WO2008096307A1 - Sleep management - Google Patents
Sleep management Download PDFInfo
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- WO2008096307A1 WO2008096307A1 PCT/IB2008/050386 IB2008050386W WO2008096307A1 WO 2008096307 A1 WO2008096307 A1 WO 2008096307A1 IB 2008050386 W IB2008050386 W IB 2008050386W WO 2008096307 A1 WO2008096307 A1 WO 2008096307A1
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- sleep
- user
- sensors
- bed
- quality
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Definitions
- the invention is related to a system and a method for improving sleep quality.
- a sleep problem can affect everyone. More than 70 million people in the United States have a sleep disorder. Most of these people are unaware of it. Many of those who are aware of it never choose to seek help.
- the overnight course of sleep is not a linear process, but it exhibits a complex behavior, which involves the central nervous system at different levels at different times.
- PSG polysomnographic
- NREM non-rapid eye movement
- the daily shifts from the wake state to NREM and REM sleep are under the control of interconnected processes, including the circadian timing of sleep onset: the homeostatic balance between wakefulness and sleep; the ultradian interaction between NREM and REM sleep.
- Arousals are transient episodes of cerebral activation during sleep, which involves massively the cortex regulated by interplay between cortical and subcortical neurons. Arousals are considered as a transient cortical activation in responses to sleep disruptive events.
- EEG electroencephalographic
- K-complexes and delta bursts are associated with an analogous activation of vegetative and somatomotor functions.
- PSG Polysomnography
- Sleep quality does not only depend on one parameter such as total sleep time. Other relevant parameters are for example sleep efficiency (total sleep time versus time spent in bed), sleep onset latency, number and duration of night time awakenings, number of sleep cycles, percentage / duration of time spent in the respective sleep stages (e.g. slow wave sleep (SWS), REM sleep). Furthermore, personal preferences (morning type / evening type) and subjective perceptions play a role.
- Arousals are present during sleep in healthy subjects as well.
- PSG has also been the standard technique for quantifying the number of arousals during sleep and for providing an index of sleep fragmentation (number of arousals per hour of sleep).
- the number of arousals is, in fact, a useful marker of sleep quality and it is fundamental in the evaluation of insomnia as well as hypersomnia patients.
- Sleep quality evaluation by full polysomnography or ambulatory monitoring for sleep disorders are usually performed in hospitals or private sleep laboratories. In the last years especially screening of patients for sleep disordered breathing is more and more done at the patients' homes with ambulatory systems. A variety of different devices and products are on the market. The high cost of in- laboratory, full-night polysomnography, together with long waiting lists for sleep studies, have led to the development of a variety of ambulatory sleep study systems. PSG is relatively expensive and time-consuming, and its availability is limited in many areas. US 2005/0143617 Al, for example, describes a sleep system with sensors capable of correlating sleep quality data and environmental data. In the last years there has been a considerable progress in the development of portable monitoring devices for sleep disorders.
- a sleep management system comprising at least one sensor for monitoring one or more physiological parameters of a sleeping user, a processor unit for analysing data received from the at least one sensor, a user interaction device for receiving a feedback from the user which feedback in particular reflects a subjective perception of the user, and for providing information output to the user, wherein the processor unit is adapted to correlate the feedback and an objective quality of sleep of the user assessed from the data, and wherein the information output comprises a recommendation generated by the processor unit, to affect the behavior of the user in order to improve the objective quality of sleep of the user.
- the system according to the invention is applicable and beneficial for healthy users as well, as improved sleep quality leads to better performance during daytime.
- the physiological parameters which are measured are preferably one or more of heart rate, heart rate variability, breathing rate and activity.
- Typical information obtained from the sensed data is for example:
- the objective quality of sleep is preferably calculated on the basis of at least one of a sleep profile, sleep efficiency, sleep onset latency, number and duration of awakenings and number of sleep cycles per night, which can be determined from the physiological parameters.
- the objective quality of sleep is advantageously given as a sleep quality index which is preferably part of the information output of the system.
- the user may advantageously evaluate by themselves which factors have influence on their sleep quality.
- the recommendation preferably is to consult a physician.
- Sleep problems in general as well as sleep-disordered breathing (obstructive sleep apnea syndrome, OSAS) in particular, will preferably be addressed by the system according to the present invention, i.e. these sleep disorders are advantageously detectable by the system but have to be treated by professional healthcare personnel.
- OSAS sleep-disordered breathing
- the user will be recommended to a physician.
- the sensors of the inventive sleep management system are preferably unobtrusive. More preferred, the sensors are integrated into one or more of a bed foil, a textile bed electrode, sleeping clothing and bed posts. It is an advantage of these sensors that their use does not impede the sleep of the user. They are not experienced as uncomfortable or obtrusive. In particular, the sensors are integrated into the bed or into the nightwear.
- a bed foil sensor is for example an electret foil. In a suitable electret bed foil sensor, a voltage is caused by pressure changes. An advantageously good signal can be obtained when using a large area sensor (typically about 300 mm by 600 mm). It should be positioned in the thorax region of the user, preferably ending slightly below the ribcage.
- the foil can be integrated into the bed sheet, the mattress or the bedstead.
- a preferred sample rate is from about 250 samples per second up to 1 kHz. If the heart rate variability is not required the sample rate can also be significantly lower.
- heart rate variability By the electret foil heart rate, heart rate variability, breathing rate, activity and certain breathing patterns (OSA) can be deducted.
- a voltage is caused by changes in weight distribution on the bed.
- Sensors are integrated in the bed posts and/or in the bed frame.
- the preferred sample rate is equal to the electret bed foil.
- a textile bed electrode in the sense of the invention is in particular a pillow and/or foot mat electrode.
- the pillow and the foot mat electrode are preferably used as sensor for heart rate and heart rate variability detection during night if the signal quality from the bed foil, for example, is not sufficient.
- the pillow and the foot mat electrode are most preferably composed of conductive woven yarn.
- a large electrode is positioned preferably in the foot area and another large area electrode in the head area.
- the sample rate is preferably about 250 samples per second.
- Sleeping clothing sensors includes vests, bra, night gown and pajama, preferably with zipper, comprise integrated electrodes. These devices may advantageously be used as an alternative to the bed sheet approach. They are part of a preferred embodiment, when also measurements during day are required, where wearable sensors are part of the concept anyhow. These may advantageously be used in conjunction with dedicated electronics described below. Sleeping clothing sensors provide preferably a 1-lead ECG signal from textile electrodes, advantageously positioned in the user's chest area. The preferred sample rate is about 250 samples per second, measuring heart rate and heart rate variability. In a further preferred embodiment of a sleeping clothing sensor, a respiration signal (frequency /amplitude) is provided by a electret-resistive textile in a thoracic position.
- the preferred sample rate is about 25 samples per second.
- an activity detection is provided by a 3D-accelerometer signals at a sample rate of about 25 samples per second.
- a single sensor like the bed foil or a bed post sensor, can be used to detect, for example, movements caused by activity of the sleeping user, in particular caused by breathing and by heart movements.
- information like breathing rate, activity level, heart rate and even heart rate variability can be deduced from this one sensor.
- the accuracy of the measurements is advantageously increased if combinations of these sensors are used, like for example, a bed foil in combination with textile electrodes for ECG measurements.
- the sensors switch on and off automatically.
- the sensors can start the measurement of the vital body signs automatically without specific user interaction by going to bed or - in the case of textile nightwear - by dressing for bed.
- the system according to the present invention comprises a relay, which provides data acquisition channels for the transfer of data from the sensors to the processor unit.
- the relay preferably comprises at least a first hub for bed-integrated sensors and a second hub for wearable sensors.
- no user interaction is required for the relay function. The relay detects when the user enters the bed or puts on the wearable clothing sensors, and starts and stops the measurement automatically.
- the first hub for the bed-integrated sensors preferably collects the signals from the electret foil, the pillow and foot mat electrode (Textile ECG) and transmits the heart rate signal (from ECG and electret), respiration (rate, amplitude, from electret), activity level (from electret).
- the first hub is preferably positioned under the bed.
- the first hub is preferably supplied via a mains plug, possibly with rechargeable back-up batteries.
- the second hub for wearable clothing sensors provides acquisition channels for one or more of the signals: ECG, respiration and activity accelerometer signal. Besides the data signals, the first and second hub may as well process the following signals: lead-on detection (auto-on), lead-off detection (auto-off) and signal quality check.
- the second hub preferably comprises a rechargeable battery as power supply, with a lifetime of, for example, at least seven days. Recharging may be performed by a plugged external charger or contact less charging.
- the first and second hub both preferably comprise a memory, which advantageously stores raw data of five previous sessions, for later transmission to the processor unit. Raw data might also be beneficial for coaching by professionals.
- the first and second hub preferably comprise wired links to the sensors and wireless communication with the processor unit and/or the user interaction device. Upon preferably automatic establishment of a connection between the first and/or second hub and the processor unit, the stored data is automatically downloaded to the processor unit.
- the second hub is preferably miniaturized. The height is preferably less than 2 cm. Furthermore preferred, it is water- resistant and soft-packaged.
- the system further comprises a data storage for storing the sleep profiles, the processor unit being adapted to compare an actual sleep profile to stored sleep profiles of the user and/or to a standard sleep profile.
- a possible deviation in the user's sleep profile from their long time profile may advantageously be detected.
- a cause of a sleep disturbance may be detected more precisely.
- the user interaction device is a portable device with a screen and at least one input means.
- the objective sleep quality as assessed by the system is advantageously available to the user via the interaction device.
- a portable device with large LCD screen is advantageous.
- a level of processing power, storage and display resources preferably allows to run a sleep management software.
- the user interaction device preferably provides a touch-screen or button menus.
- the user interaction device preferably provides at least Bluetooth and/or LAN for communication.
- the user interaction device provides for multimode feedback methods, including one or more of text format, graphics, color coded, audio, video and speech.
- Active user input is advantageously possible, for example to fill in questionnaires about the subjective evaluation of the user's sleep.
- Use of the user interaction device is advantageously simple, as a variety of standard actions is preferably addressable in a one button manner.
- the user interaction device and the processor unit may either be combined in one package, for example a computer or handheld device, or the user interaction device and the processor unit are separated.
- a preferred feature of the system and the method according to the invention is a software used for the extraction of the information to a level that can be fed back to the user.
- the raw signal is filtered, characteristic features, e.g. R-peaks, pulse or breathing cycles are extracted, R-R intervals or pulse-pulse intervals are calculated and the heart rate variability or pulse rate variability are analyzed.
- the sleep profile is calculated and the sleep quality is evaluated.
- the output comprises the sleep profile as a so-called simplified hypnogram and the sleep fragmentation computation (number of micro arousals per hour of sleep).
- the simplified hypnogram describes the states of being awake, light sleep, deep sleep and REM sleep.
- the sleep quality will be scored on basis of sleep efficiency, sleep onset latency, number and duration of awakenings, and the number of sleep cycles during the night.
- the actual sleep profile may advantageously be compared to a typical sleep profile of a healthy person or a standard sleep profile, but also in comparison to a formerly recorded typical sleep profile of the actual individual in order to evaluate changes and trends.
- personalized feedback will be given about these parameters based on age-specific reference parameters.
- sleep apnea events are advantageously detected. This can be achieved by the heart rate variability analysis.
- the user's feedback is input into the system via the user interaction device.
- the user's feedback comprises, for example, their subjective assessment of the sleep quality.
- the user fills in questionnaires via the user interaction device. For example, specific sleep hygiene recommendations will be offered based on overnight measurements and information derived from the questionnaires, for example morning and evening questionnaires based on sleep logs and/or sleep diaries used by sleep specialists.
- the goal in sleep management is to increase sleep quality which involves sometimes also sleep quantity.
- the recommendation will be offered for implementing sleep hygiene measures, for example increasing daytime activity levels and/or reducing other factors that can have an impact on sleep quality, e.g. reducing alcohol or caffeine intake.
- the recommendation comprises one or more of the following: - setting a regular daytime for sleep and/or reminding the user of the regular daytime for sleep, adapting an activity level of the user during daytime, reducing sleep impeding factors, like caffeine intake, heavy evening meals, refraining from napping during daytime, - developing sleep rituals, for example relaxation exercises before going to bed regularly practicing relaxation techniques using psychological strategies as learned from cognitive behavioral therapy restricting sleep time
- strategies from cognitive behavioral therapy are implemented preferably, which enable the user to cope, with the implications of e.g. insomnia and arousals at night on a psychological level.
- a compliance of the user with the recommendations is assessable by the monitored parameters and/or by the feedback.
- the system preferably supports the user, for example with the following coaching measures: Monitoring sleep times and assessing sleep quality. If necessary and wanted by the user, reminders for getting to sleep or other recommendations for increasing sleep quality will be shown.
- the sleep quality may advantageously be increased, over a period of, for example, several weeks.
- the system according to the present invention preferably provides the option to send the user's data on sleep quality and/or trends to a medical call center, for example, to get personal advice by professionals.
- Another objective of the present invention is a method for managing sleep, using a system according to the present invention, wherein the behavior of the user is affected by coaching the user, according to a coaching strategy which is adapted to individual preferences of the user.
- inventive sleep management method is advantageously high, as the user is, to a large extent, actively involved, for example by defining goals and also in the selection of a suitable motivating strategy.
- inventive sleep management method is thus advantageously suitable for different types of users.
- the method preferably comprises an initialization step at the beginning of the coaching, wherein user characteristics and preferences are fed into the system. More preferable, the input of the initialization step is reviewed regularly in a recurring update loop.
- the coaching of the user preferably comprises behavioral recommendations to the user. More preferable, a compliance of the user with the behavioral recommendations is checked in at least one recurring check loop. The recommendation is preferably adjusted according to the user's compliance.
- the method implies, for example, that parameters used to optimize the sleep management method are checked on different time scale. For example, there are fixed parameters like user name, birthday and so on. Certain preferences or environmental factors vary slowly, e.g. a subjective evaluation of the work stress or family situation should be given approximately every month. Other parameters should be measured or evaluated daily - as long as the user does not feel annoyed by it.
- the coaching strategy is preferably adapted according to the results of a number of previous check loops. Furthermore preferred, the user's sleep quality is evaluated, in particular according to one or more of the parameters sleep efficiency, sleep onset latency, number and duration of awakenings and number of sleep cycles per night, and the coaching strategy is preferably also adapted according to the evaluation of the sleep profile and/or sleep quality and/or trends in these parameters.
- the system and method according to the invention can be part of an overall system related to managing car dio -vascular risk in healthy persons and/or as a stand-alone system and method for sleep management.
- Figure 1 schematically illustrates a sleep management system, according to the present invention.
- Figure 2 shows a flow diagram which illustrates a coaching strategy, according to the inventive method for sleep management.
- Figure 3 shows a flow diagram which illustrates compliance checks, according to the inventive method for sleep management
- a sleep management system according to the present invention, is schematically illustrated.
- Bed post sensors 2, a bed foil sensor 3 and two or more textile bed electrodes 4 are integrated into a bed of a user.
- the bed post sensors 2, the bed foil sensor 3 and the textile bed electrodes 4 are connected via data acquisition channels 9 to a relay 6.
- the data signals measured by the sensors 1, 2, 3, 4, 5 are one or more of a heart rate, heart rate variability, breathing rate and activity (movement/acceleration).
- the processed data is fed to a processor unit 10, preferably by wireless communication.
- the processed data is output as a sleep profile or simplified hypnogram and/or a sleep fragmentation index, via a user interaction device 11 on a screen 12.
- the processed data is also stored on a data storage 14 for comparison and/or later use.
- the user interaction device 11 comprises input means 13 to receive a feedback by the user, the processor unit 10 being adapted to correlate the objective quality of sleep as assessed via the sensors 1, 2, 3, 4, 5 and the user feedback.
- the processor unit 10 generates recommendations to affect the behavior of the user in order to improve the objective sleep quality.
- the processor unit 10 and the user interaction device 11 may as well be one integrated device.
- a setup phase 100 represents an initial operation of the inventive sleep management system, comprising a calibration step 101, where an initial characterization of the relevant user characteristics and preferences is made.
- a software guides the user through goal setting and assignment in a status monitoring phase 110. Based on these individual settings the continuous monitoring improvement program 120 starts.
- the status monitoring phase 110 there will be checks 111 on the actual health status of the user; problem areas will be defined (step 112) and improvement programs will be proposed (step 113).
- the recurring loop 114 illustrates the user feedback. The system will only resume if the user accepts a proposed improvement program 120.
- goals will be set (step 121), according to the individual preferences of the user. For example, goals may be oriented towards improved performance of the user or oriented towards changes in behavior of the user.
- Daily assignments will be made (step 122) and can be controlled by monitoring a compliance and/or motivation (step 123) and/or by monitoring a progress (step 124) of the user, e.g. by questionnaires via the user interaction device or by the applied sensors (see Figure 1). For example, the assignment "Not to drink more than three cups of coffee today" is preferably checked by a questionnaire in the evening. The assignment "Have a walk in the afternoon” is preferably checked by sensors, as for example a clip-on accelerometer. The daily assignments are adjusted as necessary (step 125).
- step 126 Additional motivational mechanisms may be used (step 126), if necessary.
- the goal setting preferably takes into account the actual behavior of the user and adjusts the goal if necessary (step 127).
- a user exhibiting a sedentary lifestyle may be recommended to do a daily walk for improvement of sleep quality, while for the same purpose an active sportsman may be recommended to not have exercises in the evening hours. If the goal is reached (step 129) or the actual improvement program 120 is stopped by the user (step 128), the system will return to the status monitoring phase 110.
- FIG 3 a flow diagram which illustrates compliance checks, according to the inventive method for sleep management, is shown.
- the compliance of the user is another parameter that will be continuously monitored (steps 140, 141) by checking the daily assignments. If the daily assignments are not reached (step 142), the daily assignments or the overall goal may be adapted (step 143) for any reason. If not, a compliance problem may have occurred (step 144) and countermeasures can be taken (step 145), in form of changing motivational patterns (step 146), or asking for additional feedback and changing daily assignments (step 147).
Abstract
Sleep management system and method for improving sleep quality. The system preferably consists of unobtrusive sensors (1, 2, 3, 4, 5) which allow a continuous, every night monitoring, without interfering with a user's sleep. They aresuited to record a certain set ofvital parameters that allows for basic characterization of sleep quality. The user.preferably receives daily feedback on sleep scores and suggestions to improve sleep 5 quality based on medically accepted behavioral changes. The system and method use data processing software, feedback and coaching strategies.
Description
Sleep Management
The invention is related to a system and a method for improving sleep quality.
A sleep problem can affect everyone. More than 70 million people in the United States have a sleep disorder. Most of these people are unaware of it. Many of those who are aware of it never choose to seek help. The overnight course of sleep is not a linear process, but it exhibits a complex behavior, which involves the central nervous system at different levels at different times. During sleep, several states of vigilance are classified on the basis of conventional polysomnographic (PSG) measures: four non-rapid eye movement (NREM) stages and one REM stage. The daily shifts from the wake state to NREM and REM sleep are under the control of interconnected processes, including the circadian timing of sleep onset: the homeostatic balance between wakefulness and sleep; the ultradian interaction between NREM and REM sleep. More recently, especially to explain the clinical consequences of sleep disorders, the three processes of sleep regulation - circadian, homeostatic and ultradian - have been integrated by the definition of the arousal system. Arousals are transient episodes of cerebral activation during sleep, which involves massively the cortex regulated by interplay between cortical and subcortical neurons. Arousals are considered as a transient cortical activation in responses to sleep disruptive events. However, other studies indicate that arousals punctuate both REM and NREM sleep even in the absence of detectable disturbing stimuli. Besides the conventional arousals other electroencephalographic (EEG) patterns, such as K-complexes and delta bursts, are associated with an analogous activation of vegetative and somatomotor functions.
Polysomnography (PSG) is widely accepted as the "gold standard" for the diagnosis of sleep disorders. Parameters that are measured with PSG include: electroencephalogram (EEG), electrooculogram (EOG), electromyogram (EMG),
electrocardiogram (ECG), respiration (flow, chest, abdomen), oxygen saturation and snoring sounds.
Sleep quality does not only depend on one parameter such as total sleep time. Other relevant parameters are for example sleep efficiency (total sleep time versus time spent in bed), sleep onset latency, number and duration of night time awakenings, number of sleep cycles, percentage / duration of time spent in the respective sleep stages (e.g. slow wave sleep (SWS), REM sleep). Furthermore, personal preferences (morning type / evening type) and subjective perceptions play a role.
Arousals are present during sleep in healthy subjects as well. PSG has also been the standard technique for quantifying the number of arousals during sleep and for providing an index of sleep fragmentation (number of arousals per hour of sleep). The number of arousals is, in fact, a useful marker of sleep quality and it is fundamental in the evaluation of insomnia as well as hypersomnia patients.
Sleep quality evaluation by full polysomnography or ambulatory monitoring for sleep disorders are usually performed in hospitals or private sleep laboratories. In the last years especially screening of patients for sleep disordered breathing is more and more done at the patients' homes with ambulatory systems. A variety of different devices and products are on the market. The high cost of in- laboratory, full-night polysomnography, together with long waiting lists for sleep studies, have led to the development of a variety of ambulatory sleep study systems. PSG is relatively expensive and time-consuming, and its availability is limited in many areas. US 2005/0143617 Al, for example, describes a sleep system with sensors capable of correlating sleep quality data and environmental data. In the last years there has been a considerable progress in the development of portable monitoring devices for sleep disorders.
It is a drawback of existing techniques, which have adequate sensitivity and specificity for diagnosing sleep disorders, that these are usually uncomfortable, as well as being costly and requiring specialist personnel and expensive infrastructure.
It is therefore an objective of the invention to provide a cost-effective and reliable sleep quality diagnostic and screening that can be applied on a daily/nightly basis and which can be used by any consumer without special education or professional support.
The above objective is accomplished by a sleep management system, the sleep management system comprising at least one sensor for monitoring one or more physiological parameters of a sleeping user, a processor unit for analysing data received from the at least one sensor, a user interaction device for receiving a feedback from the user which feedback in particular reflects a subjective perception of the user, and for providing information output to the user, wherein the processor unit is adapted to correlate the feedback and an objective quality of sleep of the user assessed from the data, and wherein the information output comprises a recommendation generated by the processor unit, to affect the behavior of the user in order to improve the objective quality of sleep of the user.
It is an advantage of the system according to the invention that the user learns on their sleep quality and receives recommendations related to their everyday behavior in layman's terms by the information output which can help to improve their sleep quality. The system according to the present invention is applicable and beneficial for healthy users as well, as improved sleep quality leads to better performance during daytime. The physiological parameters which are measured are preferably one or more of heart rate, heart rate variability, breathing rate and activity. Typical information obtained from the sensed data is for example:
time spent in bed total sleep time - sleep architecture / sleep profile
percentage of and duration in minutes of respective sleep stages (REM, light sleep, SWS) number of awakenings wake time - sleep onset latency sleep fragmentation (number of (micro-) arousals per hour) sleep apnea events
The objective quality of sleep is preferably calculated on the basis of at least one of a sleep profile, sleep efficiency, sleep onset latency, number and duration of awakenings and number of sleep cycles per night, which can be determined from the physiological parameters. The objective quality of sleep is advantageously given as a sleep quality index which is preferably part of the information output of the system. The user may advantageously evaluate by themselves which factors have influence on their sleep quality.
Upon detection of serious medical conditions during the sleep of the user, however, the recommendation preferably is to consult a physician. Sleep problems in general as well as sleep-disordered breathing (obstructive sleep apnea syndrome, OSAS) in particular, will preferably be addressed by the system according to the present invention, i.e. these sleep disorders are advantageously detectable by the system but have to be treated by professional healthcare personnel. Thus, in case of serious medical conditions causing or accompanying the sleep disturbances (such as OSAS or depression), the user will be recommended to a physician.
The sensors of the inventive sleep management system are preferably unobtrusive. More preferred, the sensors are integrated into one or more of a bed foil, a textile bed electrode, sleeping clothing and bed posts. It is an advantage of these sensors that their use does not impede the sleep of the user. They are not experienced as uncomfortable or obtrusive. In particular, the sensors are integrated into the bed or into the nightwear. A bed foil sensor is for example an electret foil. In a suitable electret bed
foil sensor, a voltage is caused by pressure changes. An advantageously good signal can be obtained when using a large area sensor (typically about 300 mm by 600 mm). It should be positioned in the thorax region of the user, preferably ending slightly below the ribcage. Ideally, the foil can be integrated into the bed sheet, the mattress or the bedstead. A preferred sample rate is from about 250 samples per second up to 1 kHz. If the heart rate variability is not required the sample rate can also be significantly lower. By the electret foil heart rate, heart rate variability, breathing rate, activity and certain breathing patterns (OSA) can be deducted.
In a bed post sensor, a voltage is caused by changes in weight distribution on the bed. Sensors are integrated in the bed posts and/or in the bed frame. The preferred sample rate is equal to the electret bed foil. Again, heart rate, heart rate variability, breathing rate, activity and certain breathing patterns (OSA) can be deduced.
A textile bed electrode in the sense of the invention is in particular a pillow and/or foot mat electrode. The pillow and the foot mat electrode are preferably used as sensor for heart rate and heart rate variability detection during night if the signal quality from the bed foil, for example, is not sufficient. The pillow and the foot mat electrode are most preferably composed of conductive woven yarn. A large electrode is positioned preferably in the foot area and another large area electrode in the head area. The sample rate is preferably about 250 samples per second.
Sleeping clothing sensors includes vests, bra, night gown and pajama, preferably with zipper, comprise integrated electrodes. These devices may advantageously be used as an alternative to the bed sheet approach. They are part of a preferred embodiment, when also measurements during day are required, where wearable sensors are part of the concept anyhow. These may advantageously be used in conjunction with dedicated electronics described below. Sleeping clothing sensors provide preferably a 1-lead ECG signal from textile electrodes, advantageously positioned in the user's chest area. The preferred sample rate is about 250 samples per second, measuring heart rate and heart rate variability. In a further preferred embodiment of a sleeping clothing sensor, a respiration signal (frequency /amplitude) is provided by a
electret-resistive textile in a thoracic position. The preferred sample rate is about 25 samples per second. In a further preferred embodiment of a sleeping clothing sensor, an activity detection is provided by a 3D-accelerometer signals at a sample rate of about 25 samples per second. In principle, a single sensor, like the bed foil or a bed post sensor, can be used to detect, for example, movements caused by activity of the sleeping user, in particular caused by breathing and by heart movements. Using appropriate signal processing methods, information like breathing rate, activity level, heart rate and even heart rate variability can be deduced from this one sensor. The accuracy of the measurements is advantageously increased if combinations of these sensors are used, like for example, a bed foil in combination with textile electrodes for ECG measurements.
In a preferred embodiment, the sensors switch on and off automatically. For example, the sensors can start the measurement of the vital body signs automatically without specific user interaction by going to bed or - in the case of textile nightwear - by dressing for bed.
Preferably the system according to the present invention comprises a relay, which provides data acquisition channels for the transfer of data from the sensors to the processor unit. In case, that wearable clothing sensors and bed integrated sensors are used, the relay preferably comprises at least a first hub for bed-integrated sensors and a second hub for wearable sensors. Advantageously, no user interaction is required for the relay function. The relay detects when the user enters the bed or puts on the wearable clothing sensors, and starts and stops the measurement automatically.
The first hub for the bed-integrated sensors preferably collects the signals from the electret foil, the pillow and foot mat electrode (Textile ECG) and transmits the heart rate signal (from ECG and electret), respiration (rate, amplitude, from electret), activity level (from electret). The first hub is preferably positioned under the bed. The first hub is preferably supplied via a mains plug, possibly with rechargeable back-up batteries. The second hub for wearable clothing sensors provides acquisition channels for one or more of the signals: ECG, respiration and activity accelerometer
signal. Besides the data signals, the first and second hub may as well process the following signals: lead-on detection (auto-on), lead-off detection (auto-off) and signal quality check. The second hub preferably comprises a rechargeable battery as power supply, with a lifetime of, for example, at least seven days. Recharging may be performed by a plugged external charger or contact less charging. The first and second hub both preferably comprise a memory, which advantageously stores raw data of five previous sessions, for later transmission to the processor unit. Raw data might also be beneficial for coaching by professionals. The first and second hub preferably comprise wired links to the sensors and wireless communication with the processor unit and/or the user interaction device. Upon preferably automatic establishment of a connection between the first and/or second hub and the processor unit, the stored data is automatically downloaded to the processor unit. The second hub is preferably miniaturized. The height is preferably less than 2 cm. Furthermore preferred, it is water- resistant and soft-packaged.
In a preferred embodiment, the system further comprises a data storage for storing the sleep profiles, the processor unit being adapted to compare an actual sleep profile to stored sleep profiles of the user and/or to a standard sleep profile. A possible deviation in the user's sleep profile from their long time profile may advantageously be detected. Thus a cause of a sleep disturbance may be detected more precisely.
The user interaction device is a portable device with a screen and at least one input means. The objective sleep quality as assessed by the system is advantageously available to the user via the interaction device. For the user interaction (e.g. information, feedback and coaching) a portable device with large LCD screen is advantageous. A level of processing power, storage and display resources preferably allows to run a sleep management software. The user interaction device preferably provides a touch-screen or button menus. The user interaction device preferably provides at least Bluetooth and/or LAN for communication. In a preferred embodiment, the user interaction device provides for multimode feedback methods, including one or more of text format,
graphics, color coded, audio, video and speech. Active user input is advantageously possible, for example to fill in questionnaires about the subjective evaluation of the user's sleep. Use of the user interaction device is advantageously simple, as a variety of standard actions is preferably addressable in a one button manner.
The user interaction device and the processor unit may either be combined in one package, for example a computer or handheld device, or the user interaction device and the processor unit are separated.
A preferred feature of the system and the method according to the invention, is a software used for the extraction of the information to a level that can be fed back to the user. According to the sequence of analysis, the raw signal is filtered, characteristic features, e.g. R-peaks, pulse or breathing cycles are extracted, R-R intervals or pulse-pulse intervals are calculated and the heart rate variability or pulse rate variability are analyzed. The sleep profile is calculated and the sleep quality is evaluated. The output comprises the sleep profile as a so-called simplified hypnogram and the sleep fragmentation computation (number of micro arousals per hour of sleep). The simplified hypnogram describes the states of being awake, light sleep, deep sleep and REM sleep. The sleep quality will be scored on basis of sleep efficiency, sleep onset latency, number and duration of awakenings, and the number of sleep cycles during the night. The actual sleep profile, as mentioned before, may advantageously be compared to a typical sleep profile of a healthy person or a standard sleep profile, but also in comparison to a formerly recorded typical sleep profile of the actual individual in order to evaluate changes and trends. Preferably, personalized feedback will be given about these parameters based on age-specific reference parameters. Moreover, sleep apnea events are advantageously detected. This can be achieved by the heart rate variability analysis. An advantageously higher sensitivity and specificity is achieved selecting a set of relevant features from the R-R interval sequence and feeding them into appropriate classifier or by a standard pattern recognition approach with supervised learning (e.g.) in combination with respiration data (e.g. from the foil sensor or bedpost sensors).
Further, the user's feedback is input into the system via the user interaction device. The user's feedback comprises, for example, their subjective assessment of the sleep quality. Preferably, the user fills in questionnaires via the user interaction device. For example, specific sleep hygiene recommendations will be offered based on overnight measurements and information derived from the questionnaires, for example morning and evening questionnaires based on sleep logs and/or sleep diaries used by sleep specialists. The goal in sleep management is to increase sleep quality which involves sometimes also sleep quantity. A number of actions can be taken to increase sleep quality. By the inventive sleep management system, the recommendation will be offered for implementing sleep hygiene measures, for example increasing daytime activity levels and/or reducing other factors that can have an impact on sleep quality, e.g. reducing alcohol or caffeine intake.
Preferably, the recommendation comprises one or more of the following: - setting a regular daytime for sleep and/or reminding the user of the regular daytime for sleep, adapting an activity level of the user during daytime, reducing sleep impeding factors, like caffeine intake, heavy evening meals, refraining from napping during daytime, - developing sleep rituals, for example relaxation exercises before going to bed regularly practicing relaxation techniques using psychological strategies as learned from cognitive behavioral therapy restricting sleep time
Additionally, strategies from cognitive behavioral therapy are implemented preferably, which enable the user to cope, with the implications of e.g. insomnia and arousals at night on a psychological level.
More preferably, a compliance of the user with the recommendations is assessable by the monitored parameters and/or by the feedback. The system preferably supports the user, for example with the following coaching measures:
Monitoring sleep times and assessing sleep quality. If necessary and wanted by the user, reminders for getting to sleep or other recommendations for increasing sleep quality will be shown.
Monitoring the activity level during daytime and if necessary suggesting good times and ideas for doing exercises.
In regular intervals test other sleep quality influencing factors by means of a questionnaire. If necessary regular reminders will be shown for lowering these factors, e.g. lowering alcohol intake.
By coaching the user with these issues, the sleep quality may advantageously be increased, over a period of, for example, several weeks. The system according to the present invention preferably provides the option to send the user's data on sleep quality and/or trends to a medical call center, for example, to get personal advice by professionals.
Another objective of the present invention is a method for managing sleep, using a system according to the present invention, wherein the behavior of the user is affected by coaching the user, according to a coaching strategy which is adapted to individual preferences of the user.
The attractiveness of the inventive sleep management method is advantageously high, as the user is, to a large extent, actively involved, for example by defining goals and also in the selection of a suitable motivating strategy. The inventive sleep management method is thus advantageously suitable for different types of users.
The method preferably comprises an initialization step at the beginning of the coaching, wherein user characteristics and preferences are fed into the system. More preferable, the input of the initialization step is reviewed regularly in a recurring update loop.
The coaching of the user preferably comprises behavioral recommendations to the user. More preferable, a compliance of the user with the behavioral recommendations is checked in at least one recurring check loop. The
recommendation is preferably adjusted according to the user's compliance.
The method implies, for example, that parameters used to optimize the sleep management method are checked on different time scale. For example, there are fixed parameters like user name, birthday and so on. Certain preferences or environmental factors vary slowly, e.g. a subjective evaluation of the work stress or family situation should be given approximately every month. Other parameters should be measured or evaluated daily - as long as the user does not feel annoyed by it.
The coaching strategy is preferably adapted according to the results of a number of previous check loops. Furthermore preferred, the user's sleep quality is evaluated, in particular according to one or more of the parameters sleep efficiency, sleep onset latency, number and duration of awakenings and number of sleep cycles per night, and the coaching strategy is preferably also adapted according to the evaluation of the sleep profile and/or sleep quality and/or trends in these parameters.
The system and method according to the invention can be part of an overall system related to managing car dio -vascular risk in healthy persons and/or as a stand-alone system and method for sleep management.
These and other characteristics, features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention. The description is given for the sake of example only, without limiting the scope of the invention. The reference figures quoted below refer to the attached drawings:
Figure 1 schematically illustrates a sleep management system, according to the present invention. Figure 2 shows a flow diagram which illustrates a coaching strategy, according to the inventive method for sleep management.
Figure 3 shows a flow diagram which illustrates compliance checks, according to the inventive method for sleep management
The present invention will be described with respect to particular embodiments and with reference to certain drawings but the invention is not limited thereto but only by the claims. The drawings described are only schematic and are non- limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn true to scale for illustrative purposes.
Where an indefinite or definite article is used when referring to a singular noun, e.g. "a", "an", "the", this includes a plural of that noun unless something else is specifically stated.
Furthermore, the terms first, second, third and the like in the description and in the claims are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.
Moreover, the terms top, bottom, over, under and the like in the description and the claims are used for descriptive purposes and not necessarily for describing relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other orientations than described or illustrated herein.
It is to be noticed that the term "comprising", used in the present description and claims, should not be interpreted as being restricted to the means listed thereafter; it does not exclude other elements or steps. Thus, the scope of the expression "a device comprising means A and B" should not be limited to devices consisting only of components A and B. It means that with respect to the present invention, the only relevant components of the device are A and B. In Figure 1, a sleep management system, according to the present invention, is schematically illustrated. Bed post sensors 2, a bed foil sensor 3 and two or
more textile bed electrodes 4 are integrated into a bed of a user. The bed post sensors 2, the bed foil sensor 3 and the textile bed electrodes 4 are connected via data acquisition channels 9 to a relay 6. For the sake of intelligibility, only one data acquisition channel has been marked with reference sign 9. Signals from the bed post sensors 2, the bed foil sensor 3 and the textile bed electrodes 4 are collected by a first hub 7, which is preferably located at the bed. A wearable clothing sensor 1 and a wearable sensor 5 on a strap are wearable by a person during night and, if desired, also during daytime. Signals from the wearable clothing sensor 1 and the wearable sensor 5 are transmitted via acquisition channels 9 to a second hub 8 of the relay 6. The second hub is preferably wearable, e.g. it is attached to the clothing as well. The data signals measured by the sensors 1, 2, 3, 4, 5 are one or more of a heart rate, heart rate variability, breathing rate and activity (movement/acceleration). These data signals are fed to a processor unit 10, preferably by wireless communication. The processed data is output as a sleep profile or simplified hypnogram and/or a sleep fragmentation index, via a user interaction device 11 on a screen 12. The processed data is also stored on a data storage 14 for comparison and/or later use. The user interaction device 11 comprises input means 13 to receive a feedback by the user, the processor unit 10 being adapted to correlate the objective quality of sleep as assessed via the sensors 1, 2, 3, 4, 5 and the user feedback. The processor unit 10 generates recommendations to affect the behavior of the user in order to improve the objective sleep quality. The processor unit 10 and the user interaction device 11 may as well be one integrated device.
In Figure 2, a flow diagram is shown which illustrates a coaching strategy, according to the inventive method for sleep management. User feedback and coaching is organized according to such a strategy. A setup phase 100 represents an initial operation of the inventive sleep management system, comprising a calibration step 101, where an initial characterization of the relevant user characteristics and preferences is made. A software guides the user through goal setting and assignment in a status monitoring phase 110. Based on these individual settings the continuous monitoring improvement program 120 starts.
In the status monitoring phase 110, there will be checks 111 on the actual health status of the user; problem areas will be defined (step 112) and improvement programs will be proposed (step 113). The recurring loop 114 illustrates the user feedback. The system will only resume if the user accepts a proposed improvement program 120. In the improvement program 120, goals will be set (step 121), according to the individual preferences of the user. For example, goals may be oriented towards improved performance of the user or oriented towards changes in behavior of the user. Daily assignments will be made (step 122) and can be controlled by monitoring a compliance and/or motivation (step 123) and/or by monitoring a progress (step 124) of the user, e.g. by questionnaires via the user interaction device or by the applied sensors (see Figure 1). For example, the assignment "Not to drink more than three cups of coffee today" is preferably checked by a questionnaire in the evening. The assignment "Have a walk in the afternoon" is preferably checked by sensors, as for example a clip-on accelerometer. The daily assignments are adjusted as necessary (step 125). Additional motivational mechanisms may be used (step 126), if necessary. Furthermore, the goal setting preferably takes into account the actual behavior of the user and adjusts the goal if necessary (step 127). A user exhibiting a sedentary lifestyle may be recommended to do a daily walk for improvement of sleep quality, while for the same purpose an active sportsman may be recommended to not have exercises in the evening hours. If the goal is reached (step 129) or the actual improvement program 120 is stopped by the user (step 128), the system will return to the status monitoring phase 110.
In Figure 3, a flow diagram which illustrates compliance checks, according to the inventive method for sleep management, is shown. The compliance of the user is another parameter that will be continuously monitored (steps 140, 141) by checking the daily assignments. If the daily assignments are not reached (step 142), the daily assignments or the overall goal may be adapted (step 143) for any reason. If not, a compliance problem may have occurred (step 144) and countermeasures can be taken (step 145), in form of changing motivational patterns (step 146), or asking for additional
feedback and changing daily assignments (step 147).
As a fall back scenario human interaction via a call center should be taken into account. If the data measured during nights suggest, that the underlying problem of a sleep disturbance is a sleep apnea or a depressive episode, however, the recommendation will be to have this checked by professional personnel for a correct diagnosis.
Claims
1. Sleep management system comprising at least one sensor (1, 2, 3, 4, 5) for monitoring one or more physiological parameters of a sleeping user, a processor unit (10) for analysing data received from the at least one sensor, a user interaction device (11) for receiving feedback from the user and for providing information output to the user, wherein the processor unit (10) is adapted to correlate the subjective feedback and an objective quality of sleep of the user assessed from the data, and wherein the information output comprises a recommendation generated by the processor unit (10), to affect the behavior of the user in order to improve the objective quality of sleep of the user.
2. System according to claim 1, wherein the physiological parameters comprise one or more of a heart rate, heart rate variability, breathing rate and activity.
3. System according to claim 1, wherein the sensors (1, 2, 3, 4, 5) are unobtrusive.
4. System according to claim 1, wherein the sensors (1, 2, 3, 4, 5) are integrated into one or more of a bed foil (3), a textile bed electrode (4), sleeping clothing (1) and bed posts (2).
5. System according to claim 1, wherein the sensors (1, 2, 3, 4, 5) switch on and off automatically.
6. System according to claim 1, wherein a relay (6) provides data acquisition channels (9) for the transfer of data from the sensors (1, 2, 3, 4, 5) to the processor unit (10), the relay preferably comprising at least a first hub (7) for bed-integrated sensors (2, 3, 4) and a second hub (8) for wearable sensors (1, 5).
7. System according to claim 1, further comprising a data storage (14) for storing sleep profiles, the processor unit (10) being adapted to compare an actual sleep profile to stored sleep profiles of the user and/or to a standard sleep profile.
8. System according to claim 1, wherein the user interaction device (11) is a portable device with a screen (12) and at least one input means (13).
9. System according to claim 1, wherein the recommendation is to consult a physician upon detection of serious medical conditions during the sleep of the user.
10. System according to claim 1, wherein the recommendation comprises one or more of setting a regular daytime for sleep and/or reminding the user of the regular daytime for sleep, - adapting an activity level of the user during daytime, reducing sleep impeding factors, refraining from napping during daytime, developing sleep rituals regularly practicing relaxation techniques - using psychological strategies as learned from cognitive behavioral therapy restricting sleep time.
11. System according to claim 1, wherein a compliance of the user with the recommendations is assessable by the monitored parameters and/or by the feedback.
12. Method for managing sleep, using a system according to claim 1, wherein the behavior of the user is affected by coaching the user according to a coaching strategy which is adapted to individual preferences of the user.
13. Method according to claim 12, further comprising an initialization step at the beginning of the coaching, wherein user characteristics and preferences are input into the system.
14. Method according to claim 13, further comprising a recurring update loop, wherein the input of the initialization step is reviewed.
15. Method according to claim 12, wherein coaching of the user comprises behavioral recommendations to the user.
16. Method according to claim 15, further comprising a recurring check loop, wherein a compliance of the user with the behavioral recommendations is checked and wherein the assignment is adjusted according to the compliance.
17. Method according to claim 12, wherein the coaching strategy is adapted according to a number of previous check loops.
18. Method according to claim 12, wherein a user's sleep quality is evaluated, in particular according to one or more of the parameters sleep efficiency, sleep onset latency, number and duration of awakenings and number of sleep cycles per night, and wherein the coaching strategy is adapted according to the user's sleep profile and/or sleep quality and/or trends in the user's sleep profile and/or sleep quality.
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