an individual sleep and associated outcomes.
  • additional communication networks, systems or other interconnectivity options such as WWW, IP, LAN, WAN, supplementary/companion monitoring/sensing or computing systems, SAAS including Cloud-computing services or NAS, peer to peer connections etc.
  • a first applied forehead monitoring system and a second information indicator (computer based wrist watch system, mobile device, clock, bangle with indicator such as Figure 1 LHS [8] or [10] or Figure 1 RHS [5]), whereby user/patient can track sleep progress during any stage of sleep and also as a means of tracking sleep deprivation or sleep quality (based on prior sleep or wake measures and/or circadian cycle offsets factors).
  • a second information indicator computer based wrist watch system, mobile device, clock, bangle with indicator such as Figure 1 LHS [8] or [10] or Figure 1 RHS [5]
  • the monitored and exchanged parameters can include sleep, health and fitness
  • measures and indicator display capabilities comprising one or more light-detection and applied forehead electrophysiological sleep-parameter(s) (EEG, EOG and EMG) monitoring capability, along with measures or associated indices including (but not limited to) sleep efficiency (SE), wake after sleep onset (WASO);
  • Figure 1 LHS LOWER [2] or Figure 1 RHS UPPER, [1] and [7])
  • Figure 1 LHS LOWER, [2] or Figure 1 RHS UPPER, [1] and [7]) can comprise of an electronic module containing any of or any combination of functions for physiological monitoring, analysis of monitored physiological parameters, storage of monitored physiological parameters, means of information flow interconnectivitv, health measures or health status indications, including sleep/wake information and/or activity information (i.e. movement, motion, steps, activity etc.) and/or other health information,
  • Said "electronic module” (Somfit) incorporating means (i.e. any of or any combination of magnetic, mechanical, and/or interlocking) of being interchanged between a plurality of wearable health or environmental monitoring devices;
  • a compatible forehead applied sensor device i.e. Figure 1 LHS UPPER [2] or Figure 1 LHS LOWER [2]
  • k Additionally in order to enable the same Somfit electronic module device also be used for daytime or wake activity (i.e. user can transfer more expensive electronic module to wrist band holder device this enabling sleep/wake or day/night 24 hours 7 days a week monitoring from a single Somfit module with different wearable devices such as forehead system for sleep and wrist band for daytime fitness or health tracking.
  • the Somfit electronic module can also incorporate display or indicator capabilities so that the module provides users indication of measures or related indices of sleep/wake as well as daytime fitness or general health tracking capabilities.
  • the Somfit electronic module indicator can be monochrome or graphic displays or alpha numeric type.
  • the display can be simple bar-graph or other graphic or numeric indicator types presenting a range of measures of daytime fitness or general health tracking capabilities, including the analysis measures further detailed elsewhere, throughout this document.
  • the Somfit module can incorporate real sleep parameters by way of the forehead applied monitoring of sleep parameters (including any of or any combination of one or more of or combined channels of any of or any combination of EEG, EMG and/or EOG signals) (i.e. Figure 2 [3] and [2] whereby sleep quality or sleep parameters (including those of homeostatic sleep and/or circadian clock factors) as well as fitness or other general health or daytime parameters can be displayed in a single wearable indicator system for 24 hour, 7 day sleep/wake health tracking capabilities.)
  • sleep parameters including any of or any combination of one or more of or combined channels of any of or any combination of EEG, EMG and/or EOG signals
  • sleep quality or sleep parameters including those of homeostatic sleep and/or circadian clock factors
  • fitness or other general health or daytime parameters can be displayed in a single wearable indicator system for 24 hour, 7 day sleep/wake health tracking capabilities.
  • the said Somfit electronic module i.e. Figure 1 RHS UPPER [1 ]
  • wireless or other connectivity capabilities can manually or automatically transfer the Somfit module sleep monitoring parameters from the forehead Somfit monitoring module (i.e. Figure 1 RHS UPPER [1]) to the smartwatch system (i.e. Figure 1 RHS UPPER [5]).
  • a "Forehead applied sensor” incorporating at least one bipolar electrophysiological forehead electrophysiological signal (Figure 4; [8], [9], [10], [11], [12]);
  • a "Forehead applied sensor” comprising of a reusable sensor
  • a "Forehead applied sensor” comprising of a disposable sensor
  • a "Forehead applied sensor” comprising of a sensor with or without a partial or total circumference headband (Figure 4; [13]);
  • a “Forehead applied sensor” which can comprise on one side of a sensor with self- adhesive surface and embedded self-gelled electrophysiological electrodes, whereby these said “electrode” can be exposed with the removal of backing paper;
  • a “Forehead applied sensor” which can comprise on non-electrode side of said
  • forehead applied sensor a means of interfacing (i.e. self-adhesive, press-stud, magnetic, mechanical interlocking or other means) to said "electronic module” or a device containing or holding said “electronic module” ( Figure 4; [7]);
  • a “Forehead applied sensor” can monitor at least one forehead sleep-parameter signal including any of or any combination of EEG, EOG and EMG;
  • Measures or associated indices can include any of or any combination of this for fitness, health and/or sleep-parameters ⁇ personalised sleep quality, efficiency/SE, wake after sleep onset/WASO, deep-sleep body recovery period, REM sleep brain restoration period, sleep-in-progress tracking, sleep-quality progress, sleep- journal, comparative population or personalised sleep function, sleep-debt, sleep- disturbance, respiratory-disturbance, sleep-disturbance causation along with
  • Somfit system with medical therapeutic or diagnostic Internet Of Medical Devices (IOMD) whereby the Somfit can form a biofeedback (closed loop or other control incorporating Somfit measures as part of decision making processes responsible for controlling therapy administration).
  • said therapy control can include sleep therapeutic devices such oral mouth adjustment systems, patient positioning devices or trainers, PAP, NIPPV and other devices.
  • said therapy control can include relaxation or meditation vidual outputs or controls (i.e. massage chair control) or music or room lighting or video or 3D projections etc.).
  • said therapy control can include magnetic or electrical stimulation devices.
  • the Somnisync system incorporates a means of enabling "dynamic data-exchange" of sleep parameters or other health or fitness parameters between two or more wearable devices or associated mobile wireless communication devices or computer systems.
  • This dynamic data-exchange can be via wireless interconnection between two or more wearable devices enabling a means for sleep monitored parameter data and/or associated sleep measures to be automatically displayed on a wearable display device, such as mobile phone ( Figure 1 , LHS, [8]), smart watch ( Figure 1 , RHS, [5]), wrist bangle ( Figure 1 RHS, [8]) or other wearable system;
  • a wearable display device such as mobile phone ( Figure 1 , LHS, [8]), smart watch ( Figure 1 , RHS, [5]), wrist bangle ( Figure 1 RHS, [8]) or other wearable system;
  • This dynamic data-exchange can be via wireless interconnection between two or more wearable devices enabling a means for sleep monitored parameter data and/or associated sleep measures to be automatically displayed on a wearable display device, such as mobile phone ( Figure 1 , LHS, [8]), smart watch ( Figure 1 , RHS, [5]), wrist bangle ( Figure 1 , RHS, [8]) or other wearable system; ee) An electronic monitoring transfer electronic module from (with applied forehead EEG, EOG, EMG monitoring part), for example, to remove forehead applied sensor and device and transfer electronic module to a wearable wrist device wrist augment conventional daytime wrist pedometer or motion-based fitness devices with sleep measures.
  • a wearable display device such as mobile phone ( Figure 1 , LHS, [8]), smart watch ( Figure 1 , RHS, [5]), wrist bangle ( Figure 1 , RHS, [8]) or other wearable system; ee) An electronic monitoring transfer electronic module from (with applied forehead EEG, EOG, EMG monitoring part), for example,
  • wearable or attachable devices can incorporate a means of detecting room or environmental light conditions (i.e. such means include light dependent resistor or other photo-sensors essential for internationally accepted standard sleep indices such as sleep efficiency or sleep after wake onset).
  • the output information of the light sensors can be linked to online and automatic measures applicable to sleep measures such as sleep efficiency, sleep after wake onset, sleep time, REM sleep (during sleep time), deep-sleep (during sleep-time), NON-REM sleep etc.
  • sleep measures such as sleep efficiency, sleep after wake onset, sleep time, REM sleep (during sleep time), deep-sleep (during sleep-time), NON-REM sleep etc.
  • These said light detections sensor derived measures can be displayed as part of another wearable device to provide a subject instantaneous measures or indicators of sleep function and performance.
  • sleep measures can be displayed in conjunction with other fitness (such as
  • accelerometer and/or motion sensor and/or pedometer sensor measures in order to provide a sleep and fitness tracking capability applicable to the said subject via a wearable information indicator device (such as watch or bangle) or other subject wearable or attachable device.
  • a wearable information indicator device such as watch or bangle
  • other subject wearable or attachable device such as watch or bangle
  • the present invention enables distillation of information using an information triage means (i.e. triage means can include an information dissemination process, whereby such a process is in accordance to a predefined (i.e. but not limited to empirical prior data studies, normative or disease/disorder state populations data or studies) or dynamically (i.e. but not limited to determination and/or adaptation and/or adjustment based on preceding monitored or sensed information) computed user access authority and rights covering role, qualifications, security and privacy aspects as well as appropriate user interface and information access or information content complexity levels.
  • Said "information content” can include sleep architecture, including REM sleep and deep-sleep amount, disruptions or arousals.
  • Jhe present invention can automatically compute and advise a subject when they should be having or need additional sleep, the quality of sleep, the improvement recommendations based on ongoing tracking and computation of a subject's ongoing sleep tracking outcomes, as well as these said outcomes comparable to a subject's normal sleep requirements or normative population database comparatives.
  • the present invention incorporates a means of referencing said data bases.
  • the present invention can enable a questionnaire or sleep survey such as a validated sleep-scale or validated drowsiness scale to be deployed in conjunction with self- assessment in order to establish a set of criteria corresponding to a subject's normal, levels or indices (i.e. REM sleep, sleep time, deep-sleep, arousal index, AH respiratory index, RERA index, overall sleep quality, and/or sleep deprived status, enabling a subject or subject's health carer enhanced information access for improved sleep management.
  • a questionnaire or sleep survey such as a validated sleep-scale or validated drowsiness scale to be deployed in conjunction with self- assessment in order to establish a set of criteria corresponding to a subject's normal, levels or indices (i.e. REM sleep, sleep time, deep-sleep, arousal index, AH respiratory index, RERA index, overall sleep quality, and/or sleep deprived status, enabling a subject or subject's health carer enhanced information access for improved sleep management.
  • a further means of comparing such information with current inter-sleep and intra-sleep progress reports or related trends in order to establish recommendations based on these outcomes and recommendations of hints for subject or associated health carer can include reference to a subject's personal model of sleep as established with said personal survey assessments and ongoing calibration of related "criteria" as well as comparison to patient normative data bases.
  • the present invention enables sleep-stage-linked synchronisation of a clock or
  • alarm system or other clock or alarm system to choose the more optimal alarm time for awakening based on user's need to awaken versus sleep cycles of minimal adverse impact during awakening (i.e. avoid awakening during deep-sleep when longer sleep recovery may be evident, if prediction or eventuation of REM sleep stages are close-by that can enable less disruptive awakening without compromising overall sleep or awakening time requirement).
  • headband sensor capable of monitoring brain signals capable continuous monitoring of sleep parameters (EEG, EOG, EMG) and automatic online processing to enable the determination of sleep stages (i.e. REM, non-REM stage 1 , non-REM stage 2, non-REM stage 3 and stage 1 ).
  • the present invention further provides the options of monitoring room light detection
  • the present invention further provides the option to have the single sensor strip
  • LED with LDR embedded reflective oximeter sensor
  • the oximeter sensor can be attached or embedded in the forehead sensor providing plethysmography and oximetry with associated outputs (including any of or any combination of PTT, pulse-wave oscillatory amplitude autonomic markers of obstructive apnoea, pulse wave amplitude, pulse arterial tone).
  • other sensors can include a "drop-down" (i.e. connects to Somfit) airflow sensor (i.e.
  • PVDF thermo-coupler
  • thermistor thermo-coupler
  • nasal cannula etc.
  • said sensor(s) can enable monitoring of sleep disordered breathing including apnoea, hypopnoea, mixed apnoea/hypopnoea.
  • a wearable wrist-based monitoring device incorporating a gyro-meter or positional tracking system capable of inputting to automatic incorporating means of computing gait, walking characteristics (including Parkinson's onset) including automatic analysis of long-term trending of automatic gait analysis capable of detecting fluidity of walking and manoeuyring, along with predictive assessment of associated outcomes (i.e. hint to see GP or specialist based on detected trends that may have further implications) of individual's walking (gait) such as inability to naturally swing arms with walking stride, short or shuffling steps and difficulties (i.e. change of motion of limbs and stride associated with manoeuvring corners).
  • Any combination of measures such as GPS, gyro-meter, motion, location data can be analysed as a marker of predefined events or health condition onset, or incidence (Figure 1 RHS, [5]).
  • watch-body modular sensor platform system incorporating any of or any combination of photo-plethysmography, oximetry plethysmography, temperature, spring- pressure-loaded or fixed sensor electrophysiological monitoring (i.e. conductive rubber), means of galvanic skin resistance (GSR) monitoring, Doppler ultrasound monitoring, light detection
  • GSR galvanic skin resistance
  • said means of GSR can include incorporation of a plurality of non-polarising
  • electrodes applied to skin surface with a small constant current (i.e. 3 to 5uV), whereby electrical resistance of palmar skin is proportional to the voltage potential developed between said electrodes.
  • the resistance is mainly due to the semi-permeable nature of the sweat glands and
  • An option of the present invention's GSR approach includes switching or alternating the direction of the small constant current between the electrodes in order to minimise electrode polarisation effects.
  • Example embodiment of watch-body modular sensor platform system incorporating DOPPLER ULTRASOUND MONTORING and/or TONONOMETER MONITORING detection system is illustrated.
  • Ear-bud (earphones) worn monitoring device with combined sleep, health and fitness
  • - eLifeKIT provides a range of wearable or applied monitoring systems capable of working individually or as part of a cluster of interconnected systems across a common framework and health management system platform, enabling personalised health management system framework, based on a compatible health tracking and management technology;
  • MTM multipoint time-synchronisation monitoring
  • MTM incorporates calibration modes and corresponding compensation modes to minimise online or data reconstruction time-alignment errors across disparate transmission medium or multiple, simultaneous monitoring devices or systems, of a subject at any time or under varying monitoring/ communication conditions.
  • MTM can be deployed across a disparate group of monitoring systems and communication networks with the adoption of free-running, master-slave or multi- modality timing reference approaches, in order to achieve minimal data acquisition misalignment with precision of time-clock synchronisation of more interrelated monitoring systems ranging from atomic-clock accuracy or as required in accordance to accuracy ranging from and reduction of associated phase or data alignment errors applicable to special-purpose or specific applications or requirements.
  • the present eLifeSLEEP invention enables true sleep monitoring and tracking with the incorporation of a head applied (i.e. Somfit) system capable of monitoring principal sleep parameters for the investigation of sleep and sleep related disorders with a single small electronic device easily applied (i.e. magnetically) and disposable self-adhesive (avoids cross infection or need for pressure application to an individual's head or forehead).
  • a head applied i.e. Somfit
  • a single small electronic device easily applied i.e. magnetically
  • disposable self-adhesive avoids cross infection or need for pressure application to an individual's head or forehead.
  • Chest-worn monitoring device with stethoscope sleep and wake breathing sound, central versus obstructive apnoea/hypopnoea and other automatic sleep disorder tracking capabilities (Figure 1 LHS UPPER [7]).
  • Chest-worn monitoring device with combined sleep, health and fitness incorporating a range of physiological parameter monitoring sensors including stethoscope sound monitoring with online automatic breathing disorder determination and tracking, reflective plethysmography oximeter and related outputs, photo-pulse, energy/heat profile characterisation for enhanced calorie burn determination (with option of monitoring spatiotemporal dynamics of body- heat emissions using time-gated NFIR analysis) for enhanced calorie burn determination.
  • the present invention further comprises of obstructive versus central apnoea discrimination by way of correlating respiratory movements with respiratory effort, whereby respiratory effort can be determined by EMG and/or pulse transient oscillatory amplitude measures and/using thoracic and/or abdominal respiration circumference movement) (Figure 1 LHS UPPER [7]).
  • APM adaptive physiological-body monitoring
  • interconnectivity options including simultaneously interconnecting with additional communication networks, systems or other interconnectivity options such as WWW, IP, LAN, WAN,
  • SAAS including Cloud- computing services or NAS, peer to peer connections etc.
  • the and/or communication pathways i.e. wireless connectivity
  • monitoring study type requirements i.e. professional medical level or consumer level study type, format and criteria
  • minimise risk of data loss such as during wireless connectivity degradation or disruption
  • the APM system adopts a substantially enhanced degree of data- acquisition/monitoring/sensing system resource and communications "elasticity" for improved system reliability and data dependability by enabling adaptation of automatic compensation of changing or unpredictable monitoring conditions such as subject's body shrouding of wireless communication pathways, associated with wearable-monitoring devices.
  • eUfeBA I MOBILE DEVICE & INTEGRATED SENSOR ARMBA D
  • An armband-worn m@fabolism » mon1 ⁇ 2 rlng device such as a mobile phone-case with combined health and fitness monitoring capabilities, incorporating a range of sensors particularly useful for determination of an individual's energy exertion associated with estimating or predicting an individual's metabolic rate (calorie burn) related to exercise effort, incorporating measures based on characterisation of the spatiotemporal dynamics of body-heat emissions (i.e. time-gated NFIR analysis) for enhanced calorie burn determination, whereby such means can include any number and combination of temperature sensor physiological sensing or 3-dimensional infrared heat-mapping imaging capabilities.
  • Heat dissipation can be measured using more sophisticated means such as infrared sensor enabling body-heat dispersion and emission characterisation enabling physiological temperature as well as temporal special dynamic heat imaging for more comprehensive and precise modelling of metabolism and associated calorie burn rates (Figure 1 LHS UPPER [9]).
  • a phone-case incorporating metabolism-monitoring capability comprising range of sensors and associated multivariate analysis to automatically compute and indicate online (i.e. via mobile App or wearable device indicator with wireless, dynamic-data exchange or exchangeable electronic module compatibility or interface capabilities.) metabolism or calorie burn measures (Figure 1 LHS UPPER [9]) including spatiotemporal dynamics of body-heat/energy emissions (i.e. time-gated NFIR analysis);
  • the present invention provides the deployment of Doppler-watch tracking (DWT) system comprising of monitoring any of or any combination of a subject's wrist, ankle, arm, and/or other subject limb or body extremity for any of or any combination of the following Doppler and/or ultrasonic vascular or cardiac characteristics, based on periodic or continuous monitoring of any of or any combination of: -Dual channel - radial artery and ulnar artery;
  • WDT Doppler-watch tracking
  • the present invention comprises of the deployment of an attachable/wearable/applanation tonometry (A AT) which can comprise of a watch, bangle or other device incorporating a means of periodic or continuous applanation tonometry (Figure 37) whereby said means applies a pressure sensor capable of measuring and/or characterisation of radial and/or ulnar artery ( Figure 38) or other body artery pulsation characteristics (pulse wave-shape).
  • a AT attachable/wearable/applanation tonometry
  • Figure 37 a means of periodic or continuous applanation tonometry
  • a pressure sensor capable of measuring and/or characterisation of radial and/or ulnar artery ( Figure 38) or other body artery pulsation characteristics (pulse wave-shape).
  • the present invention can further computes the pulse wave analysis (PWA) comprising recording a period (10 seconds for example) of arterial pressure in order to derive the associated ascending aortic pressure wave, from which a number cardiovascular measurements such as central aortic systolic pressure, aortic augmentation index, and the central pulse pressure can be derived, and/or other cardiac functional measures.
  • PWA pulse wave analysis
  • a typical circadian clock could be represented by the following 24-hour cyclic sequence:
  • the circadian clock cycle comprises of the following 3 aspects:
  • a free-running period (referred to as tau or the Greek letter " ⁇ ) with an approximate period of 24 hours;
  • a person's entrainment or adjustment of their circadian clock are when a person suffers unexpected or unanticipated sleep urges resulting from jet-lag or other disruptions of conventional sleep routines.
  • a person's biological clock (circadian clock or rhythm) body has not yet adjusted or synchronised with the local time or current routine sleep/wake cycle this can occur following international travel, across different time zones, or examples such as adjusting during or following to shiftwork, or as a result of late nights during demanding study period or other events;
  • the circadian clock has a profound impact upon metabolism, general well-being and sleep/wake regulation
  • circadian factor plays an important role in sleep quantity; i.e. length is not dependent of on the homeostatic sleep factor, but dependent on whether you sleep in accordance to your own circadian sleep cycle (i.e. the circadian sleep cycle factor is more predominant than sleep homeostasis (sleep-urge) 2 ;
  • an understanding and guidance in terms of the interaction and relationship between an individual's homeostatic and circadian processes can be an important aspect as it is important to remain awake for a significant amount of time in order to achieve high quality sleep, and also to have regular bed and rise times to achieve stable sleep duration (i.e. more time in bed to sleep or more sleep is not necessarily better quality sleep but working with versus against your circadian clock can result in the most efficient and effective use of sleep time) 2 ;
  • sleep urge increases the longer you are awake. Consequently this factor is believed to be of major importance for sleep quality. For example, the longer you remain awake the deeper the following sleep episode will be, as marked by an increase in slow wave EEG activity 2 ;
  • circadian rhythm fulfills an important role in terms of sleep quantity.
  • the duration of sleep is mainly determined by when you go to bed.
  • Method or device whereby a subject can control a system's indications or associated display information (i.e. tap or gesture or touch via capacitive surface detection or touch via resistive surface detection etc.) to toggle of switch between display modes reflective of brain-ba&ed steep arameter markers or associated Indices representative of a subject's monitored sleep status and measures refieotive of other fitness and heeiih monitored measures or
  • the present invention provides a method or device whereby a subject can control a system indications or associated display information to foqgfe of switch between display modes reflective of monitored sleep measures or indices (i.e. brain-signal thiked or EEGsigna! based on any of or any combination of EEG, EOG and/or EMG signal-based sleep parameter measures, as well as health and fitness measures (such as accelerometer or motion-based measures and/or as also further detailed elsewhere in this document including "physiological or psychological monitoring including” and/or " Env ronmen al sensing" as detailed elsewhere in this document and below;
  • monitored sleep measures or indices i.e. brain-signal thiked or EEGsigna! based on any of or any combination of EEG, EOG and/or EMG signal-based sleep parameter measures, as well as health and fitness measures (such as accelerometer or motion-based measures and/or as also further detailed elsewhere in this document including "physiological or psychological monitoring including” and/or " Env ronmen al sensing" as
  • a wearable device such as but not limited to headband (Figure 25 ⁇ 7 ⁇ ) ; universal -bipolar sensor ( Figure 23); oximeter (Figure 22); legband (Figure 24); wristband (Figure 2), ankle-band (Figure 2), armband (Figure 2), earphone(s) ( Figure 14), chest-band ( Figure 5 ⁇ 3 ⁇ ; ⁇ 41; Figure 31), other attachable device or watch) can be used to measure and enable ri! fMIk MS ⁇ JSl l ⁇ l lsa
  • headband Figure 25 ⁇ 7 ⁇
  • oximeter Figure 22
  • legband Figure 24
  • wristband Figure 2
  • ankle-band Figure 2
  • armband Figure 2
  • earphone(s) Figure 14
  • chest-band Figure 5 ⁇ 3 ⁇ ; ⁇ 41; Figure 31
  • other attachable device or watch can be used to measure and enable ri! fMIk MS ⁇ JSl l ⁇ l lsa
  • the subject with a wearable device can automatically or manually exchange data with a data-interface compatible device (i.e. but not limited to wireless subject-applied head EEG, EOG and/or EMG signal-based sleep parameter monitoring system) in a way that enables a subject to automatically track sleep measures, indices and overall sleep gualitv (i.e.
  • sleep-debt including measures such as wake after sleep onset, sleep efficiency, REM sleep amount, deep-sleep amount, sleep architecture fragmentation or normality, along with other optionally and user or health-carer programmable accessible prognostic, diagnostic and subject personal-care management measures enabling sleep-debt, sleep
  • a wearable device such as but not limited to ftea3 ⁇ 43 ⁇ 4an3 ⁇ 4' ( Figure 25; Figure 3; Figure 4), wristband ( Figure 2), kie-bMtid
  • Figure 2 armband
  • Figure 32 armband
  • Figure 33 ®e hone(s ⁇ /earbuds
  • Figure 14 chest- be mi
  • Figure 31 other affacf?a >fe ofe oe or ⁇ afcft
  • information that can be exchanged includes information relating to user/patient coaching (recommendations or guide for improved health or current health status), including indicators capable of f ⁇ oo ?meno3 ⁇ 4ii ⁇ sleep a ⁇ > a.m i!
  • the present invention provides monitoring capabilities capable of any of or any combination of physiological chan is including, but not limited to, EEG/P1 , EEG/P2, EEG/Pz. EOG/L/P7, EOG/R/P8, patient posture or if possible multi-axis combined patient position and patient motion, infra-red breathing detection, microphone sound breathing monitoring, light detection (i.e. light detection resistor), optional t&fieciim oximeter, optional wireless interconnectivity with any of or any combination of sensors required for any of categorisation formats applicable to l
  • the present Invention comprises of p ysiological or environmental monitoring !no!nd!ng a y of or any combination of:
  • Plethysmography Oximetry Pulse transient oscillation amplitude measures; Temperature; Energy- exertion/metabolism-monitoring (EM) as a surrogate calorie-burn measure; Sleep Parameters; Physiological and/or Sleep and/or Wake Markers; Sleep Parameters; Sleep Architecture Measures; Environmental sensing; "dynamically-linked capabilities"; Psychological states;
  • the present invention comprises sensing, monitoring, data-acquisition, signal processing, analysis, storage, and information access including the online automatic characterisation of a subject/individual's physiological, neurological, nervous system, movement system, muscular system, psychological, pathological, states, events of interest and/or health conditions including any of or any combination of the following:
  • Rapid Eye Movement REM
  • Sleep Characteristics Sleep Disorder Classifications; Select Sleep disorders; Dreaming States; HALLUCINATION STATES; Dissociated States; Hypnosis States ; and as further outlined below and elsewhere in this patent application document.
  • the present invention provides em onmentai monitoring or sensing comprising any of or any
  • the subject with a wearable device can automatically or manually exchange data with a data-interface compatible device including a subject's room thermostat (or other communication-compatible device) capable of optimising sleep environmental conditions in accordance to a subject's preferences and/or also automatically based on environmentally monitored and/or subject-specific or biological-synchronisation characterisation (i.e.
  • the subject with a wearable device can automatically or manually exchange data with a data-interface compatible device based on subject-specific or biological-synchronisation characterisation and determination as it relates to another person snoring (for example only) and causing sleep disruption to the user or wearer of the present invention, whereby notification i cludes automatic MWM (i- e - mobile phone messages, alarms, calendar entries, events and/or sleep-trainer system and the like) or other sleep disruption deterrents applicable to recommendations, hints, prognostic or diagnostic supporting data access for health-carers or therapeutic adjustment (i.e. any of or any combination of automatic; biofeedback or manual adaptation, adjustment or reconfiguration) of user or subject wearing invention or other nearby person(s);
  • a wearable device such as but not limited to wristband, ankle-band, armband, earphone(s), chest-band, other attachable device or watch
  • the subject with a wearable device can automatically or manually axchame data with a data-interface can include any network connection and/or available communication mediums, networks or other interconnectivity options (including simultaneously interconnecting with additional communication networks, systems or other interconnectivity options such as WWW, IP, LAN, WAN, supplementary/companion monitoring/sensing or computing systems, SAAS including Cloud-computing services or NAS, peer to peer connections etc.).
  • the present invention comprises of a portable device (i.e. mobile wireless system, wrist band, smart watch, phone, PDA, headband, head-worn apparatus, attachable or pocket device etc.) incorporating means of indicating and/or tracking any of or any combination of a swfe/ecfs s/a p performance/function, sloop parameters, iito&ss or motion parameters, flt ss or motion performance/function, healt parameters and/or health performance/function, the present invention further comprising any of or any combination of:
  • >whereby full disclosure includes means of displaying any of or any combination of primary monitored raw data (i.e. physiological waveform data), secondary monitored data (i.e.
  • tertiary data i.e. analysis transformation(s) of primary or secondary data such as, but not limited to, indices or spectral analysis, signal dynamics analysis (i.e. non-linear dynamic analysis), correlation analysis, coherence analysis, multivariate analysis, FFT and associated outputs, etc.);
  • -a wearable headband device incorporating means of enabling full-disclosure (i.e. raw data such as any of EEG, EMG, and or EOG electrophysiological signal fluctuations, including capability to enable bandwidth of all sleep and other neurological events including HFOs, spikes, spindles, vertex sharp waves, or other events or health conditions covered elsewhere in this document.
  • full-disclosure i.e. raw data such as any of EEG, EMG, and or EOG electrophysiological signal fluctuations, including capability to enable bandwidth of all sleep and other neurological events including HFOs, spikes, spindles, vertex sharp waves, or other events or health conditions covered elsewhere in this document.
  • -"spectra! c mpensation" and "other compensation” can comprise of a spectral transfer characteristics, phase transfer characteristics, signal amplitude, signal distortion, multiple signal superposition, capable of compensating for neural source locations otherwise attenuated by non- obtrusive monitoring constraints (i.e. forehead positions below hair- line such as Fp1 , Fp2, F7, F8 and/or Fz) versus standardised positions such as (but not limited to) EEG locations traditionally utilised for EEG sleep monitoring parameters (i.e. including F4 - M1 ; C4 - M1 ; 02 - M2; with backup monitoring electrodes including F3 - M2; C3 - M2; o1 - M2 sleep monitoring electrode locations).
  • said EEG signal compensation transfer characteristics incorporate a means of emulating the EEG signal characteristics similar to another "designated alternative location" or "traditional location”
  • determination of a "designated alternative location” can comprise of transfer characteristics based on empirical data studies investigating the comparative EEG signal characteristics of different EEG locations during sleep states in order to enable the relationship and associated transfer function required to convert;
  • the EEG signal of a first monitored location can be processed by a transfer function capable of generating (modelling) a data set applicable to the approximate data sat values of a second monito ed EEG location;
  • the present invention enables a means of full disclosure online signal monitoring, sleep stage analysis, ongoing (whereby means includes the capability to access real-time sample by sample or regularly ampled r&aHime monitored information in order to compute measures indicative of continuous, uninterrupted, raw-data, versus only summaries or compressed versions of data, in order to enable diagnostic quality and industry standard (i.e. ASSM and/or R&K scoring
  • said analysis and monitoring capabilities can be updated online or in virtual real-time so that an individual can read a display indicator (including wireless linked to sleep parameter (i.e. EEG, EMG and/ or EOG) monitoring system) at any time during the subject's sleep or associated wake states using a patient worn or mobile or remote computer device or information access system;
  • a display indicator including wireless linked to sleep parameter (i.e. EEG, EMG and/ or EOG) monitoring system
  • the present invention enables a wearable mobile monitoring system comprising of a means of w te a «d'tor aep he&fi monitoring and management, the said means comprising any of or any combination of (but not limited to) descriptions presented elsewhere in this patent application document including a) Forehead applied physiological monitoring sensors, ) Re-usable or disposable sensors, e) Reusable or disposable sensors automatic reload dispenser de ise, d Continuous online sleep parameter (EEG, EOG, EIVIG) monitoring and sleep analysis, a) Wearable monitoring, f Exebangeabte/lnterehangeable part with dynamic data exc ange, g) Infrared resplrology or body beat flux monitor ng, b) Body position and/or position and/or movement, I) movement and/or mo ion,
  • the present invention enables the monitoring of 1 or more forehead applied physiological monitoring sensors with option of deriving a plurality of sleep parameters from any one or more said sensor(s);
  • said "sleep parameters" monitoring includes any of or any combination of EEG, EOG, EMG, and/or ECG;
  • forehead applied electrodes which can comprise of partial or total head, forehead and or face coverage;
  • the present invention provides the option of disposable self-adhesive forehead applied strip with electrode dispenser device capable of automatically discarding old sensor and replacing with new sensor; c) Reusable or disposable sensors aut matic reload disp ns r device
  • the present invention provides the option of disposable self-adhesive forehead applied strip with electrode dispenser device capable of automatically discarding old sensor and replacing with new sensor, whereby said sensor dispensing device is part of packaging system of a pack of new self- adhesive sensors;
  • the present invention provides the option of dis osable self- d e ive forehead applied strip with electrode dispe ser device capable of automatically discarding old sensor and replacing with new sensor, whereby said sensor dispensing device is part of packaging system of a pack of new self-adhesive sensors, and whereby said dispensing device comprises any of or any combination of (but is not limited to) a) enabling replacement of monitoring sensor from forehead monitoring strip, b)
  • forehead sensor strip can be ush loaded unto and then retracted from the said sensor dispenser device as a means (i.e. a spring tensioned dispenser mechanism can push new replacement sensor onto forehead sensor holder device, while used sensor at the same time is peeled off and discarded.
  • the reloaded sensor and forehead sensor can then be ejected with single depression of ejection button /lever in order to access reloaded sensor system.
  • the present invention provides eon lnnons, uninterrupted sleep parameter monitoring
  • the present invention provides continuous EEG monitoring with associated analysis capable of the rf
  • sleep efficiency/SE wake after sleep onset (WASO)
  • respiratory event related arousals/RERA therapeutic event related arousals/TERA
  • apnoea hypopnoea index/AHI sleep disturbance index/SDI
  • respiratory disturbance index/RDI sleep fragmentation, percentage and amount of each sleep stage, total sleep time/TST, sleep hypopnoea, sleep delay syndrome delay factors, residual daytime sleepiness/RDS, arousal index/AI, degree and other sleep measures such as but not limited to sleep disorders or other events of interest (i.e. including but not limited to events of interest "DENIFITION ", as described elsewhere in this document);
  • 3 ⁇ 4gf s determination can comprise of local (micro-processing device or DSP system forming part of monitoring sensor or device) and/or available communication mediums, networks or other interconnectivity options (including simultaneously interconnecting with additional or supplementary communication networks, systems or other interconnectivity options such as WWW, IP, LAN, WAN, supplementary/companion monitoring/sensing or computing systems, SAAS including Cloud-computing services or NAS, peer to peer connections etc.).
  • local micro-processing device or DSP system forming part of monitoring sensor or device
  • networks or other interconnectivity options including simultaneously interconnecting with additional or supplementary communication networks, systems or other interconnectivity options such as WWW, IP, LAN, WAN, supplementary/companion monitoring/sensing or computing systems, SAAS including Cloud-computing services or NAS, peer to peer connections etc.
  • wearable monitoring (including option of mobile wireless interconnected) devices or associated system van comprise of any of or any combination of example monitoring embodiments per Figure 1 to Figure 94
  • the present invention incorporates a
  • the said of connectiviW can include any of or any combinations of connectivity with available communication mediums, networks or other interconnectivity options (including
  • !i!!liiff can include combining, sharing, exchanging indications, displays, data storage, data processing, deriving indices, based on ⁇ g fashionCS2£ l££i. fiS S2l£ll!;i or associated measurement derivations (i.e. such as EEG, EOG, EMG, breathing sound, room or environmental sound, room light conditions, airflow, reflective plethysmography oximetry and associated outputs (pulse wave amplitude/PWA, pulse arterial tone/PAT, Pulse arterial tone/PTT, pulse-wave oscillatory amplitude autonomic markers of obstructive apnoea to enable central versus obstructive discrimination (i.e.
  • the present invention can enable "separate or combined sleep and/or other health and/or fitness measures and/or information" to be indicated or displayed as part of any wearable devices (i.e. wrist device, watch, clock etc.);
  • the present invention can incorporate one or more "attached infrared” breathing monitoring sensor(s) and/or skin heat flux monitoring centre(s) (body energy dissipation via skin surface, enabling measure of energy or calories burning/metabolic-activity of subject);
  • the present invention can comprise of one or more infrared sensors with option of associated lens in a manner whereby the sensor is incorporated as part of a forehead sensor that can be located and the sensor directed to detect a subject's breathing and associated breathing disorders; h tens
  • infrared sensors can be combined with one or more lens systems capable of focussing respiration heat change associated with subject's oral and/or nasal breathing inspiration and expiration towards direction of infrared sensor;
  • the said "infrared sensor” can comprise of thermal sensors including any of or any combination of (but not limited to) photo diode, photo conductive, photovoltaic, pyro-electric types;
  • the said "infrared sensor” can comprise of photonic (photo-detectors) including any of or any combination of (but not limited to) charge coupled device or active pixel sensors (CMOS);
  • CMOS active pixel sensors
  • the present invention can incorporate one or more subject/patient body/position sensors
  • the present invention can incorporate one or more movement and/or motion sensors (i.e. but not limited to one or more axis accelerometers) as detailed elsewhere in sections titled “Position, locational and movement sensing and monitoring”;
  • movement and/or motion sensors i.e. but not limited to one or more axis accelerometers
  • the present invention can incorporate one or more attached photo-plethysmography (PPG) sensor(s), and/or reflective oximeter(s) with the option of plethysmography function, as detailed elsewhere in sections titled "Plethysmography Oximetry and/or photo-plethysmography (PPG)"; k Forehead or, head or body attached t erma airflow s ionltorlsig
  • -wearable sound monitoring i.e. but not limited to forehead or, head or body attached microphone
  • combination of breathing sound i.e. but not limited to microphone
  • other physiological signal i.e. thermal airflow monitoring including, but not limited to infrared sensor capable of tracking airflow temperature changes related to breathing subject/patient
  • thermal airflow monitoring including, but not limited to infrared sensor capable of tracking airflow temperature changes related to breathing subject/patient
  • the present invention combines one or more wearable monitoring systems (i.e. but not limited to head attached or applied device with sound or thermal monitoring sensor(s))) and/or one or more microphone sensors capable of distinguishing of differentiating two or more sound sources in order to detect breathing sounds of one or more wearable monitoring systems (i.e. but not limited to head attached or applied device with sound or thermal monitoring sensor(s))) and/or one or more microphone sensors capable of distinguishing of differentiating two or more sound sources in order to detect breathing sounds of one or more wearable monitoring systems (i.e. but not limited to head attached or applied device with sound or thermal monitoring sensor(s))) and/or one or more microphone sensors capable of distinguishing of differentiating two or more sound sources in order to detect breathing sounds of one or more wearable monitoring systems (i.e. but not limited to head attached or applied device with sound or thermal monitoring sensor(s))) and/or one or more microphone sensors capable of distinguishing of differentiating two or more sound sources in order to detect breathing sounds of one or more wearable monitoring systems (i
  • monitoring breathing sounds i.e. a measure of monitoring any of or any combination of sound, airflow, thermal breathing characteristics related to inspiration and/or expiration and/or aspirating and/or nasal aspirating and/or oral aspirating of a subject/patent/user
  • Such monitoring can incorporate a means of determining one or more sleep/wake states or stages of said subject/patent/user;
  • the present invention provides a wearable forehead sensor (one or more sensors and/or electrophysiological electrodes) strip sleep monitoring system incorporating means of monitoring any of or any combination of sleep parameters (i.e. EEG, EOG, E G), along with any of or any combination of (but not limited to) monitoring, determination and/or tracking of: - sleep disordered breathing monitoring and associated event determination (i.e. microphone and/or thermals respiration determination - i.e. infrared breathing detection), and/or environment light sensing (i.e. light dependent resistor enabling computation of sleep efficiency and other measures),
  • sleep parameters i.e. EEG, EOG, E G
  • - sleep disordered breathing monitoring and associated event determination i.e. microphone and/or thermals respiration determination - i.e. infrared breathing detection
  • environment light sensing i.e. light dependent resistor enabling computation of sleep efficiency and other measures
  • clock refers to daily or weekly schedules according to an individual's social schedule (i.e. "social clock) or work schedule (i.e. work clock) or travel agenda/schedule (travel clock) etc.;
  • circadian clock cycle or offset and other factors with relation to environmental clock, time-zone conditions, and/or other applicable subject/user time factors i.e. via calendar or schedule or itinerary information access to enable determination of social clock, work clock, leisure clock, sleep/wake clock and outcomes including offset with CC along lack or synchronisation or implications of sleep quality risk (i.e. due to asynchronous relationship with CC), sleep urge risk (i.e. result of previous sleep/wake historical information), sleep duration versus sleep quality risk as a result of CC offset factor, etc.);
  • sound envelope analogue signal or digital data processing capabilities i.e. ability to track sound envelope where memory storage and processing requirements are otherwise prohibitive in terms of processing higher bandwidth sound waveform signals, for example, (i.e. as a data reduction mechanism for sleep breathing disorder monitoring whereby sound envelope can be extracted before or after data acquisition, signal processing or memory storage;
  • plethysmography reflective with capability of deriving oximeter outputs including any of or any combination of pulse wave amplitude (PWA), pulse arterial tone (PAT), characterisation of plethysmography amplitude as a means of distinguishing obstructive (i.e. generation of oximeter plethysmography waveform oscillation corresponding to autonomic disruption evident during obstructive sleep apnoea autonomic disturbances),
  • Wearable forehead strip sleep monitoring system incorporating an active circuit element able to be interchanged between wrist mounted monitoring system (i.e. containing motion, position, stride (including interaction with mobile phone motion detection as a measure of stride versus arm motion symmetry and/or synchronicity applicable to movement or neural disorders such as
  • multi-axis accelerometer i.e. whereby any one (i.e. spectral segmentation in accordance to primary energy band of various monitoring goals such as gait/fall/cardioballistogram; stride symmetry or
  • synchronicity between and of subjects extremities or limbs and body) or plurality of single or multi- axis accelerometer sensors can monitor and determine any of or any combination of subject/ patient physiological or movement monitoring including any of or any combination of capable of.
  • cardioballistogram such as via sensing of cardiac pulse variations
  • subject gait or stride characteristics including but not limited to stride symmetry or synchronicity between and of subjects extremities or limbs and body applicable to activity or disorder tracking (i.e. Parkinson's movement disorder);
  • amplification and/or filtering of accelerometer of one or more signals from a single or multi-axis accelerometer (i.e. 3 or more axis but not limited to);
  • amplitude or power analysis designed to characterise characterisation of subject motion, body movements, body vibrations, in terms of signal sources (i.e. in terms of the segmenting movement signals according to motion characterisation along with associated motion source association, such as stride versus arm motion symmetry and/or synchronicity applicable to movement or neural disorders such as Parkinson gait dysfunction; fall-detection; activity versus idiopathic RBD with associated muscle tonicity changes (i.e. REM sleep without atonia); steps; movement; hyperkinesia (exaggeration of unwanted motion), such as twitching or writhing in
  • Huntington's disease or Tourette's Syndrome Huntington's disease or Tourette's Syndrome; tremor, or other movements; diagnosis and treatment of movement disorders, including Parkinsonian Tremor, Restless Legs Syndrome, Dystonia, Wilson's Disease or Huntington's disease; bradykinesia (i.e. slowness of movement) and dyskinesia (i.e.
  • motion and/or patient position analysis techniques including any of or any combination of analysis techniques covered elsewhere in this document including but not limited to "Position, locational and movement sensing and monitoring ", “Movement and locational information ", “Gait or movement tracking and characterisation of events of interest”, covered elsewhere in the "eLifeCHEST/eLifeSCOPE” section of this document, and whereby these analyses can be applied to any of or any combination of sensor outputs (i.e. including a plurality of accelerometer axes);
  • a nub of the present invention's personal health management system is to automatically
  • CC entrainment stimulation applicable to subject/oatient/user based on CC input factors, a range of scenarios , covering sleep quality and length relating to the interrelationship or the manner the said subject works with or against their natural CC:
  • the present invention can provide a number of entrainment scenarios such as the intervention with subject-wearable device or environmental lighting as a means various degrees of advancing or delaying a subject's phase response curve (i.e. a subjects inbuilt circadian curve phase relationship with external clock factors, including social, time-zone, work, work-shift, study requirements etc.) applicable to minimising delayed sleep phase disorder (DSPD) or advanced sleep phase disorder (ASPD) according to a subject's health- care oversight or intervention and/or an individual's personal preferences or requirements and/or occupational hazard and safety considerations;
  • DSPD delayed sleep phase disorder
  • ASD advanced sleep phase disorder
  • the present invention can automatically or via manual assistance activate light intensity and type (i.e. visible blue light with short wavelength, and stronger melatonin suppression affect can be deployed as part of an automatically computed CC entrainment treatment regime, versus longer wavelength light) as well as the timing functions of such light therapy (i.e. light-therapy in the evening can enable CC phase delay, while light therapy in the day can product CC phase advancement);
  • light intensity and type i.e. visible blue light with short wavelength, and stronger melatonin suppression affect
  • the timing functions of such light therapy i.e. light-therapy in the evening can enable CC phase delay, while light therapy in the day can product CC phase advancement
  • the present invention can automatically (or with manual intervention option) control entrainment factors (i.e. lighting timing and/or lux intensity and/or melatonin dosage and administration timing or recommendation), as well as the option of recommending or setting bed-times or alarm clock settings, in accordance to a subject/patient (or healthcare advisor) social, work, travel requirements or environmental factors;
  • control entrainment factors i.e. lighting timing and/or lux intensity and/or melatonin dosage and administration timing or recommendation
  • the present invention can advise/coach and/or automatically adjust said CC entrainment in accordance to subject/patient/user preferences, selections or personalised scenario choices (i.e. more aggressive adjustment over a shorter period of days or more moderate CC adjustment over a longer period of days);
  • the present invention can automatically access a travel agenda and based on any of or any combination of these or other CC and sleep homeostatic factors:
  • the present invention can automatically access or interface travel information relating to one or more travel itineraries as a means of generating optimal travel itineraries in accordance to CC entrainment options or optimal subject/patient/user performance outcomes in terms of subject's peak energy CC levels or a subject's optimal sleep bed-times and/or sleep duration times;
  • the present invention can measure environmental lighting conditions applicable to subject/patient/user (i.e. via wearable device such as watch, mobile device etc.) in order to provide coaching or guidance to treat winter depression or other forms of depression or delayed sleep phase disorder (DSPD), or compensate for offset between CC and environmental (i.e. time zone or solar clock factors or behavioural clock properties (i.e. social clock, work-clock, shift-works, travel/jet-lag clock, clock and associated requirements or planning/scheduling preferences), whereby said coaching can include CC offset therapy (i.e. light therapy, melatonin medication, adaptation of homeostatic sleep factors (i.e. optimal increasing of a
  • CC offset therapy i.e. light therapy, melatonin medication
  • adaptation of homeostatic sleep factors i.e. optimal increasing of a
  • the present invention can automatically incorporate all CC entrainment factors, indication aspects, alarm clock functions, light detection functions, coaching and/or messaging and/or alert functions, into a single application as part of a wearable or mobile device:
  • the present invention can determine circadian clock nadir factors (i.e. body temperature and/or interval from body temperature nadir to sleep offset) including subject/patient/user's with delayed sleep phase syndrome (DSPS) in order to optimise CC entrainment (i.e. light therapy including glasses with blue light projected towards subject/patient/user retina as a stimulus - can be blocked form forward projection based on shaded or blocked upper section of glasses in order to minimise obtrusive or obvious nature of such treatment), whereby light exposure prior to the nadir of the core body temperature rhythm can produce phase delay, whilst light therapy (bright light therapy) administered after nadir can result in advancement of phase;
  • circadian clock nadir factors i.e. body temperature and/or interval from body temperature nadir to sleep offset
  • DSPS delayed sleep phase syndrome
  • the present invention can track sleep-wake rhythms and characterise a lack of clearly discernible circadian patterns of sleep-wake time, as a marker or potential prognosis of irregular sleep-wake rhythm:
  • the present invention can in incorporate sleep-wake rhythms and characterise a lack of clearly discernible circadian patterns of sleep-wake time, and/or questionnaire outcomes relating to excessive sleepiness , unrefreshing sleep, and/or insomnia that vary in accordance to work schedule as a marker or potential prognosis of shift work disorder (SWD) ;
  • SWD shift work disorder
  • a nub of the present invention is to enable the derivation of an individual's (subject/patient/user's) natural inbuilt (endogenous) circadian temperature by way of readfarvautomatse regressive analysis modelling with one or more external Inputs (CRX).
  • CRX external Inputs
  • the said arcadian-automatic regressive analysis modelling can incorporate context analysis:
  • said context analysis (not limited to) in one embodiment example of a model only can include Inputs to the said model comprising of an Individual's Inbuilt circadian rhythm clock Information can include any of or any combination of (but not limited to): ) C rcadian algorithm input; s «rv «y(s) or tracking subject/patient information
  • tracking subject/patient Information such as sleep propensity or sleepiness information such as with Epworth Sleepiness scale or other survey/scales/measures, or routine sleep, wake, work, recreation and/or other active routines, similar data derived from applications such as health apps or calendars, schedulers, health applications, wearable or mobile devices etc.;
  • -local or new time 3 ⁇ 4one Information i.e. but not limited to GSM, GPS, radio clock or other timing source
  • Orcadian algorithm outputs phase shift between inbuilt arcadian clock and local
  • outputs of said context analysis model (not limited to) in one embodiment example of a model only can include any of or any combination of (but not limited to):
  • Orcadian algorithm processing auto-regressson estimation of natural or inbuilt estimation of local or new environment arcadian clock/rhythm
  • Circadian algorithm processing p i s auto-regression estimation/determination of subject wearable or tt ch le temperature sensors/probes whereby a to pass filtering function capable oi emphasising low frequency cyclic changes for derivation of naiurai/inbuill or new environment circadian clock/rhythm status or requirements
  • the automatic regressive analysis can be subject wearable or attachable temperature sensors/probes whereby a low pass filtering function capable of emphasising low frequency cyclic changes (i.e. 24 hour circadian core temperature changes versus external environment or shorter term activity or exercise mainly independent of circadian core temperature changes);
  • the said "external Inputs” can include any of or any combination of (but not limited to):
  • new environmeni or time zone 24 hour cycle - new environment or time 3 ⁇ 4cne 24 hou cycle i.e. based on GSM, GPS, radio clock, mobile phone or watch determination etc.
  • sleep parameter based i.e. any of or any combination of but not limited to EEG, EOG, EMG measures and associated sleep stage or sleep cycle or sleep hypnogram derivations
  • the present invention can further delineate between external temperature with thermistors positioned to detect current environmental temperature (i.e. one or more temperature sensors incorporated as part of any of or any combination of wearable devices/probes (i.e. watch, mobile phone, earbuds, chest-wall monitor, armband monitor, head, body extremity, body-orifice etc.
  • thermistors positioned to detect current environmental temperature (i.e. one or more temperature sensors incorporated as part of any of or any combination of wearable devices/probes (i.e. watch, mobile phone, earbuds, chest-wall monitor, armband monitor, head, body extremity, body-orifice etc.
  • the present invention's CRX analysis can compare and contrast heat-flux measures versus external environment versus core body temperature versus skin temperature measures (i.e. temperature probes just above skin surface can reflect heat flux emitted from skin surface, versus deeper earbud measures being more reflective of body temperature, versus external environment temperature sensors not as closely associated with body temperature changes, for example only).
  • Circadian temperature Orcadian algorithm processing options wearable health monitoring and/or tracking system/device
  • the present invention provides a circadian function within a wearabf® health monitoring and/or tracking system/device, whereby such function includes any of or any combination of:
  • rhythm management demands influencing said "inbuilt" circadian cycle (i.e. EEG, temperature, sleep/wake staging or associated cycles; noise, activity etc.),
  • Orcadian algorithm oaipai providing ,, external , circadian , stimulus
  • ®xi®ma$ st mulus i.e. temperature change of wearable, environmental, bed or bedding material or bed room etc., or light along with associated power and/or colour and/or frequency of lighting
  • the present invention can incorporate one or more ⁇ iiS fif£ l £®Jg2I ! ⁇ LSS ⁇ £t felE, l il3 ⁇ 43 ⁇ 4gff and/or (but not limited to) other physiological measures with option of plethysmography formats as further detailed in eLifeCHEST/eLifeSCOPE chapter under section "Temperature” or eLifeBUDS chapter, and elsewhere in this document describing temperature monitoring and analyses.
  • the present invention incorporates ⁇ ⁇ fi iMS S IStiSS iil SS such as (but not limited to) monitoring and derivation of associated measures relating to the subject/patient's natural including (but not limited to monitoring associated brain regions (i.e.
  • suprachiasmatic nucleus (circadian clock) regions) applicable to circadian EEG cycle signals (such as for determination of circadian clock cycle for subject/patient),
  • the present invention can compute and determine sensitivity and/or filtering and/or other processing formats (including any of or combinations of NLDBTV, STV, SR, ER, clusters of ERs, clusters of SRs, spectral EOI, interconnectivity of any of same - i.e.
  • the present invention incorporates a means of EEG monitoring and ource localisation.
  • the said source localisation comprises of source reconstruction is based on £d ⁇ I SfiSi£ subject/patient studies or general population data as a basis of determining signal source or brain sources of interest.
  • source reconstruction is based on £d ⁇ I SfiSi£ subject/patient studies or general population data as a basis of determining signal source or brain sources of interest.
  • each EEG sensor can be designated a sensitivity (amplification) and spectral (filtering) properties in accordance to EEF forward source reconstructions where the neural origins are known but the head surface electrode signals can be computed (using forward equation modelling).
  • the present invention can provide optimal compensation as it relates to electrode locations designed for subject/patient convenience (i.e. per wearable monitor minimisation formats, (such as in Figure 45 or sensor configurations such as Somfit forehead sensor per Figure 16; Figure 28 ⁇ 4]).
  • the present invention can determine optimal EEG signal processing applicable to sensor monitoring systems specific electrode location (i.e. per Somfit) in order to emulate standardised AASM sleep monitoring manual recommendations (i.e. F4 - M1 ; C4 - M1 ; 02 - M2; with backup monitoring electrodes including F3 - M2; C3 - M2; o1 - M2 versus Somfit Fp1 , Fp2, F7, F8 and/or Fz sleep monitoring electrode locations).
  • standardised AASM sleep monitoring manual recommendations i.e. F4 - M1 ; C4 - M1 ; 02 - M2; with backup monitoring electrodes including F3 - M2; C3 - M2; o1 - M2 versus Somfit Fp1 , Fp2, F7, F8 and/or Fz sleep monitoring electrode locations.
  • the present invention can determine optimal EEG signal processing (i.e. adapting frequency, phase and/or amplitude of sensor signals) applicable to sensor monitoring system's specific electrode location (i.e. per
  • Somfit in order to emulate location of brain regions (i.e. suprachiasmatic nucleus (circadian clock) regions) applicable to circadian EEG cycle signals (such as for determination of circadian clock cycle for subject/patient), and/or consciousness switch region (i.e. thalamus), or other brain regions (i.e. but not limited to Figure 66 source localised regions).
  • brain regions i.e. suprachiasmatic nucleus (circadian clock) regions
  • circadian EEG cycle signals such as for determination of circadian clock cycle for subject/patient
  • consciousness switch region i.e. thalamus
  • other brain regions i.e. but not limited to Figure 66 source localised regions.
  • the present invention provides a means of monitoring and indicating as part of a wearable or mobile wireless system one or more measures relating to a subject's circadian rhythm including the incorporation of a subject's brain or temperature measures, the present invention further comprising any of or any combination of (but not limited to):
  • rhythmic or rhythmic pulses of signals from the circadian clock brain region via 1 or more monitored EEG signals whereby in a first process step the frequency or periodic nature of the circadian brain region (i.e. suprachiasmatic nucleus (circadian clock) regions) applicable to circadian EEG cycle signals such as for determination of circadian clock cycle for subject/patient, and/or consciousness switch region (i.e. thalamus), or other brain regions (i.e. but not limited to Figure 66 source localised regions).
  • circadian brain region i.e. suprachiasmatic nucleus (circadian clock) regions
  • consciousness switch region i.e. thalamus
  • other brain regions i.e. but not limited to Figure 66 source localised regions.
  • the brain region can be monitored, and/or analysed as a means of computing any measure subject's sleep propensity (i.e. sleep deprivation; sleep delay syndrome; sleep recovery recommendations).
  • the present invention further enables a means of analysing the periodic nature of EEG signals evolving from the human brain or body circadian clock, so that only small samples versus continuous or uninterrupted circadian clock output signals need to be monitored, in order to accurately compute or estimate the cyclic or phasic position at any time or over any period of the human body or brain circadian clock (body clock).
  • the present invention can automatically determine, precise! and indicate offsets between an individual's natural circadian cycle, sleep/wake patters and proposed travel, social, work, recreation. Leisure or other proposed schedule.
  • the present invention can incorporate an indication of an individual's offset between their natural circadian cycle versus their proposed travel agenda and scheduled activities/events. For example, if the individual has to attend a business meeting at a certain time in the future, following a bout of travel, the present invention can take into account the time-zone changes, the travel schedule (i.e. automatic linking to travel websites or personally managed flight schedules, or travel agent flight data etc.) and then provide a measure of sleep urge based on a range of assumptions or an individual's data entries or selections or default factors.
  • the travel schedule i.e. automatic linking to travel websites or personally managed flight schedules, or travel agent flight data etc.
  • the present invention can estimate the likely sleep urge of the subject in meaningful terms (i.e. based on no or little sleep between departure and scheduled meeting you are likely to have a sleep propensity similar to 3 hours after your normal sleep-time or saying up to 3AM based on your normal sleep/wake cycle.) (Figure 96 output blocks (41 to ⁇ 01). Similarly the present invention allows more complex scenarios to be computed and presented (i.e.
  • the present invention enables all these functions and capabilities to be incorporated into one or more wearable or mobile devices (i.e. smartwatch, mobile phone, Somfit sleep monitoring headband and/or other covered elsewhere at any section within this patent application document such as (but not limited to) wearable device examples presented in Figure 1
  • wearable or mobile devices i.e. smartwatch, mobile phone, Somfit sleep monitoring headband and/or other covered elsewhere at any section within this patent application document such as (but not limited to) wearable device examples presented in Figure 1
  • CC treatment systems i.e. such as bright light therap
  • glasses or sunglasses i.e. half-shielded glasses, for example only, tinted in upper section of glass lenses only
  • said glasses can include reflective oculography (i.e. per Figure 43) capable of both entrainment light-therapy and/or detection of eye-lid movements and/or opening as a marker of drowsiness in order to enable biofeedback entrainment capabilities in order to adjust for CC cycle offset factors and/or sleep propensity and/or sleep urge factors.
  • the present invention can incorporate a series of blue LEDS or other blue lighting arrangement, which can be controlled automatically via wireless interconnect to provide an individual's selected entrainment treatment regime designed to adjust for circadian phase advancement or delay based on the present inventions computation of the individual's current circadian clock versus social, travel, time- zone and or work or recreation schedule/clock requirements (i.e. per Figure 9611J) ⁇
  • the present invention can automatically link (i.e. wireless or other interconnectivity communication and information access means) to messaging systems (such as mobile phone SMS, emails, calendar, applications and the like) in order to track an l/or comment/health-coach and/or enable sleep scheduling as it relates to an individual's current circadian clock versus social, travel, time-zone and or work or recreation schedule/clock requirements, in terms of optimal performance, energy, sleep-urge, occupational-health sleepiness risks, fatigue implications and other factors an Individual may be Interested In activating (i.e. per Figure 96 ⁇ 71).
  • messaging systems such as mobile phone SMS, emails, calendar, applications and the like
  • One embodiment of the present invention enables Integrated mapping applications (I.e.. geographical or road map) or related Indications or annotation, to Incorporate additional notes or associated Information, relating to various travel scenarios Indicating or
  • CC entrainment suggestions/health-coaching along with projected or estimated sleep propensity factor or sleep quality aspects (i.e. difficulty based on phase relationship of CC's prior wake period and homeostatic sleep patterns. In this way an individual can visually,
  • scheduling/planning applleatlon(s) (Le, geog a ical or road map) an Indications or annotation, with the option of additional notes or associated Information, relating to various travel scenarios Indicating or symbolising (i.e. single sine-wave cycle with normal sleep periods marked versus new environment time-clock with respectively positioned (i.e. equivalent start and end times corresponding to new time zone environment) along with indication of current individuals CC inbuilt, along with various (i.e. different travel itinerary or different schedules for travel, social events, work events, study, etc.) CC phase-lead, CC phase-lag or adjustment/entrainment (i.e.
  • melatonin dosage and dosage timing and/or bright-light dosage and timing of therapy etc. strategies to align these conflicting clock cycles (i.e. inbuilt CC versus working against social-clock (i.e. based on natural CC wake/sleep requirements versus conflicting clock time-cycle requirements) versus attempting to synchronous CC phase-lead or phase-lag factors.
  • conflicting clock cycles i.e. inbuilt CC versus working against social-clock (i.e. based on natural CC wake/sleep requirements versus conflicting clock time-cycle requirements)
  • attempting to synchronous CC phase-lead or phase-lag factors attempting to synchronous CC phase-lead or phase-lag factors.
  • Integrated calendar or planning or scheduling related applications or applications or processes, mobile personal planning applications, wearable devices, etc. associate travel plans with the related health management impact and precautions or countermeasures to optimise an individual sleep-quality, sleep duration, sleep-timing, daytime energy, sleep-propensity, mood and other elements which clearly can be managed and enhanced in terms of information access, understanding and control vie the present Invention's clrcadlan health management system (i.e. per Figure 96 block [3 ⁇ health management system with associated inputs ⁇ 1 ⁇ and[2L adjunct system options ⁇ 3 ⁇ , and outputs ⁇ 4 ⁇ to [101; Figure 974 stage entrainment adaptive monitoring system).
  • the present invention in one embodiment enables watch or clock application to be programmed so that information relating to the CC clock cycle and/or individual's required scheduled clock requirements (i.e. travel-clock, time-zone changes, social-clock, work-clock, leisure-clock, special-event clock) along with strategies or scenarios capable of providing trip programs or sequences designed to minimise the disruption of quality sleep or an individual performance in work, sport, play, leisure etc. can be structured and stored in a library or easily recallable such each or clock display face setups, along with various CC embodiments,
  • information relating to the CC clock cycle and/or individual's required scheduled clock requirements i.e. travel-clock, time-zone changes, social-clock, work-clock, leisure-clock, special-event clock
  • strategies or scenarios capable of providing trip programs or sequences designed to minimise the disruption of quality sleep or an individual performance in work, sport, play, leisure etc.
  • the present invention can automatically link (i.e. wireless or other
  • an Individual time reference i.e. alarm clock, watch, mobile phone clock or other application
  • sleep scheduling track and/or comment/health-eoaeh as it relates to an individual's current circadian clock versus social, travel, time-zone and or work or recreation schedule/clock requirements, in terms of optimal performance, energy, sleep-urge, occupational-health sleepiness risks, fatigue implications and other factors an Individual may be Interested In activating.
  • one said projected or predicted scenario could be based on the assumption that subject/patient continues their sleep patterns or behavlour/guallty (i.e. time of sleep, sleep time , sleep fragmentation, sleep architecture, sleep arousals, sleep disturbance, respiratory disturbance, REM sleep amount and structure, deep sleep amount and structure) unabated, or with various degrees of correction such as ISl i & M21fiI l - e - gradual increase in sleep quality or decrease in sleep deficit), ⁇ £l . ⁇ S ⁇ l fi£LS£ .ft ⁇ JLfi J£fi20 (i- e - £SL£t£LS!ili fiaCS o S l. trf&SlfeS' light-therapy, sleep hygiene or environmental improvements (i.e. reduce external arousals related to audible noise, temperature, humidity, air pollution or other breathing or asthmas antagonists etc.).
  • sleep patterns or behavlour/guallty i.e. time of sleep, sleep time
  • the present invention provides a "means of computing circadian cycles" based on projecting or predicting a sleep-circadian-cycle scenario based on assumption that the subject/patient reduces or compromises their sleep for a period (i.e. period of study or to allow for a special event, travel etc.).
  • Said means can also provide a typical measure of sleepiness or propensity based on comparative circumstances (i.e. you will be at extreme risk of falling asleep within 10 seconds (i.e. period of say 1 second to 30 seconds subject to specific scenario) of shutting eyes and you should not drive, undertake decisions of financially material nature, undertake any task where occupational work risks to yourself or others are relevant etc.
  • the predicted sleep deprivation scenario could be related to other equivalent reaction time or alertness or sleepiness measures such as the predicted equivalent Epworth sleepiness scale outcomes or blood-alcohol readings etc.
  • rhythmic circadian cycles including for example, but not limited to, examining Information of prior monitored e!reacOan p ysiological variables (i.e. temperature, EEG suprachiasmatic brain region, etc.) and also examining such variables along with other factors influencing the shift of the circadian clock cycle (i.e. sleep parameters and associated sleep measures of subject/patient) in order to determine, based on historical or prior changes versus consequential sleep and circadian clock shift measures, i.e. per algorithm subject/patient-specific learning (ASL) system or wearable-device minimisation (WM) system the subject/patient's prior and/or current and/or predicted (with indicated scenarios) and/or training (i.e.
  • ASL algorithm subject/patient-specific learning
  • WM wearable-device minimisation
  • the present invention provides g for@j efr ⁇ and/or gfi feSUSO"
  • said rcadian dock characterising can comprise of monitoring slow changing, or typically 24 hour cycles with typical sleep and wake phases of cycle, of a subject/patient's temperature, EEG associated with circadian clock (i.e. associated or directly implicated with
  • S£ Hf£3 ⁇ 4 S ⁇ SliSiiSI includes (but is not limited to) any of or any combination of:
  • -alarm clock settings mobile phone clock settings, map applications, calendar applications, any scheduling applications, any project management applications, any travel planning applications, wrist watch settings, computing devices, online applications, social media applications, social network applications or other systems applicable to an individual's sleep/wake management;
  • any occupational health management planning applications any health insurance occupational risk and health applications
  • 3D or other glasses lighting systems, curtain control systems, room temperature or environmental control systems, subject glasses with light therapy function (i.e. to enable light therapy for adjustment of sleep delay or sleep quality), sleep/wake coaching, sleep/wake recommendations, sleep/wake alarm clock or subject/patient clock recommendations or hints or other systems applicable to adapting, adjusting therapeutic intervention of an individual's sleep/wake planning or intervention of timing schedules or cycles (including natural circadian clock aspects);
  • the present invention can include a computer system programmed with steps comprising of a decision matrix incorporating adjustable properties relating to natural circadi n clock device or application-linked means associated with
  • the present invention further enables
  • v) map applications In terms of world travel routes or routing as a mean of planning travel routes to optimise adjustment or readjustment of a subject/patient/user's natural (circadian) time clock in order to adapt back to a timing structure capable of reducing or most appropriately recovering sleep deprivation over a defined (i.e. user preference or essential needs) period of time;
  • Clock alert or alarm system i.e. alarm clock setting, mobile phone clock settings, wrist watch settings, application forming part of existing mobile phone, alarm clocks or other devices settings and functionality;
  • timing indicators and/or alarm clock functions and/or calendar planning coaching or hints and/or messaging system coaching or hints in accordance to optimising schedules or adaptation/adjustment (i.e. recovery from or avoidance oi more adverse sieep deprivation, for example) of personal circadian rhythm in accordance to mild, moderate, significant or severe realignment to optlmai sleep wake cycle (i.e. whereby user can configure their optimal sleep/wake cycle for the immediate sleep/wake periods or any future period, and thereby enabling adjustment from sleep deprivation or unconventional (i.e. departure from standard sleep/wake cycle times due to travel, recreation activities, work demands, exam studies, jet-lag, night-shirt etc.);
  • health or sleep coaching application capable of advising, adjusting or controlling a range of devices or systems (i.e. internet of things or medical internet of things or other wire, wireless means of interconnecting systems) subject/patient/user different options or programs of clock and timing schedules (i.e. via calendar appointments and alarm clock awakenings, along with option of adjusting room temperature, room lighting or associated lighting adjustments and other sleep/wake environmental influences);
  • devices or systems i.e. internet of things or medical internet of things or other wire, wireless means of interconnecting systems
  • clock and timing schedules i.e. via calendar appointments and alarm clock awakenings, along with option of adjusting room temperature, room lighting or associated lighting adjustments and other sleep/wake environmental influences
  • the present invention provides capability of forward e uation sou ce analysis based on the know
  • ifiSIfiSfil sucn as the suprachiasmatic region (circadian clock) and/or associated control or interconnectivity regions of the brain (i.e. as well as options for (but not limited to locations outlined in Figure 66, Talairach Atlas: Current atlas tools; Harvard Whole Brain Atlas, MNI
  • the present invention can provide compensation for electrode location based on
  • the present invention can:
  • a third ste determines the likely attenuation, spectral filtering characteristics, and phase shifts most probable (i.e. based on skin, skull, brain matter attenuation factors applicable between each electrode and the brain region of interest);
  • a subject's sleep/wake behaviour modification recommendations in terms of, for example, adjusting sleep cycle to compensate or minimise time phase sift between a subject/patient's current natural circadian clock cycle and a subject/patient's desired sleep/wake phasic requirements (i.e. adjusting for jet-lag, night-shift, late study or recreational nights and the like);
  • interlinking wireless communication, for example
  • other devices applicable to adjusting or compensating or indicating ((i.e. displaying, comparing or contrasting between circadian phase and cyclic nature versus an individual's required or desired sleep/wake cycle) an individual's sleep cycle and or circadian cycle and such as, but not limited to light therapy (i.e.
  • the present invention provides a means of administering, coaching or medication determination, along with online automatic or assisted (including regulatory, security, privacy and personal authorisation and access requirements) medication ordering based on any of or any combination of (but not limited to):
  • any of sleep/wake monitoring outcomes subject/patient medical information, subject/patient personalised circadian rhythm, subject/patient sleep/wake monitoring outcomes, subject/patient HMS outcomes or related information, subject/patient health survey and other health information records, subject/patient natural circadian versus ongoing sleep/wake schedule requirements, subject/patient circadian monitoring outcomes (i.e. natural circadian rhythm based on EEG circadian clock, temperature and other circadian physiological monitored measures and associated analysis or derived outcomes);
  • dosage and medication or medication-dispenser or medication-coaching i.e. guidance on pharmaceutical such as recommended dosage and dosage schedule automatically programmed and/or control linked with an automated medication dispenser system (i.e. programmed to best compensate shifts between natural circadian rhythm/clock and new environment (i.e. change in time-zone or day-night activities) or sleep/wake/work requirements) ;
  • clock or alarm system i.e. smart watch, alarm clock or mobile phone application that can enable user to select between optimal circadian rhythm synchronised time indication (i.e. for most natural alarm setting or calendar scheduling etc.) versus actual world time-zone based clock, alarm or scheduling means).
  • the present invention provides a means (i.e. means including integrating into a smart watch device any measures or combination of measures including but not limited to temperature sensing of subject, galvanic skin resistance of subject, photo-plethysmography, ECG, oximetry or
  • plethysmography oximetry measures all of which have a very slow underlying circadian cycle component which can be derived using any such measures, with further option of incorporating other wearable or mobile wireless monitoring systems local/distributed analyses outlined elsewhere in this document) of monitoring, computing and tracking, indicating a subject's/patient's circadian rhythm.
  • Such means can also include a means to display any of or any combination of conventional 24 hour time clock and/or date/and or calendar and/or sleep schedule means (i.e. such means can include calendar, messaging, clock display, or other means of indicating any of or any combination of actual subject/patient's actual circadian cycle, one or more predicted or projected circadian cycles, inclusion of the indication of normal variance or the range of sleep deficit and/or surplus that can be accommodated without mild, moderate or severe consequences (moreover this information can be based on comparative population data bases or aggregated subject/patient-specific monitored or other input information (i.e.
  • the said "health conditions of interest” can include (for example but not limited to) sleep disorders this can refer to the American Academy of Sleep Medicine rules for staging sleep scoring sleep-related respiratory disorders ⁇ Le, per section eUfeCHEST/elifeSCQPE section titled " Monitoring, Determination and Tracking of Sleep, Wake and other Mental States, Events of Interest or Health Conditions of Interest"), epilepsy prognosis or diagnosis including detection of events or clusters of events such as HFOs, ripples, spikes, waves, K-complexes or spindles as further details in Figure 751291 Automatic ana es mode Determination.
  • sleep disorders this can refer to the American Academy of Sleep Medicine rules for staging sleep scoring sleep-related respiratory disorders ⁇ Le, per section eUfeCHEST/elifeSCQPE section titled " Monitoring, Determination and Tracking of Sleep, Wake and other Mental States, Events of Interest or Health Conditions of Interest"
  • epilepsy prognosis or diagnosis including detection of events or clusters of events such as HFOs, ripples, spike
  • the said "health conditions of interest” can include (for example but not limited to) the diagnosis or prognosis of Parkinson's, whereby the determination of the said "health conditions of interest” can include (for example but not limited to) monitoring and analysis identification of biomarkers and related "expert system rules" (i.e. per Figure 77 [DT) associated with analysis of events of interest (i.e. symptoms corresponding to diagnosis or prognosis or disorders, health conditions or diseases of interest).
  • expert system rules are described elsewhere, including sleep behaviour disorder combined with movement (i.e. motion or activity characteristics) as further covered under prognostic and/or diagnostic movement disorder marker monitoring and analysis associated with Parkinson's or other movement, muscle or nervous system disorders markers (i.e.
  • rhythmic offset factors Le ⁇ but not limited to section headed Somflt "INVENTION DECRI PTION” Including ⁇ but not limited to) section titled "CIRCADIAN TEM PERATU RE CYCLE DETERM I NATION VERSUS LOCAL ENVI RONM ENT AND/OR
  • the said "health conditions of interest” can include (for example but not limited to) the diagnosis or prognosis of other neural disorders such as ASD as further described in section headed "PATENT TITLE: DIM ENTIA /ALZHEIM ER'S /ASD /ASP" along with associated “IINVENTION DESCRIPTION” section as well as combined measures covered in section headed “eLifeALERT” and associated “INVENTION DESCRIPTION”.
  • the said "health conditions of interest” can include (for example but not limited to) the diagnosis or prognosis of other neural disorders such as ASD as further described in section headed “eLifeALERT” along with associated “IINVENTION DESCRIPTION” section.
  • concordance analysis i.e. means of assessing and rating the accuracy of the expert or artificial system analysis accuracy, compared to comparative expert analysis outcomes in order to both quality control and also continually improve the present invention's prognostic and diagnostic analysis outcomes in terms of validation with professional medical or scientific experts at all times and ultimately provide the highest quality medical and health tracking for subject/user
  • concordance analysis can be automatically deployed in order to validate and where required continually modify and improve the interpreter rules Figure 77 [D] to enhance the accuracy of the Knowledge Base [A] and ultimately the quality of the subject/patient's diagnosis or prognosis Figure 78 [21; [51.
  • the present invention can incorporate minimisation rules as part of the system's artificial intelligence or expert system self-learning capability so that based on the broad-scoped or narrow- scope monitoring criteria or monitoring goals the present invention can both continually validate and improve the monitoring algorithms personalised or specific to the subject/patient as well as streamline and adapt the most appropriate and minimalized wearable monitoring sensors and associated prognostic and diagnostic analyses, once again tailored specific to the
  • the said artificial analysis or expert system analysis self-learning capabilities can be part of one or more mobile and/or wearable monitoring system or supplemented by
  • SAAS software network or associated services or resources
  • SAAS including Cloud- computing services , LAN, WAN, peer to peer, WWW, NAS etc.
  • Figure 78 inputs from experts (including diagnostic review or expert oversight observations per Figure 78 blocks [1]), patient survey or monitoring data [2], can be examined within prognostic Figure 78 [2] or diagnostic Figure 78 [5] modules, for example, in the context of artificial intelligence or expert analysis (as outlined in Figure 77 as described above.
  • experts including diagnostic review or expert oversight observations per Figure 78 blocks [1]
  • patient survey or monitoring data [2] can be examined within prognostic Figure 78 [2] or diagnostic Figure 78 [5] modules, for example, in the context of artificial intelligence or expert analysis (as outlined in Figure 77 as described above.
  • conventional clock face time keeping can be supplemented with a series of circadian clock overlays indicating subject/patient's actual circadian cycle status and/or one or more projected circadian sleep cycle scenarios and/or interlinking with local smart watch and/or interlinking with a remote (i.e. wireless or mobile wireless linked alarm clock application designed to enable recommended sleep alarm recommendations for minimal to maximal sleep quality and/or minimal to maximal work scheduling and/or any compromise or balanced position.
  • a remote (i.e. wireless or mobile wireless linked alarm clock application designed to enable recommended sleep alarm recommendations for minimal to maximal sleep quality and/or minimal to maximal work scheduling and/or any compromise or balanced position.
  • one or more subject/ patient's room or house lights and/or wireless linked lights can be controlled in the context of light therapy to help adjust or optimise a subject/patent's circadian cycle.
  • the present invention enables current or new environment (i.e. world cock time zone) time, along w th current sleep/wake (and option of comparison with work and/or recreation time cycles - i.e. via calendar and/or clock settings of subject/patient/user's mobile device and/or sleep/wake monitoring) as well comparison and contrasting analysis with normal rhythm or typical cycle or phasic nature of subject/patient/user individual during healthy or peak sleep performance or health condition (i.e. via ESS or other sleep propensity or sleep scale performance, sleep/wake studies, sleep study outcomes indicating normal or healthy sleep propensity or daytime performance of an individual);
  • Indicator means such as watch face (i.e. shows clock time of body versus actual clock and/or phase lag or gain and/or recommendation or coaching go catch up with sleep or potential amount to sacrifice sleep without excessive adverse consequences (i.e. modest or minor sleep
  • the present invention can incorporate into a triaged health-watch, or scheduling
  • rhythm/calendar application or shared social or business media information to enable on a personal or community/group level explicit health data or coaching and/or associated treatment (i.e. light therapy circadian clock adjustment entrainment linked to internet of thins or various lights and other associated controls) in order to assist with the management of crucial sleep stages such as deep-sleep (body recovery) or REM sleep (brain restoration), circadian clock alignment (i.e.
  • a mobile wireless personalised mobile device or wearable devices can incorporate a watch function with ability of user to toggle through related watch-face or scheduling modes applicable to any of or any combination of homeostatic sleep/wake stages/stages' local versus travel clocks, work schedules, leisure schedules, relaxation schedules, of a subject and conflicting or other social or business or travel agendas/itineraries.
  • the present invention can coach, guide and recommend calendar entries, activity scheduling, clock alerts or alarms, shift-work schedules or sleep/wake-planning in accordance to the personalised preference of work- productivity and/or focus/attention (i.e.
  • personalised occupational work hazard and risk factors i.e. incorporates a means of monitoring, analysing, correlating and alerting of health conditions such as excessive sleep/wake disruptions including crucial aspects of quality sleep such as amount of REM sleep, amount of deep-sleep, and also the circadian-clock offset factors versus (for example only) population normative requirements along with personalised requirements etc. versus also the level or risk or responsibility of job -i.e. truck driving with indications of snoring or OSA sleep disruptions could be indicated on a personalised and personal safety management level to allow private information but potentially critical personal health guidance and support) and cognitive performance (i.e.
  • the present invention enables a means of self-assessment of a subject/patient via sleep or other health surveys (i.e. but not limited to , ⁇ £S2£lfi dealt S ⁇ fi! i ⁇ court iSg g), whereby sleep urge or sleep propensity can be tracked in accordance to sleep patterns of an individual in order to determine (i.e. artificial intelligence or expert system means per examples Figure 77, Figure 78, Figure 79, but not limited to) sleep patterns and/or sleep start and end times most conducive to minimising sleep urge day-time sleepiness; the present invention can further associate these measures with monitored sleep measures along with associated sleep scoring (scoring of human sleep via sleep stage analysis) and/or respiratory scoring (i.e. detection of sleep disordered breathing) in order to determine, indicate, therapeutic device control (i.e. biofeedback or configuration or pressure dynamics of pressure ranges or dynamical changes of pressure associated with
  • APAP/CPAP/PAP/NIPPV in order to minimise sleep disruptions or sleep fragmentation, maximise sleep architecture quality and/or minimise sleep disordered breathing while talking into account improved sleep propensity or daytime sleepiness (or residual daytime sleepiness). This can involve
  • EEG signals indicative of the brains circadian clock and/or activity or motion of subject/patient and/or homeostatic sleep monitored characteristics and/or sleep/wake or other health survey information
  • the present invention enables wearable mobMe wireless monitoring of information and derivation of whereby such measures can be based on measurement sensors attached or forming part of smart watch, wristband, forehead sensor, armband or other wearable monitoring sensor system incorporating measures that can be analysed in a manner where slow (typically 24 hour slow changing cyclic measures can be derived based on monitoring temperature and/or galvanic skin resistance, and/or heat-flux, and photo- plethysmographic (PPG) measures such as pulse rate, and/or heart rate variability etc., which are physiologically aligned with the natural 24 hour circadian clock function.
  • slow typically 24 hour slow changing cyclic measures can be derived based on monitoring temperature and/or galvanic skin resistance, and/or heat-flux
  • PPG photo- plethysmographic
  • the present invention can monitor and compute a measure of reskl a ⁇ excessive sleepiness (RES) in addition to computation of, comparing, and contrasting measure(s) of any of or any combination of the following as a means of determining association or causation of RES (i.e. TERA versus other factors as a mechanism to optimise automatic positive airway pressure titration in order to maximise obliteration of sleep disordered breathing, optimise cardiac function and optimise sleep quality) with CC or homeostatic factors (i.e. sleep propensity versus circadian clock (CC) asynchronous factors - i.e. delay or advanced CC phase): 1 ) a subject/patient's sleep parameters (i.e.
  • RES reskl a ⁇ excessive sleepiness
  • EEG EEG
  • EMG EMG
  • EOG sleep breathing disorders
  • TERA therapeutic event related arousals
  • RERA respiratory event related arousals
  • arousals arousals
  • circadian clock factors 6) previous sleep duration(s), 7) previous wake period, 8) previous waking periods, 9) previous sleep periods in terms of sleep architecture, 10) previous sleep periods in terms of deep sleep (i.e. N3) and/or REM sleep, 1 1 ) previous sleep period versus CC, 12) current sleep duration(s), 13) current wake period, 14) current waking periods, 15) current sleep periods in terms of sleep architecture, 16) current sleep periods in terms of deep sleep (i.e. N3) and/or REM sleep, 17) current sleep in terms of sleep architecture; 6
  • inbuilt (self-contained) training system capable of detecting snoring (i.e. via inbuilt breathing sound or snoring monitoring function (i.e. accelerometer vibration or microphone sensor) in a manner whereby subject/patient can be alerted or awoken (including headband attached vibration or sound alarm device) based on determination of any of or any combination of:
  • sleep alarm setting i.e. watch, mobile phone, alarm clock etc.
  • sleep stage determination including wake, N1 , N2.
  • subject/patient biological synchronisation with breathing cycle (such as derived from any of monitoring sensors including infrared heat flux or subject/patient breathing signals, in order to mitigate against risk of detection of sleep partner breathing measures (or snoring) versus actual subject/patient snoring measures;
  • the present invention can (for example only):
  • a first acess si® determine from the users selection of alarm request the amount of time before the alarm activates
  • a subject/patient sets alarm for a daytime 1 hour power nap to try and overcome jet-lag or other forms of sleep-urge or sleep propensity, and the present invention determines or tracks (via online sleep analysis capability) that the user/subject is in REM sleep (less adverse recovery impact than N3 deep-sleep state, for example) then the alarm will sound at the selected alarm setting,
  • the present invention determines or tracks (via online sleep analysis capability) that the user/subject appears to be transitioning from REM to
  • Nl/deep-sleep stage (prone to result in high adverse recovery impact than REM stage, for example) and also there is only say 10 minutes time before the alarm set time is activated, along with the condition that the 3 ⁇ 43 ⁇ 4S3 ⁇ 4 : g il Sg is set (or defaulted) to greater than 10 minutes, then the present invention will sound the alarm and allow subject/patient to be awakened in the preferred REM state versus the potential N3 deep-sleep state.
  • the I S ySLS ® ⁇ .SlSff ll !2 . f is the setting related to the maximum time allowed before awakening that the present invention can use its processing capabilities to optimise awakening event based on subject/patient sleep stage.
  • Maximum pte-wak® aiarm time can be set in accordance to sleep time (i.e. hours and minutes) or selected in terms of sleep time (i.e. percentage of total sleep time, where tvmoai start and d SiSS&MnS ⁇ or iJS Si iSMl f lIfiJfiS&£££ ! ⁇ are entered or set as default by system) or time prior to alarm 10% of total sleep period, for example.
  • sleep time i.e. hours and minutes
  • selected in terms of sleep time i.e. percentage of total sleep time, where tvmoai start and d SiSS&MnS ⁇ or iJS Si iSMl f lIfiJfiS&£££ ! ⁇ are entered or set as default by system
  • time prior to alarm 10% of total sleep period for example.
  • the present invention includes (in one example embodiment) the capability for a smart watch with attachable or integrated (embedded or on-board as part of smart watch and/or wireless interconnected processing system(s)) a biofeedback feedback drug delivery (BFDD) system and or "associated therapy” system, whereby said biofeedback drug system can comprise of any of or any combination of: a) a drug delivery dispenser system, b) an automatic analysis system and/or c) a drug delivery control system;
  • BFDD biofeedback feedback drug delivery
  • the said "drug delivery dispenser system” can comprise of any attachable drug delivery system including a manually or automatically controlled drug dispenser capable of "optimal medication dispensation” including any of or any combination of:
  • sleep delay syndrome I.e. Offset between a subject's sleep/wake cycle and/or work cycle/schedule/clock/calendar (i.e. shift work) and/or social cycle/schedule/clock/calendar and/or travel cycle/schedule/clock/calendar (i.e. itinerary)
  • sleep delay syndrome I.e. Offset between a subject's sleep/wake cycle and/or work cycle/schedule/clock/calendar (i.e. shift work) and/or social cycle/schedule/clock/calendar and/or travel cycle/schedule/clock/calendar (i.e. itinerary)
  • said "optimal medication dispensation" can be applicable to any physiological and/or neurological and/or sleep disorder and/or other adverse health condition
  • biofeedback system and/or “associated therapy” system can include any of or any combination of:
  • circadian rhythm entrainment system including light radiation control or light radiation
  • circadian rhythm entrainment system including light radiation control or light radiation
  • the said "automatic analysis system” can comprise of determination of a subjects sleep/eke patterns and/or homeostatic sleep characterisation and/or determination of an individual's circadian clock cycle of an individual as outlined elsewhere in this document;
  • the said "drug delivery control system” can comprise of a drug dispensing mechanism (including, but not limited to, a cartridge loaded drug dispenser which can dispense
  • medication/drugs in order to minimise sleep delay or sleep offset syndrome in a manner which can be configured to be moderate, severe, or other graduated entrainment (I.e. Compensating for an individual's sleep delay or circadian clock offset factor);
  • biofeedback feedback drug delivery system can be a part of any of or any combination of: a) any wireless mobile system; b) any wearable monitoring system; c) any telemedicine system;
  • the present invention provides a mobile wireless phone or wearable device or separate mobile device PLUS option for automatic or manual medication dispenser system (i.e. sleep suppression or antagonist medications such as melatonin etc.) PLUS option for sleep/wake cycle analysis system (automatic or manual via local or on-broad processing and/or interconnected processing such as network or cloud-computing or other wireless interconnectivity format) PLUS option for circadian rhythm analysis system (automatic or manual) PLUS option for light therapy entrainment (i.e. internet of things including light and/or alarm or music and/or audio controls designed to adjust an individual's circadian rhythm cycle) PLUS option for meditation and/or relation music and/or audio PLUS option for linkage of said one or more therapy types to be linked to biofeedback including processed brain signals (i.e.
  • EEG EEG
  • other physiological signals i.e. temperature, oxygen saturation, heart-rate, perspiration or galvanic skin resistance, ECG, EMG, EOG, room light status, subject motion, subject location, subject position, and/or subject activity; (automatic monitoring and model configuration capability, Figore 83)
  • the present invention provides a me ns of determining 0iISil£21 iiLfSi&g2g
  • automatic pre- acquisition signal processing i.e. filtering, sensitivity etc.
  • automatic data-acquisition configurations i.e. analogue to digital sampling rates, sample resolution/steps for each respective monitored, analysed, transmitted, stored and/or displayed channel
  • automatic sensor or electrode location information registered for each monitored channel
  • automatic post-acquisition signal processing i.e. filtering, sensitivity etc.
  • automatic interconnectivity and/or intercommunication relating to data characteristics consideration of "high dependence connectivity monitoring
  • HDCM high-Body Network
  • API/APM adaptive physiological-Body Network
  • fecfe# « d series or monitoring protocols which can be classified include automatically adjusted or upgraded monitoring types and/or levels and/or categorisation and/or scope (or "SCOPE!?' per in clinic and out of clinic study approaches and/or recommendations and/or health insurance requirements or guidelines and/or government health rebaits etc.) along with associated sleep monitoring study scope including type and categorisation of sleep, cardiovascular, oximetry, position, effort, and/or respiratory monitoring requirements);
  • the present invention provides automatic determination and corresponding configuration of the sleep monitoring system configuration
  • said determination can comprise of detecting consumer/non-regulatory versus
  • said determination can comprise of detecting actual study criteria or local regulatory (i.e. health insurance reimbursement or government reimbursement or market clearance body (i.e. USA, China FDA etc.) in contrast or comparison to actual sleep study configuration details;
  • -whereby includes, any of or any combination of (but not limited to) sleep, cardiovascular, oximetry, position, breathing effort and/or respiration measures;
  • Sfef .g iiSSi2S£l 2£! TM ! can include the monitoring of sleep parameters such as (but not limited to) sleep by using 3 active EEG channels, at least one EOG channel and chin EMG channel;
  • Sfegg lSaSdSiMSiL ⁇ can include the monitoring of sleep parameters such as (but not limited to) sleep by using at least 2 active EEG channels (plus separate reference EEG channel), with or without EOG channel or chin EMG channel;
  • Steeg llSfi£ Sil S£L3 can include (but not limited to) the monitoring of sleep surrogate channels such as actigraphy;
  • fenji can include the monitoring of cardiovascular parameters such as (but not limited to) more than 1 ECG lead with option of deriving events;
  • Cf g ⁇ S 3 ⁇ 4C l3 ⁇ 4 ⁇ C ggI ⁇ can include the monitoring of cardiovascular parameters such as (but not limited to) peripheral arterial tonometry (such as described in F um 37; F um 38);
  • ⁇ fiIIli ⁇ Lt l S 2Ii SiL.3 can include the monitoring of cardiovascular parameters such as (but not limited to) a standard (1 lead) ECG measure ;
  • S3 ⁇ 4S fe ⁇ £ il£ liSSdi LJ can include the monitoring of cardiovascular parameters such as (but not limited to) derived pulse, such as oximetry;
  • C3 ⁇ 43 ⁇ 4 ⁇ g ⁇ 3 ⁇ 4 ⁇ c ⁇ ggg sa Hgnjf can include the monitoring of cardiovascular parameters (but not limited to) based on other cardiac measures than those detailed in Sleep categorisation 1 , 2, 3 and 4;
  • 0 ife£ ⁇ gg5 £&,-J can include the monitoring of oximetry (but not limited to) finger or ear sensing with sampling of 3 s averaging and at least a 10 Hz sampling rate but preferably 25 Hz;
  • J2 EilQ TM ⁇ lJl2 ⁇ example only can include the monitoring of oximetry (but not limited to) finger or ear sensing with sampling properties less than 3 s averaging and 10 Hz sampling rate;
  • oximetry but not limited to located at an alternative site such as forehead;
  • O il L ⁇ illS2CiiiSSCL5 K can include the monitoring of other oximetry formats
  • Position categorisation 1 can include the monitoring of video or visual position measurement
  • P sg g£ M ⁇ liiilSS TM ! (f° r example only) can include the monitoring of nonvisual position measurement
  • Breai ma effort categorisation 1 can include the monitoring of two respiratory inductive plethysmography measures (abdominal and thoracic measures);
  • fo l£S!iSfi iiili2ILl can include the monitoring of one respiratory inductive plethysmography measures (either abdominal or thoracic measure);
  • Breathing effort cat ortsaiion 3 can include the monitoring of one respiratory inductive plethysmography measures a derived breathing effort measure, such as forehead forehead venous pressure (FVP);
  • FVP forehead forehead venous pressure
  • J3 ⁇ 4 lil lL ffi ⁇ can include the monitoring of other breathing effort measures, such as piezo respiration belt measures; Respiratory scope
  • Respiratory Jl lI fiSJlJ ⁇ (f° r example only) can include the monitoring of thermal sensor;
  • Respiratory ⁇ l Sfi£ ⁇ li£ili 2iil S£LJ can include the monitoring of end-tidal C02 (ETC02) sensor;
  • Respiratory gfeatfi ⁇ can include the monitoring of another respiratory measure
  • i ⁇ Sfi£ iitLi&S 2 can comprise of automatically meshing one or more distributed wireless interconnected monitoring sensors with time- sync ronisati n (i.e. as described in but not limited
  • the present invention provides an automatically connected and configured consumer or professional wearable mobile HMS (including device, corresponding online services, sensors, therapeutic intervention and control with option of biofeedback capabilities) activation linked in accordance to any of or any combination of (but not limited to) : a) monitoring study or HMS goal requirements, b) monitoring or HMS "categorisation" format, c) monitoring study or HMS "type or level” requirements, d) sensor-kit, monitoring-kit, e) professional-authorised and secure opt-in healthcarer, f) consumer services provider, g) professional services provider, h) personal-care- management platform, i) application , j) opt-in practitioner (regulatory - i.e.
  • EEG EEG
  • EOG ECG/Heart rate
  • Chin EMG Chin EMG
  • Limb EMG Respiratory effort at thorax and abdomen
  • air flow via nasal cannula thermistor and/or breathing effort (respiratory plethysmography), pulse oximetry, additional channels for
  • CPAP/BiPAPA levels pressure, C02, pH etc.
  • S ⁇ £J 0i!8l2fi£ ⁇ example only includes the following monitored channels: EEG, EOG, ECG/heart rate, Airflow, Respiratory effort, oxygen saturation; -where said S g ⁇ iLISSSi!2dfi ⁇ example only) includes the following monitored channels: EEG, ECG, airflow, thoracic-abdominal movement, oxygen saturation, body position, and either EOG or chin EMG);
  • Sfee£mo 3 ⁇ 4f ⁇ example only includes the following monitored channels: 2 respiratory movement/airflow, 1 ECG/heart rate, 1 oxygen saturation;
  • Jl iifiJSg f ⁇ example only includes the following monitored channels: minimum of 3 channels including Arterial oxygen saturation, airflow, optionally thoracic-abdominal movement, along with the direct calculation of AHI or RDI measure; -The present invention further provides a ISil J2l l l£f! ! ⁇ whereby the AMD function works in conjunction with the A ⁇ C S SQ£
  • the AlCC, SQE and SQI&C functions are detailed in the patient interface section. Specifically, the SQE system tracks the status of the electrode
  • the corresponding control functions are relayed by the SQI&C function to the AMD system.
  • the A&CD monitoring mode in then adjusted in accordance to the validity and connections status of the sensors and electrodes at any point in time.
  • Figure 83 ;[3:Y]) if activated prompts the A&CD system to configure the monitoring operational mode in accordance to the ISA format and signal quality.
  • the operator interface is configured in accordance to the operator manual mode selection ( Figure 83 ;[4]).
  • the integrated attachment sensor ( Figure 83 ; [6]) is connected to the patient interface module [7] which detects and determines the ISA format, along with the sensor attachment and quality status ( Figure 83: [8]). This information is input as part of the decision matrix involved with the automatic identification and channel characterisation ( Figure 83 ; [9]; AlCC) system.
  • the mode determination ( Figure 83: 5) then enables the various affiliated systems including the dynamically linked signal conditioning ( Figure 83: [11 ]) and the dynamically linked analysis conditioning ( Figure 83: [12]) system to configure or adapt the A&CD systems corresponding to operational, environment and signal quality conditions.
  • the combination of on-line signal quality tracking and the AMD enables special on-line adaptation such as when the AEP click stimulus is disconnected, whereupon the system can revert from the a hybrid (AEP and EEG-based) to an EEG-based monitoring mode.
  • the present invention further provides a !SilSljsJl
  • the AlCC system is designed to automatically detect the integrated sensor attachment (ISA) system configuration (i.e. Figure 82) and also per (but not limited to Figure 1; Figure 28; Figure 31; Figure 38; Figure 46; Figure 55) other monitoring system examples (i.e. but not limited to) the wearable mobile or other monitoring system monitoring modes (hybrid, EEG based etc.) and format (standard or advanced). Additionally, the specific signal filtering and processing characteristics required for each respective channel can be automatically configured. In this way a single quick snap ISA connection (for example) can automatically prepare the system for monitoring.
  • ISA integrated sensor attachment
  • the present invention further provides a ISft!lJLSlJl ⁇
  • the said Signal Quality Estimation (SQE) System enables continuous tracking of the input signal's integrity and overall quality. Additionally, such measure can be continually compared to predetermined and acceptable signal ranges, limits, and other important characteristics.
  • the SQE function works in conjunction with ⁇ £H 5£ 2 fiiii! ⁇
  • the present invention further provides a me ⁇ s of $emot/E$&ctroc$& Quality indicator
  • the said SO1 ⁇ 2C system can be integrated within the patient interface (such as Somfit or other wearable monitoring devices (i.e. but not limited to Figure 1 wearable device examples) or monitoring head-box (i.e. for clinical or laboratory monitoring) provides a number of key functions including visual user-prompts indicating the connection and sensor quality status at all times.
  • patient interface such as Somfit or other wearable monitoring devices (i.e. but not limited to Figure 1 wearable device examples) or monitoring head-box (i.e. for clinical or laboratory monitoring) provides a number of key functions including visual user-prompts indicating the connection and sensor quality status at all times.
  • the LCOIM system generally refers to the use of active on-line impedance measurements undertaken in such a manner that the measurement periods are flagged and excluded from the downstream analysis results. Furthermore the impedance measurement periods can be minimised by measuring a transient response signal versus conventional steady state waveform measurement methods.
  • the present invention enables a combination of passive signal quality tracking (i.e.
  • the present invention further enables active impedance measures to be interleaved with monitored signals is such a manner that measurement periods (which can cause monitoring signal disturbances) can be limited to "non-critical” or “less-critical” monitoring periods (i.e. not during periods that are critical to the determination of sleep staging epochs (i.e. not during transitional sleep stages and the like).
  • Non-critical periods can also be predefined as periods when vital measures such as spindles or K-complexes marking sleep stage changes are not evident.
  • the present invention's AC&R system incorporates a series of algorithms capable of eliminating or minimising noise or artifact.
  • Automatic online artifact routines can identify the specific severity level, interval and classification of artifact. Reduction or removal of the effects of unwanted background physiological artifacts including EMG signal intrusion, eye-blinks, EOG intrusion, arousals (various neural and autonomic categories to be included), body movements, movement time, and unwanted PAMR signal intrusion can be automatically and , continuously tracked and implemented online.
  • the present invention enables high tolerance and quality sustained signal monitoring during severe interference from electrical, EMF and other body movement artifact and other signal interference sources.
  • the present invention can incorporate a high impedance ⁇ i 3 ⁇ 4x ⁇ configured to operate like an antenna for noise and sample interference in a manner that the signal characteristics or environmental interference can be monitored and/or stored.
  • the environmental noise can be characterised in terms of determining filtering types and characteristics required to minimise or eliminate noise form monitored signals channels. For example, ®£
  • £ftS !fl can be used to help cancel out noise in input channel of interest, by way of phase shift, magnitude adjustment and ultimate unwanted cancellation of unwanted environmental noise, i.e. a noise cancellation channel can be created and then phase shifted to be precisely equal but opposite phase (180 degree phase shift) to noise present in other signal channels, in order to null out or cancel out unwanted noise.
  • the present invention enables a health ment system w ic "appropriately" (i.e.
  • aspects of the present invention include the capability to "appropriately" assess contradictions, side-effects, checks against contradictions between patient medical history (i.e. allergies, reaction with certain drugs etc.) and prescribed medications) and alert or notify
  • aspects of the present invention include the capability utilise two-w y separated or buffered data access so that a guaranteed disconnect and both privacy security of information exists between subject/ patient and supplier to conceal private ailments and medical history or privacy in general (i.e. private medications or the like with "healthpal” with health-sensitive and health specialist security).
  • the present invention provides a means of characterising an individual's gait at motion characteristics, including any measure of the interrelationship of motion between an piuraiity of body extremities or limbs, the present invention further including any of or any combination of (but not limited to):
  • the present invention provides a means of analysing the motion characteristics of a subject/patient by way of analysing (i.e. s #e a ana sis such as FFF and segmentation of specified frequency bands applicable to different components of a subject's motion, including analysing the tmgeeaey feared o/wacfer sll s assootared 5 ⁇ 3 ⁇ 4am am? suamjs and c ⁇ i?ea??a3 ⁇ 4? fftese m? s$. ⁇ aaas 3 ⁇ 4w3 ⁇ 4 leg steps a? terras o/pft sio nature and synchronisation between signals.
  • Said motion characterisation can include resolving motion properties such as any of or any combinations of the linear fer3 ⁇ 4?rft (i.e. millimetre), cyclic Urn® (i.e. seconds), regularity (i.e.
  • ioaftror?isalfoa ami pftasie interrelationship between arm swing and corresponding ieg motion characteristics will change over time with the progression of movement and neural disorders, and particularly during the navigation by subject of more challenging motor control circumstances associated with corners, changing direction and the like.
  • analyses of motion sensor out puts can comprise of the deployment of nonlinear dynamic based (NLDB) analyses transformations whereby, for example only, the regularity (i.e. deterministic or regularity of arm swing or leg stride motion characteristics can be measured in terms of non-linear dynamic characteristics indices such as (but not limited to) complexity or entropy;
  • NLDB nonlinear dynamic based
  • analyses of mote sensor satpats can comprise of the deployment of pattern recognition analyses transformations whereby the l®g stride and arm swing motions can mapped and recorded with signal characterisation in order to characterise gradual changes in pendulum action, fluency, flow of motion, synchronisation with any other limb or extremity as a measure of subtle or more severe deterioration or improvement applicable to reversal/recovery or degradation of movement, neural or nervous disorders including any of "events of interest/EO (per ⁇ DEFINITION" detailed” in abbreviation table at rear of this document);
  • the present invention further incorporates means of combining locartooat tracking such as
  • GPS information to map out an individual's motion characteristics in a manner whereby progressive deterioration over a period of time and as it relates to different category of
  • movements i.e. walk, jog, stair climbing, sports or gym exercise systems such as treadmills, running
  • gait difficulty i.e. mild, moderate or severe manoeuvring difficulty, straight line pathway, etc.
  • gait or balance output measures i.e. such as but not limited to any or any combination of: »measures of interrelationship (degree of pft sfc synchronisation between any two or mom body limbs or extremities or main body motion sensing locations);
  • motion analysis or characterisation of an one or limbs or extremities and/or main body section(s) comprises any of or any combination of (but not limited) to any length of arm swing (linear or arc millimetres) walking fluency; walking arm movement; swinging arm pattern;
  • Said motion characterisation can include resolving motion properties such as any of or any combinations of the linear length (i.e. millimetre), cyclic time ( i.e. seconds), regularity (i.e. deterministic or regularity of arm swing or leg stride motion characteristics; and pamfeforo mofesw of esoft am? st 3 ⁇ 4?
  • the present invention further comprising of analyses of association, comparison or other phase, or cyclic or other means of determining the interrelationship between a plurality of said extremities, limbs or body section motion of a subject/individual;
  • the present invention provides measurement assessment and characterisation of combined SHO SSI slesa and motion analyses applicable to prognosis or diagnosis of movement or neurological disorders including "health conditions of interest” or “events of interest/EOI” (per ⁇ DEFINITION” detailed in abbreviation table at rear of this document);
  • the present invention incorporates a «?®a «s of correlating SBD (per Figure 75) and/or motion analysis nwans such as described elsewhere in this document;
  • the present invention provides a process as part of microprocessor programmed within one or more of any of or any combination of software application(s), mobile device(s), wearable technology, or interconnected communication systems(s) (i.e. SAAS including Cloud-computing services , LAN, WAN, NAS etc.) capable of providing circadian clock health management by way of inputs such as but not limited to any of or any combination of inputs functions, application or systems covered here in Figure 96.
  • SAAS including Cloud-computing services , LAN, WAN, NAS etc.
  • -Block 1 incorporates inputs including new and current environments time-zones and/or solar daylight conditions, temperature changes, information on population studies or health information such as typical sleep deprivation or sleep urge/propensity associated with various degrees of circadian clock asynchrony (including incorporation as part of self-learning algorithm processes (i.e.. but not limited to self-learning processes per examples .);
  • - Questionnaire activation with interaction via subject/patient/user and information or related derived information or associated outcomes as they relate to characterisation of an individual's sleep/wake cycle and/or circadian clock cycles; i.e. example (but not limited to) questionnaires include Horne- Ostberg Morning-Eveningness Questionnaire (MEQ); Epworth Sleepiness Scale (ESS); Kunststoff Chronotype Questionnaire (MCTQ) etc. (see also CC HMS processing/determinations); -endogenous circadian cycle;
  • MEQ Horne- Ostberg Morning-Eveningness Questionnaire
  • ESS Epworth Sleepiness Scale
  • MCTQ Kunststoff Chronotype Questionnaire
  • -actual sleep-wake cycle i.e. timing and structure of sleep and waking such as derived from monitored sleep parameters and/or associated measures including (but not limited to Figure 77;
  • Point of care body fluid measures such as melatonin (i.e. the rhythm of the melatonin concentration provides an optimal circadian phase marker for humans) or Cortisol (i.e. measures via periodic testing of samples of saliva, blood/plasma or urine or associated blood/plasma, saliva or urine sampling test trips and related point of care testing systems, with option of automatic integration or interface with mobile health monitoring or tracking systems);
  • melatonin i.e. the rhythm of the melatonin concentration provides an optimal circadian phase marker for humans
  • Cortisol i.e. measures via periodic testing of samples of saliva, blood/plasma or urine or associated blood/plasma, saliva or urine sampling test trips and related point of care testing systems, with option of automatic integration or interface with mobile health monitoring or tracking systems
  • minimisation/monitorinq i.e. see also Figure 45 minimisation process
  • source localisation applicable to an individual's health management and associated markers of consciousness, sleep/wake homeostatic or circadian rhythm determination/monitoring, brain centres regulating wakefulness and sleep (including neuromodulators and neurotransmitters producing EEG activation, such as histamine, acetylcholine, norepinephrine, hypocretin and glutamate),
  • brain regions but not limited to: -the thalamus or associated areas;
  • -posterior cingulate or associated areas medial parietal cortex or associated areas;
  • -hypothalamus or associated areas anterior (ventrolateral preoptic nucleus, responsible for promoting sleep) or associated areas;
  • -posterior tuberomammillar nucleus, responsible for generating histamine; medulla oblongata; orexin [A/B], relating to wake-promoting neural activity
  • -midbrain and pons central point of the generation of coeruleus (norepinephrine; NE), raphe nuclei
  • sleep timing information such as the sleep midpoint (i.e. between sleep onset time and wakeup time);
  • accelerometer outputs followed by segmentation of likely source or causation of activity and then association of said categorisation of movements with sleep, wakes and other activities as a means of deriving final sleep/wake/activity cycle of subject/patient/user;
  • DLMO "Dim light melatonin onset”
  • the present invention can provide a point of care testing system which is automatically interfaced to a mobile or wearable device or via interconnectivity to a communication network or system in order to enable saliva, blood/plasma, urine sampling (i.e. melatonin assays including (but not limited to) chemically impregnated test strips designed to react in accordance for the presence or concentration of melatonin and then have option for said test-strips to be automatically scanned and analysed as a means of outcomes to be indicated or communicated);
  • saliva, blood/plasma, urine sampling i.e. melatonin assays including (but not limited to) chemically impregnated test strips designed to react in accordance for the presence or concentration of melatonin and then have option for said test-strips to be automatically scanned and analysed as a means of outcomes to be indicated or communicated
  • an algorithm capable of providing the calculation of the time of therapy usage should be applied in accordance to a subject/patient/user's internal circadian versus external environment clock time conditions.
  • automatic, patient-wearable technology and/or mobile device integrated systems can contribute to the incorporation of circadian principles in order to enable the determination of important therapeutic treatment (i.e. alignment or adjustment between circadian (internal) and environment (external) clock cycles for optimal health, safety and occupational hazard minimisation.
  • the said therapy can extend to optimising subject/patient/user room, alarm clock settings, or other environment or temperature conditions to personalised versus general conditions;
  • sleep midpoint computation based on sleep/wake monitoring of the present invention and/or MEQ, MCTQ questionnaires and/or subject/patient/user sleep journals (i.e. start sleep period time, lights off for sleep time, awakening sleep time) in order to determine an approximation of internal circadian cycle clock time;
  • the present invention incorporates an alarm and/or sleep eeaehmg determination capability and, along with an algorithm designed to assist or guide people with notification of optimal rest periods (i.e. naps or recovery sleeps) the user can set preference (i.e. for a driver or pilot for the purpose of drowsiness occupational-risk aversion or mitigation, for example) in order to enhance vigilance or performance capabilities, whereby the present invention enables subject/user to enter desired sleep period and selection of "best sleep recovery strategy" means (said means can associate any CC determination and/or wake, sleep, REM or arousal state with determination of wake function (i.e. alarm via audio, vibration, including vibration function within monitoring wearable device (i.e. forehead Somfit/forehead- strip etc.);
  • -Determination of sleep/wake parameters such as (but not limited to) sleep onset, wake-up time, wake bouts, sleep efficiency, mid-sleep time etc.) based on any of or any combination of sleep/wake monitoring data or associated outcomes, and/or actigraphy (i.e. accelerometer outcomes measures); -Determination of circadian variables such as circadian relative amplitude versus cycle time and/or CC maximum amplitude and/or CC minimum amplitude, CC day by day stability (inter-day stability or related fragmentation factor) and/or CC daily stability (intra-day stability or related fragmentation factor);
  • circadian variables such as strength of coupling or correlation between external CC environmental stimulus factors (zeitgebers) versus CC cycle;
  • subject/patient/user goes to bed and awaken up and/or optimally requires/desires to go to bed and awaken) as it relates to special period such as exams, celebrations, illness, associated with or following treatment; associated with or following medication; depression etc.;
  • -Stability of entrainment i.e. dim light melatonin onset: DLMO (marker of body clock time based on measuring saliva prior to subject/patient/user going to sleep) over successive days, week, months etc.
  • DLMO marker of body clock time based on measuring saliva prior to subject/patient/user going to sleep
  • EEG actigraphy
  • CC amplitude by way of any of or any combination of core body temperature, melatonin sample testing, EEG measures, surrogate or derived or estimated body temperature measures;
  • sleep homeostatic characteristics including the increase or decline short- terms or long-term wise as it relates to slow wave sleep (i.e. NREM such as 0.75 Hz to 4.5 Hz): -determination of sleep homeostatic characteristics including the increase or decline long-term or short-term-wise as it relates to REM sleep;
  • NREM slow wave sleep
  • sleep homeostatic characteristics including the increase or decline long-term or short-term-wise as it relates to faster beta waves in active waking and/or slower alpha waves in quiet waking;
  • the present invention can automatically incorporate all CC entrainment factors, indication aspects, alarm clock functions, light detection functions, coaching and/or messaging and/or alert functions, into a single application as part of a wearable or mobile device;
  • the present invention can determine circadian clock nadir factors (i.e. body temperature and/or interval from body temperature nadir to sleep offset) including subject/patient/user's with delayed sleep phase syndrome (DSPS) in order to optimise CC entrainment (i.e. light therapy including glasses with blue light projected towards subject/patient/user retina as a stimulus - can be blocked form forward projection based on shaded or blocked section of glasses in order to minimise obtrusive or obvious nature of such treatment);
  • circadian clock nadir factors i.e. body temperature and/or interval from body temperature nadir to sleep offset
  • DSPS delayed sleep phase syndrome
  • the present invention can track sleep-wake rhythms and characterise a lack of clearly discernible circadian patterns of sleep-wake time, as a marker or potential prognosis of irregular sleep-wake rhythm; -The present invention can in incorporate sleep-wake rhythms and characterise a lack of clearly discernible circadian patterns of sleep-wake time, and/or questionnaire outcomes relating to excessive sleepiness , unrefreshing sleep, and/or insomnia that vary in accordance to work schedule as a marker or potential prognosis of shift work disorder (SWD) ;
  • SWD shift work disorder
  • HMS Health Management System
  • a control or measure of control to maintain or correct i.e. move circadian and sleep wake clock into closer synchronisation
  • the phase relation between the subject/patient/user circadian clock cycle (i.e. prior sleep/wake cycle) and the current environment clock cycle (i.e. solar clock, time-zone or schedule requirements of subject/patient/individual) and/or target clock (i.e. desired subject/patient/user and/or the subject/patient/user desired or preference clock or schedule i.e. any of or any combination of considerations including wake cycle, sleep cycle, work cycle, recreation cycle, fitness cycle, relaxation cycle, travel cycle, work-shift cycle, study-cycle, exam- peak-performance-cycle, jet-lag cycle, current time-zone cycle, one or more new time-zone cycles etc.
  • Circadian clock entrainment outputs or outcomes i.e. but not limited to circadian clock interactive (or one way information access) options (CCIO);
  • CCIO include any combination of (but not limited to) - map display or application with map functions or indications or associated annotations or information, with automatic and/or dynamic data exchange or update options;
  • circadian clock entrainment stimulus or environmental adjustment decision matrix or control of environmental or therapy deployment i.e. any of but not limited to light-therapy, with automatic and/or dynamic data exchange or update options; -temperature or environmental changes, with automatic and/or dynamic data exchange or update options;
  • light stimulus can include (but is not limited to room or glasses or other head mounted/applied system including concealed steady state light therapy means using forward light blocking means and/or less obvious subject/patient steady state light and light colour selection or light-colour control properties;
  • the present invention includes any combination of or any of motion tracking (such as actigraphy or accelerometer measures), body temperature, GSR measures, pulse measures, light measures as a means of approximating or determining and/or indicating a subject/patient/users circadian clock cycle;
  • motion tracking such as actigraphy or accelerometer measures
  • body temperature such as body temperature
  • GSR measures such as body temperature
  • pulse measures such as light measures
  • light measures as a means of approximating or determining and/or indicating a subject/patient/users circadian clock cycle
  • mapping application i.e. geographical or road map
  • an indications or annotation with the option of additional notes or associated information, relating to various travel scenarios indicating or symbolising;
  • the present invention enables a range of clock or watch face programmable functions, including a sequence of watch displays which can be toggled through and selected as required.
  • any combination of solar-cycle, sleep-wake cycle, time-zone, social-clock, and associated phase shift with circadian clock can be programmed by users, presented as default library of displays and/or programmed display formats shred amongst different users.
  • CC HMS enables a community or private select grouping function whereby healthcare specialists can coach, guide, assist and intervene in tracking, diagnosing and supporting an individual's occupational safety aspects, sports performance aspects, general health aspects, depression and other psychological disorders greatly impacted by appropriate CC management ( Figure 96.; Figure 97).
  • a subject's phase response curve i.e. a subjects inbuilt circadian curve phase relationship with external clock factors, including social, time-zone, work, work-shift, study requirements etc.
  • DSPD delayed sleep phase disorder
  • ASD advanced sleep phase disorder
  • light intensity and type i.e. visible blue light with short wavelength, and stronger melatonin suppression affect can be deployed as part of an automatically computed CC entrainment treatment regime, versus longer wavelength light
  • timing functions of such light therapy i.e. light-therapy in the evening can enable CC phase delay, while light therapy in the day can product CC phase advancement
  • control entrainment factors i.e. lighting timing and/or lux intensity and/or melatonin dosage and administration timing or recommendation
  • control entrainment factors i.e. lighting timing and/or lux intensity and/or melatonin dosage and administration timing or recommendation
  • the present invention can advise/coach and/or automatically adjust said CC entrainment in accordance to subject/patient/user preferences, selections or personalised scenario choices (i.e. more aggressive adjustment over a shorter period of days or more moderate CC adjustment over a longer period of days);
  • CC offset therapy i.e. light therapy, melatonin medication, adaptation of homeostatic sleep factors (i.e. optimal increasing of a subject/patient/user's awake period to enable higher quality sleep and alignment of CC with sleep patterns or vice versa
  • homeostatic sleep factors i.e. optimal increasing of a subject/patient/user's awake period to enable higher quality sleep and alignment of CC with sleep patterns or vice versa
  • CC computed parameters as part of automatic entrainment programming of CC treatment systems (i.e. such as bright light therapy including glasses or sunglasses (i.e. half- shielded glasses, for example only, tinted in upper section of glass lenses only), whereby said glasses can include reflective oculography capable of both entrainment light-therapy and/or detection of eye-lid movements and/or opening as a marker of drowsiness in order to enable biofeedback entrainment capabilities in order to adjust for CC cycle offset factors and/or sleep propensity and/or sleep urge factors;
  • CC treatment systems i.e. such as bright light therapy including glasses or sunglasses (i.e. half- shielded glasses, for example only, tinted in upper section of glass lenses only)
  • said glasses can include reflective oculography capable of both entrainment light-therapy and/or detection of eye-lid movements and/or opening as a marker of drowsiness in order to enable biofeedback entrainment capabilities in order to adjust for CC cycle offset factors and
  • CC confidence level factors i.e. accuracy - i.e. error factor
  • the present invention enables all these functions and capabilities to be incorporated into one or more wearable or mobile devices (i.e. smartwatch, mobile phone, Somfit sleep monitoring headband and/or other covered elsewhere at any section within this patent application document (Figure 1):
  • iock 101 CIRCADIAN CLOCK (CC) HEALTH MANAGEMENT SYSTEM (HMS) DISPLAY INDICATIONS -A nub of the present invention's personal health management system is to automatically determine and indicate, coach, alert, message, CC entrainment stimulation applicable to subject/patient/user based on CC input factors, a range of scenarios , covering sleep quality and length relating to the interrelationship or the manner the said subject works with or against their natural CC;
  • the present invention provides entrainment adaptive monitoring (EAM) system comprises of 4 stages including: STAGE 1 providing initial monitoring and analysis goals (i.e.
  • SWP sleep/wake process
  • CP circadian process
  • TP therapeutic/biofeedback Personalised-Preferences
  • STAGE 2 wearable technology customisation/minimisation
  • STAGE 3 Wearable technology customisation/adaptation
  • STAGE 4 incorporating analysis review determination (see also self-learning algorithm with artificial intelligence or expert system analysis processes per Figure 77; Figure 7$; Figure 79) Entrainment or therapeutic determination.
  • the Sleep/wake/circadian entrainment adaptive monitoring (SEAM) system comprises of 4 stages including: Stage 1 providing initial monitoring and analysis goals (i.e. Goal determination of
  • SWP sleep/wake process
  • CP circadian process
  • W&LP Work and Lifestyle Personalised-Preferences
  • Stage 2 including wearable technology customisation/minimisation, Stage 3 Wearable technology customisation/adaptation, Stage 4 incorporating analysis review determination, 5) Entrainment or therapeutic determination.
  • the upper section presents a circadian and homeostatic integrated
  • CHAISM sleep/wake/work/recreation/relaxation management
  • the basic entrainment adaptive monitoring (BEAM) system comprises of:
  • FIG. 1 LEFT TOP: figure presents example of a subject/patient wearable neuro- sleep/fitness/health management systems comprising applied forehead sensor (Somfit) using headband attachment [2], eLifeBAND (arm phone/entertainment/device holder) [9], eLifeWATCH [13], RIGHT-TOP: sleeping subject with eLifeCHEST [3], eLifeWATCH [5], eLifeWRIST [8] and Somfit [1 ] devices LOWER RIGHT: eLifeWATCH with sensor monitoring platform. LEFT LOWER: forehead applied sensor incorporating self-adhesive attachment without requirement of head band attachment. gure wrist (eLifeWRIST) with monitoring and health/fitness/sleep function or performance indicator.
  • Somfit headband attachment
  • eLifeBAND arm phone/entertainment/device holder
  • RIGHT-TOP sleeping subject with eLifeCHEST [3]
  • eLifeWATCH [5] eLifeWRIST
  • the display indicator can be programmed to indicate, for example, sleep/wake factors on the left-hand side of display dial (i.e. between the typical 6 o'clock and 12 clock dial range, whilst the right hand side of the 6 to 12 o'clock range can be programmed to indicate daytime fitness and other health parameters.
  • the system could be programmed to indicate overall sleep quality based on, for example, the subject/user achieving at least say within 20% of the total REM sleep time and non-REM deep-sleep time (say total of N2, N3) compared to the normal quality sleep requirements (i.e.
  • user may toggle through indicator modes such as sleep/wake goals (i.e. sleep/wake target for quality sleep tracking) or actual outcomes (i.e. actual sleep/wake outcomes including sleep- deprivation, circadian delay factors etc.) versus goals.
  • user/subject can toggle through indicator modes such as fitness goals (i.e. steps, motion, activity etc.) versus relates goals.
  • the toggling or switching through display modes can be activated via gesture or tapping/shaking means i.e. detected by Somfit module on-board accelerometer). Similarly all these functions can be integrated as part of a smart or computer-based watch system.
  • a high level user interface graphic drag and click type application can allow user to program their somfit module indicator system and/or the compatible computer based watch-face indicators functions or cover these and other measures.
  • Eg3 ⁇ 4!3 ⁇ 4L ⁇ Diagram of sleeping subject with range of wearable companion health tracking devices.
  • CLAIMS - Somfit refer abstract:, description igu es, applicable claims sections or subsequent divisional application .
  • Patient wearable smart heal h watch device Incorporating any combination of:
  • Integrated microphone sensor RHS:
  • ⁇ Cardio 360 SAAS including cloud-computing services or NAS
  • Patient wearable smart health watch device incorporating any combination of:
  • NAS network application services
  • SAAS including cloud-computing services or other network or point to point interconnection
  • wireless gateway/interconnection-capability with wearable device such as but not limited to band or watch
  • One or more motion or movement detection sensors or systems incorporating capability for linear (i.e. spectral analysis) and non-linear (i.e. spectral entropy or associated
  • Integrated function per above motion detection or separate posture detection and/or fall- detection and/or step or run status and/or other gate parameters;
  • Gyrometer Xo enhance posture/position/fall-detection ;/gate tracking capabilities;
  • GPS geopositioning system
  • ECG integral electrocardiograph
  • One or more light sensors with option of smart watch light combined light analysis function for enhanced environmental light determination i.e. sleep statistical analysis outcomes
  • the present invention incorporates processing capabilities whereby extensive or additional processing requirements can be undertaken by means of distributed or parallel processing systems including (but not limited to) accompanying processing systems, interface to wireless network such as (but not limited to) network application services (NAS), cloud-computing services or other network or point to point interconnection (Figure 13).
  • NAS network application services
  • Figure 13 point to point interconnection
  • the present invention incorporates health-carer "opt in” functionality.
  • the present invention enables the system user to opt-in (enables approved health-care workers to be designated and authorised by the system user), in order to ensure only user selects who can access what data, thus ensuring privacy and data security.
  • users can request medical "op-in” or "Link-in” status for their personalised "health-network” (i.e. general practitioners, dentists, chiropractors, osteopath, chiropodist etc.).
  • An example of the present invention embodiment screen displays includes a watch mode
  • Example embodiment of watch-body modular sensor platform system incorporating PHOTO- PLETHYSMOGRAPHY and/or OXIMETERY PLETHYSMOGRAPHY and/or TEMPERATURE and/or spring-pressure-loaded or fixed ELECTROPHYSIOLOGICAL (i.e. conductive rubber) or SKIN GALVONIC SESNOR (GSR) monitoring electrodes and/or DOPPLER ULTRASOUND MONTORING and/or TONONOMETER MONITORING (vascular monitoring) sensor system and/or LIGHT DETECION SENSOR and/or MICROPHONE sensor ( Figure 7).
  • ELECTROPHYSIOLOGICAL i.e. conductive rubber
  • GSR SKIN GALVONIC SESNOR
  • STEP 1 Go to AMAZON or eHealthSHOPCART and click to buy eLifeWATCH for your personalised healthcare everywhere with inbuilt temp; pulse; activity/position; skin/GSR; pleth-oximeter; sound; light .
  • the modular rear cover provides specialised eLifeWATCH options including Doppler/ultrasound vascular functions (patent pending), plethysmography oximeter (patent pending), vascular pressure pulse sensing system (patent pending), interstitial glucose (patent pending), blood-pressure analyser, etc.
  • eLifeWATCH covers eHealthMEDICS current and future generation applications and services.
  • STEP 2 Go to AMAZON or eHealthSHOPCART, eHealthSENSORS , or eHealth
  • OPTIONAL While you are there or alternatively go to eHealth DATAPLAN • STEP 3: Go to eHealthYOU or eHealthMEDICS and "opt-in" your personalised health community.
  • ⁇ 2 CM, 4CM and 8CM spaced electrode pairs come in wide (6mm) medium (4mm) and narrow (3mm) options, enabling the magnetic-aligned sensor electronic module to easily align and faultlessly snap connect, virtually invisible and with minimal obtrusion.
  • Peel-backing paper off sensors attach fully charged magnetic-aligned (patent pending) sensor modules and watch the eLifeWATCH indictors stop blinking.
  • the invention a subject wearable device for body, head, limbs or body extremity attachment or application Including but not limited to wristband, watch or mobile monitoring, sensing or communication devices with interface capability to monitored subject and/or interface capability between wearable devices and a "watch-case modular sensor platform” and/or “watch-face modular sensor platform” and/or “watch-body modular sensor platform” ⁇ Figure 13).
  • a "watch/wristband body" and/or “watch/wristband face” and/or “watch/wristband -back” and/or “watch/wristband strap and/or “watch/wristband buckle” detachable or removable modular sensor platform system includes a watch device containing processing capability whereby an interface between the said "watch-body modular sensor platform” enables any of or any combination of analogue, power, digital or wireless interface in order to enable a range of configurable smart watch devices with a spectrum of environmental or health monitoring characteristics, including (but not limited to) embedded, attached and/or integrated sensors (via watch-back) along with option of automatic processing capabilities as further detailed under sub-headings listed in this document including any health monitoring aspects such as (but not limited to) of sound monitoring; Stethoscope auscultation sensor, monitoring and automatic analysis, classification, tracking and detection capabilities; Acoustic noise cancellation system; Motion detection; REM sleep behaviour disorder (RBD); Pulse wave analysis (PWA) and pulse wave velocity (PW
  • Environmental sensing with alarm or alert or indicator or interface to mobile device associated or messaging, email, phone automated voice message and other information or communication systems, ionisation monitoring, ionisation smoke alarm, methane monitoring, toxic gas monitoring, toxic chemical monitoring and/or C02 gas monitoring, methane gas monitoring and/or thermometer.
  • Multivariate analysis capabilities enable any combination of environmental or health variables to be analysed and generate indicators, alarms and messaging capabilities based on exceeding baseline normal or safe operational regions or any pre-determined combinations or clusters or events or health conditions or environmental conditions of interest or concern.
  • Figure 6 eHealthWATCH incorporating programmable watch face with heath indications, health monitoring applications, monitoring setup and select applications, and sensor monitoring platform .
  • Figure 7 eLifeWATCH with health monitoring sensor examples.
  • FIG. 8 Example of health wearable monitoring companion web "shop” application.
  • Figure 10 eLifeWATCH gesture or button display and menu toggle selection.
  • Figure 11 eLifeWATCH setup and signal validation example application screens.
  • Figure 12 Smart health watch gesture control interface.
  • Figure 13 eLifewatch with smartphone sensors interfaces and wireless information access system (i.e. NAS, SAAS, or cloud-computing services).
  • Figure 13 eLifewatch with smartphone sensors interfaces and wireless information access system (i.e. NAS, SAAS, or cloud-computing services).
  • the present invention provides a incorporates into a patient wearable device such as ear phone(s) one or more integrated (embedded or attached) sensors ( Figure 14) capable of monitoring one or more physiological parameters, enabling the present invention to function as a physiological monitor and mobile wireless device holder.
  • a patient wearable device such as ear phone(s) one or more integrated (embedded or attached) sensors ( Figure 14) capable of monitoring one or more physiological parameters, enabling the present invention to function as a physiological monitor and mobile wireless device holder.
  • the present invention provides a sensor capable of detecting fine tremor movements ranging from cardioballistogram or tremors to coarser vibrations or movements.
  • a sensor can comprise of a membrane or sensor (such as accelerometer) capable of detecting movement or motion and generating a signal or measure associated with said "movement or motion”.
  • the present invention enables access to said information related to "signal or measure associated with said movement or motion” in order to generate directly access “information” or further “transformations or transpositions (linear or non-linear)" of said "information” in order to associate such "information” with sleep states, including REM sleep state in order to identify possible phases of physiologically generated tremor associated with incidences of rem behaviour disorder.
  • the present invention provides a incorporates said information relating to "signal or measure associated with said movement or motion" or RBD in the decision process or control process applicable to optimise the administration of appropriate drug therapy in order to achieve predetermined outcomes in terms of any of or any combination of minimising RBD and/or tremor conditions during pre-specified sleep or wake states.
  • EMG via carbonised rubber sections of earphone inserts where conductive carbon sections of the earbuds can be positioned in a manner where skin contact and conduction of small electrical signals is possible between two or more of these carbon conductive regions (i.e.
  • galvanic skin resistance can be determined form the measurement of constant current transmitted between two said conductive sensors as a means of determining the
  • ⁇ EEG including vestibular signals via carbonised rubber sections earphone inserts where a conductive electrode such as carbonised rubber or other electrical conductive material can detect signals around the brain cochlear region (i.e. PAMR as a measure of auditory muscle responding to sound levels (for example), which can be deployed as a measure of excessive volume and potential auditory damage of a subject).
  • PAMR brain cochlear region
  • ECG via carbonised rubber sections earphone inserts i.e. conductive sensors as a means of determining small but detectable signal measures evident throughout the skin surface as a marker of cardiology function and heart rate variability;
  • Audiology acoustic testing capabilities comprising any of or any combination of hearing assessments (i.e. useful with earplug usage as continued high volume usage of earplugs, and particularly with sensitive hearing physiology amongst younger children or adults, van lead to permanent hearing damage if left unchecked or undiagnosed (i.e. the present invention provides a means of automatically enabling hearing screen tests and audiology tracking of same within a mobile device, so that a parent or individual can be recommended for further medical assistance where signed may suggest hearing deterioration or possible risk.
  • hearing assessments i.e. useful with earplug usage as continued high volume usage of earplugs, and particularly with sensitive hearing physiology amongst younger children or adults, van lead to permanent hearing damage if left unchecked or undiagnosed
  • the present invention provides a means of automatically enabling hearing screen tests and audiology tracking of same within a mobile device, so that a parent or individual can be recommended for further medical assistance where signed may suggest hearing deterioration or possible risk.
  • the present invention enables hearing tests to be contained within a mobile phone or music or hearing aid or any combination of same system(s), in order to provide automatic and hearing screening tests, coaching and elevated awareness, as a means of mitigating the potential of more serious unchecked hearing damage amongst children and adults, alike.
  • the present invention also has the means of utilising such hearing test outcomes as measure of auditory volume sensitivity, spectral auditory sensitivity, auditory conductive characteristics, auditory directional hearing characteristics (i.e. multiple spatially distributed speakers within earbuds can change and compensate for spatial directivity disorders) in order to automatically compensate each
  • subject/patient-specific optimal auditory processing requirements in accordance to user's preferred mode (i.e. speech intelligibility, music listening, noisy room conversation focus, classroom audibility etc.).
  • the present invention can provide an audiometer function as part of a mobile device and earplugs or headphones, whereby the headphone or earplugs can generate a series of sounds including frequencies bursts, frequency pips, MMN, odd-ball responses, auditory steady-state responses (ASSR) of other AEP test paradigms capable of contributing towards the assessment of an individual's hearing or attention/awareness (i.e. sedation, alertness, concentration (such as applicable to diagnosing autism spectral disorders, ADHD etc.).
  • ASSR auditory steady-state responses
  • a companion forehead or other EEG head monitoring system (Le, per, but not trailed to, monitoring examples Including n of or n combination of ex m les presented In Figure 2; Figure 3; Figure 4; Figure 16; Figure 21; Figure 23; Figure 24; Figure 25; Figure 27; Figure 28; Figure 45; Figure 46; Figure 47; Figure 48; Figure 49; Figure 50; Figure 51; Figure 52; Figure 53; Figure 54; Figure 55 ⁇ can be used to monitor myogenic (i.e. PAMR) or neurogenic responses to auditory sound or stimuli (i.e.
  • myogenic i.e. PAMR
  • neurogenic responses to auditory sound or stimuli i.e.
  • tone pips or other frequency pips such as but not limited to presence of tone pips or other frequency pips, tone bursts or frequency generated test sequences etc.
  • AEP auditory evoked potential
  • the present invention can provide an audiometer function as part of a mobile device and earplugs or headphones, the headphone or earplugs can generate a series of test sequence sounds including frequencies bursts or frequency pips.
  • the present invention can include electrophysiological sensors attached or embedded
  • the present invention can include one or more vibration (i.e. speaker) vibration sensor capable of vibrating at a range of frequencies in order to emulate the characteristics of a tuning fork whereby the individual can be tested sound conductivity (i.e. a measure or screening assessment of conductive hearing loss) versus the sensor function of the subject's auditory physiology.
  • vibration i.e. speaker
  • sound conductivity i.e. a measure or screening assessment of conductive hearing loss
  • the present invention can include one or more vibrating probe(s) (i.e. speaker or other vibrating element embedded or attached to earplug in a manner where the probe can vibrate similar to a tuning fork used to evaluate conductive (hearing loss) be on sensor capable of vibrating at a range of frequencies in order to emulate the characteristics of a tuning fork whereby the individual can be tested sound conductivity (i.e. a measure or screening assessment of
  • vibrating probe(s) i.e. speaker or other vibrating element embedded or attached to earplug in a manner where the probe can vibrate similar to a tuning fork used to evaluate conductive (hearing loss) be on sensor capable of vibrating at a range of frequencies in order to emulate the characteristics of a tuning fork whereby the individual can be tested sound conductivity (i.e. a measure or screening assessment of
  • the present invention can include one or more separate and/or the standard speaker transducer(s) used for generating sound (i.e. embedded or attached to earplug or headphones) whereby any combination of AEP testing and also voluntary responses (i.e. subject taps or indicates with a user interface when they can or cannot hear certain sounds in order for
  • sensorineural i.e. caused by a problem in the auditory nerve or auditory pathways/cortex of the brain
  • the present earbud or headphone system invention can include a means of deploying
  • hearing in noise within said system
  • means can comprise of incorporating separate and/or the standard speaker transducer(s) used for generating sound (i.e. embedded or attached to earplug or headphones) whereby test paradigms comprising any of generating sound sequences in situations with both guiet and noisy surrounding audio conditions (i.e. competing sounds or audio sequences) can be simulated as part of current system.
  • the present invention comprises of a plurality of speakers strategically positioned within the present invention earplug or headphones in a manner earphone that directional sound can be simulated in order to evaluate a subject's ability to distinguish sound from different directions (i.e.
  • the location of speakers at different positions with respect to the ear canal via earbuds or ear structure with headphones can tend to simulate changes in sound direction (i.e. speakers at the top, left, front, back, bottom, etc. can tend to simulate sound direction and assess an individual's neurological processing of sound direction (i.e. with aid of user interface prompting user to indicate perceived changing sound direction based on activating different speaks at different locations in terms of a subject's auditory spatial orientation) .
  • the present invention can enable HINT testing where a number of conditions including (but not limited to) the assessment of a subject's hearing performance under a number of conditions including any of or combination of: generating sentences or sound sequences without competing background noise, generating sentences or sound sequences with competing background noise, generating sentences or sound sequences with competing background noise with a directivity (i.e. simulated with multiple strategically located or position speakers within earplug or headphone system) aspect (i.e. sound perceived as being evolving from in front of subject by way of activating similar sounds and speaker direction (i.e.
  • the present invention provides a means of computing the signal to noise ratio for different conditions based on the determination of the level of loudness required to playback sentences above background noise before a subject can repeat sentences correctly at least 50% of the time.
  • the present invention can use a microphone such as the standard in-built or earbud microphone to record and analyse correctness of subject's ability to repeat sentences (buried or distinguished from the generation of competing background noise).
  • the present earbud or headphone system invention can include a means of incorporating tvmpanoaram hearing assessment within said system, whereby means can comprise of incorporating (i.e. embedded within or as part of or attached to earbud(s)) one or more pressure sensors in both or either of the earbuds or headphones, in a manner that a speaker or other device (i.e. part of earbud or headphones, such as calibrated speaker transducer and/or tiny valve arrangement to generate and measure (i.e.
  • a calibrated pressure sensor capable or measuring pressure in ear canal in a manner where the generated pressure and/or corresponding air generated air volume versus the resulting pressure and/or resulting ear canal air volume and/or pressure help to describe tympanic membrane characteristics such as ear drum perforation) desired pressure and pressure variation) can generate and vary a pressure in the ear canal and measures corresponding pressure or leakage of pressure in order to determine the ear canal volume and determine (for example) the function of the tympanic membrane (i.e. perforation in the eardrum).
  • the present earbud or headphone system invention can include a means of incorporating acoustic reflex test capability within said system, whereby means can comprise of (i.e. embedded within or as part of or attached to earbud(s) 3 main elements (each element can include a separate tube directed at the subject's ear canal and the earbud forms a tight seal with the subject ear canal.
  • the present earbud invention can contain (for example only but not limited to) any of or any combination of an air-coupling tube where said tubes can transmit sound via a speaker, another can connect the ear canal to a microphone, another can be a pressure generation pump (i.e.
  • miniature pump within earbud capable of generating a range of pressures typically ranging between -200 daPa to +400 daPa (1 pascal is equal to 0.1 dekapascal (daPa)), and/or another said tube can couple the ear-canal pressure to a pressure measurement transducer (whereby said tubes can be one or more combined tubes).
  • a series of tones can be generated via the speaker and resulting impedance (via acoustic reflectometery) can be measured at the microphone.
  • the resulting values can be used to generate a graph referred to as a tympanogram comprising of compliance or acoustic impedance corresponding to a range of pressure values.
  • the present invention can include one or more separate and/or the standard speaker transducer(s) used for generating sound (i.e. embedded or attached to earplug or headphones) whereby one or more said speaker transducers are calibrated to generate a known sound pressure level, and where a tone (i.e. such as but not limited to a tine greater than 70 Decibel sound pressure level (DBSPL ) can be presented to subject in order to measure of the subject's stapedius muscle (protects the ear from loud noises, including the subjects own voice which can be 90 DBSPL or more at the subject's eardrum, for example).
  • a tone i.e. such as but not limited to a tine greater than 70
  • DBSPL Decibel sound pressure level
  • the present invention comprises of any of or any combination of sensorineural (i.e. caused by problems in the cochlear,, the sensory organ or hearing), conductive (i.e. caused by problems in outer or middle ear) hearing loss, hearing in noise (HINT), tympanogram
  • acoustic reflex test to evaluate a subject's hearing thresholds, as well as provide
  • Pulse plethysmography and outputs (see A&CD patent) ; ear reflectance-based pulse oximetery contributing to non-invasive measurement of oxygen saturation (Sp02) and pulse rate (PR), along with outputs and contribution to measures including pulse-wave amplitude, pulse arterial tone, pulse transient oscillation amplitude, PTT arousal, surrogate or qualitative blood-pressure measures, sleep stage confidence levels or probability based on vascular tonicity and autonomic disturbances
  • the present invention provides a incorporates a gyro-meter system capable of determining an individual tilt or angular position with reference to gravity or horizon position as a measure of health (i.e. gait, Parkinson's onset, fall-detection) or a fitness (optimal performance motion, performance, behavioural physiological mechanics, efficiency, improvement etc.) as also further detailed in this document under health conditions or monitoring detail sub-headings.
  • a measure of health i.e. gait, Parkinson's onset, fall-detection
  • a fitness optimal performance motion, performance, behavioural physiological mechanics, efficiency, improvement etc.
  • Locational information based on GPS or derived from communications systems including (but not limited to) any of or any combination of CDMA/Code Division Multiple Access,
  • the present invention provides a position sensor system (such as "metal ball in switch cage device capable of determining an individual's posture at any time);
  • the present invention provides a incorporates a photo-plethysmography pulse sensor;
  • the present invention provides a incorporates as part of the body of ear-buds (such as wireless linked music or communication earphones) any sensors including (but not limited to) sensor for the monitoring of cardioballistogram (i.e. sensitive membrane sensor system such as accelerometer), temperature (i.e. thermistor, thermo-coupler, PVDF, infrared LDR, infrared LDR and interfaced infrared LED (including LED switching for 3-dimensional thermal-imaging characterisation or mapping capabilities) capable of deploying near-field energy heat characterisation associated with an individual's effort or energy exertion or related metabolism or calorie burning rate, as detailed elsewhere in this document).
  • cardioballistogram i.e. sensitive membrane sensor system such as accelerometer
  • temperature i.e. thermistor, thermo-coupler, PVDF, infrared LDR, infrared LDR and interfaced infrared LED (including LED switching for 3-dimensional thermal-imagin
  • the present invention provides a enables a means of signifying to an individual wearing ear- buds of precursors to health conditions or events of interest such as cardiac events or thresholds, whereupon automated auditory (which can override music or ongoing phone audio as warranted) in circumstances when respiratory rates or oxygen saturation, body-temperature or other factors potentially detrimental to safe and reasonable physiological conditions.
  • the present invention provides a enables a means of signifying to an individual wearing ear- buds of precursors to health or safety conditions including determination of rail-crossings, raids or detection of on-coming vehicles which otherwise may not be noticed due to reduced sensory perception related to factors such as phone calls or music, whereby the present invention can override music or ongoing phone audio as warranted in order to notify individual of pending or possibly pending danger.
  • Such processes or devices can be used in conjunction with glasses or other wearable or mobile camera or audio monitoring devices.
  • the present invention provides a wireless-linked stereo or mono ear-buds to incorporate health management systems capable of any combination of:
  • Integrated plethysmography oximeter with any information outputs including :
  • Electrophysiological sensor including any combination of : EEG sensor
  • EEG including vestibular detection
  • the present irwention provides PHONE-HOLDER of esent i vention- com ined one, entertainment health-traeksng and/or earing aid ear-buds or headphones
  • the present invention incorporates within earphone buds the capability of one or microphones in one or two subject-worn earphones whereby said microphones can measure environmental sounds including speech various orientations, and by way of analysing phase, amplitude level, spectral composition and comparative characteristics between two or more said microphones from earphones place in one or both subject's ears (as well as the option of other locations).
  • driving earphone speakers of interest can include driving a plurality of speakers in each earphone and collectively across both earphones in order to maximise spatial information for subject and/or speech audio focus and/or spectral filtering and/or background or unwanted background noise in accordance to subjects specific auditory hearing requirements as well as personalised audio options (i.e. speech focus, music enjoyment, speech tuning in crowded or noise environments, etc.).
  • the present invention further provides a means of augmenting conventional
  • Said invention can be calibrated and compensated for subject-specific hearing performance using online application or in specialised acoustic environment.
  • the present in ention provides EAR-BODS HEALTH MONITORING INCLUDE PA R HEA I G FUMCTlOn) of the present Inventi n -
  • the present invention describes wearable audio ear or headphone(s) method or devices incorporating health monitoring capability comprising one or more electrophysiological sensors (electrodes) capable of neural and/or myogenic monitoring capabilities.
  • the said neural monitoring can include monitoring electroencephalography (EEG) signals, via electrodes embedded or attached as part of earphone or headphone devices, including the capability to monitor EEG signals, in the cochlear or vestibular brain regions.
  • EEG monitoring can include the monitoring proximity head or scalp regions via additional wire connected electrodes.
  • the said myogenic monitoring can include monitoring post-auricular muscle responses (PAMR), via electrodes embedded or attached as part of earphone or headphone devices, including the capability to monitor electromyography (EMG) signals, in the cochlear or vestibular brain regions.
  • EMG monitoring can include the monitoring proximity head or scalp regions via additional wire connected electrodes.
  • PAMR post-auricular muscle response
  • the present invention records and analyses the post-auricular muscle response (PAMR) as a biometrics signal applicable to loud sound level responses and relevant to potentially regulating or minimising dangerous sound levels in children's or adults earphones or ear-buds or headphones and thus mitigate potential hearing damage otherwise applicable (especially to younger children with more sensitive auditory sensory systems).
  • the present invention further incorporates as part of a mobile or wireless mobile processing device or phone incorporating a series of audiology tests via an application software and audiology test paradigms.
  • Said "audiology tests” can comprise of any of or any combination of:
  • modified pure tones e.g., warble, pulsed

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