Sleep aids and their controls

Abstract

Improved method for guiding a user to rhythmic breathing for sleep induction. A processing device controls the generation of a cyclically patterned user-perceivable stimulus to guide a user to rhythmically regulate their breathing. In some embodiments, a component is included for controlling the cyclic frequency of a first user-perceivable stimulus based on a physiological parameter determined from processing of a physiological sensor signal.

Description

Technical Field

[0001] The present invention relates to the field of sleep aids, such as sleep aids for assisting sleep induction. Background Art

[0002] One in three general adults reports symptoms of insomnia. It is a major public health problem and can lead to loss of concentration, memory and performance, as well as physical illness. Current drug treatments can be expensive, unhealthy and habit-inducing. Recent studies cited below show that individuals practicing slow-paced breathing while trying to fall asleep can help improve sleep onset and sleep quality. This has led to the development of products designed to stimulate individuals to follow a specific (slow) breathing rhythm. This concept is often called rhythmic breathing. There are various solutions that can help individuals breathe rhythmically, such as rhythmic breathing apps, rhythmic breathing videos and other means.

[0003] This new area of ​​development opens up new possibilities for further improvements and optimizations as well as new and improved solutions to general problems.

[0004] Reference: HJ Tsai, Efficacy of paced breathing for insomnia: enhances vagalactivity and improves sleep quality, Psychophysiology. 2015 Mar; 54(3): 388-96.

[0005] Reference: Sylvain Laborde, Influence of a 30-Day Slow-Paced BreathingIntervention Compared to Social Media Use on Subjective Sleep Quality and Cardiac Vagal Activity, J Clin Med. 2019 Feb; 8(2): 193.

[0006] US patent application US2015 / 0367097A1 discloses a system for sleep induction, including a monitor for analyzing a breathing pattern, and a stimulation generator for providing multiple stimulations to a user. US patent application US2022 / 0152340A1 discloses a tactile respiratory stimulator, which includes a pump unit and an accumulator for reducing noise from the pump action of the pump unit. European patent EP3606589B1 discloses a sleep induction device for inducing changes during a sleep period. The device includes a stimulator configured to provide stimulation to a user in anticipation of detected physiological characteristics. Summary of the invention

[0007] This disclosure summarizes a number of developments in the art of rhythmic breathing devised by the inventors to address one or more shortcomings of the prior art newly recognized by the inventors.

[0008] In current solutions, sensory stimulation with a rhythmic pattern of a specific frequency is usually generated, and the user is instructed to adjust his breathing rhythm to follow the rhythm of the stimulation. One disadvantage found by the inventor is that the phase of the guided stimulation may not match the breathing phase of the user. When the device is powered on and not aligned with the user's inhalation phase, the phase can usually be fixed. Therefore, the user needs to suddenly adjust his inhalation and exhalation phases to synchronize with the phase of the periodic stimulation, such as shortening the breath to start a new breath, or holding the breath for a longer time than it would be comfortable. This can cause the user to feel uncomfortable and nervous, and indeed triggers an involuntary physiological response of anxiety, which runs counter to the intended purpose of relaxing sleep. In addition, in some cases, the user can follow the sensory stimulation in the opposite phase. This does not cause problems with the stimulation cycle, which has a 1:1 inhalation and exhalation phase length, but when the inhalation and exhalation phase ratio is not 1:1, such as 1:2, the performance of rhythmic breathing will be reduced.

[0009] Another drawback of the prior art discovered by the inventors is that known solutions use standardized frequencies or frequency patterns for guided stimulation. However, the breathing rate that is most relevant for the onset of sleep actually varies from person to person and even for an individual over time. It is associated with certain physiological parameters of the user. Therefore, fixed frequency rhythmic breathing guidance is not optimal.

[0010] Another shortcoming in the current state of the art is that the specific sensory patterns currently used to deliver breathing guidance are somewhat inappropriate for the general purpose of inducing relaxation and sleep. For example, they often rely on periodic acoustic stimulation. However, in reality, these can cause dissonance and stress, and if maintained throughout sleep, can cause sleep disturbances. Therefore, a better way to deliver targeted breathing patterns would be valuable.

[0011] The following summarizes an overview of concepts devised by the inventors that are intended to address one or more of the above-identified deficiencies in the prior art.

[0012] The invention is defined by the claims.

[0013] According to a first aspect of the invention, there is provided a processing device for a sleep aid device, the sleep aid device comprising one or more stimulus generators operable to generate one or more user-perceivable stimuli having one or more sensory modalities, and the sleep aid device further comprising a physiological sensor. The processing device may be provided by itself for use with the sleep aid device, for example for controlling the sleep aid device. In addition, another aspect of the invention is a sleep aid device comprising the processing device. In addition, another aspect of the invention is a system comprising a sleep aid device and a processing device combined but separate, for example separate from a processing device embodied in a mobile computing device such as a smartphone. These options also apply to all other aspects of the invention.

[0014] The processing device is adapted to receive an input sensor signal from a physiological sensor.

[0015] The processing device is further adapted to control the generation (by one or more pairs of stimulus generators) of a first user-perceivable stimulus that is cyclically patterned to induce the user to match the rhythm of his breathing with the cyclic phase and cyclic frequency of the first user-perceivable stimulus. Cyclic patterning means, for example, cyclic patterning of the intensity of the associated stimulus.

[0016] In some embodiments, the processing device is adapted to control a cycle frequency of the first user-perceptible stimulus in dependence on a physiological parameter determined from processing of the physiological sensor signal.

[0017] In some embodiments, the processing device is adapted to control a cycle frequency of the first user-perceptible stimulus in dependence on a physiological parameter determined from processing of the physiological sensor signal.

[0018] In some embodiments, the processing device is further adapted to process the physiological sensor signal to determine a heart rate variability (HRV) amplitude of the user, and to set the frequency of the first user-perceivable stimulus in dependence thereon.

[0019] In some embodiments, the processing device is further adapted to implement a calibration procedure for setting a cycle frequency of the first user-perceptible stimulus, the calibration procedure comprising a series of epochs, and wherein:

[0020] The recurrence frequency of the first user-perceptible stimulus is set to a different respective value in each respective period;

[0021] During each epoch, the physiological sensor signals are processed to determine the user's HRV; and

[0022] The cycle frequency of the first user-perceptible stimulus is set during the calibration process equal to the cycle frequency consistent with the highest measured HRV.

[0023] In the art, this frequency that stimulates the highest measured HRV amplitude is sometimes called the HRV resonant frequency.

[0024] The HRV resonant frequency corresponds to a cyclic frequency of the first user-perceptible stimulus that coincides with a highest measured HRV measured during a plurality of epochs, the cyclic frequency of the first user-perceptible stimulus being set to a different value during each of the plurality of epochs.

[0025] Peak HRV is known to be associated with optimal states of inducing relaxation and sleep. It is therefore proposed to measure the breathing rhythm of the peak HRV of a particular user of the stimulation for the device, and then set the cyclic frequency of the first user-perceivable stimulation to match this rhythm. This can be achieved by directly measuring physiological parameters of the user from which the heart rate can be derived, and then using the heart rate signal to derive the HRV over a series of periods of varying stimulation frequency.

[0026] In some embodiments, the physiological sensor may be a PPG sensor.

[0027] In some embodiments, the processing device is adapted to monitor the breathing phase of the user based on processing of input sensor signals from the physiological sensor.

[0028] In some embodiments, the processing device is also adapted to configure the cycle phase of the first user-perceivable stimulation based on the user's breathing phase. The processing device can be adapted to configure the initial or starting cycle phase of the first user-perceivable stimulation based on the user's breathing phase, for example. For example, the processing device can be adapted to set the initial or starting cycle phase of the first user-perceivable stimulation to match the cycle phase of the user's breathing cycle. For example, the processing device can be adapted to perform a startup routine in which the user's breathing phase is monitored within one or more breathing cycles using a sensor signal from a physiological sensor. Thereafter, the generation of the first user-perceivable stimulation can be started so that at the beginning, the cycle phase of the first user-perceivable stimulation matches the breathing phase of the user.

[0029] Additionally or alternatively, in some embodiments, the processing device is further adapted to determine a synchronization state between the cycle phase of the first user-perceivable stimulus and the user's breathing phase. The synchronization state represents, for example, an indication of the degree of phase alignment between the cycle phase of the first user-perceivable stimulus and the user's breathing phase.

[0030] In some embodiments, the processing device is further adapted to perform a response action based on the synchronization state.In some embodiments, the response action is to improve / increase the synchronization between the cycle phase of the first user-perceptible stimulus and the user's breathing phase.

[0031] By determining the degree of synchronization between the phase of the rhythmic breathing guided stimulation and the current phase of the user's breathing, steps can be taken to help reduce any misalignment therebetween. This therefore helps alleviate the above-mentioned problem (where the user experiences anxiety and stress due to a mismatch between their current breathing phase and the stimulation phase).

[0032] It should be noted that there is a distinction between stimulation frequency and stimulation phase. In fact, a user's breathing rate can be perfectly matched to the lead stimulation frequency, but their breathing is inconsistent with the stimulation. This can trigger a stress response and is not conducive to the relaxation state required for sleep. Therefore, it is valuable to provide a solution that can help improve the phase difference, even if it is completely independent of any control or adjustment of the basic frequency or period of the first user-perceivable stimulation (although solutions to address frequency issues are also proposed further below and can be combined with phase-related solutions).

[0033] It should also be noted that in the context of the present disclosure, the terms breathing cycle and respiration cycle are used synonymously. Therefore, references to respiration phases or frequencies and references to breathing phases or frequencies can be considered references to the same thing.

[0034] It should also be noted that in the context of the present disclosure, the terms cycle frequency and cycle period as applied with respect to the first user-perceivable stimulus refer to the frequency of repetition of each cycle of the cyclic pattern embodied by the first user-perceivable stimulus. This can be a smooth sinusoidal pattern or a pattern of a different shape, for example, tilted to induce a longer exhalation than an inhalation. For example, each cycle of the cyclically patterned first user-perceivable stimulus may include an inhalation phase portion and an exhalation phase portion, and the durations of the inhalation phase portion and the exhalation phase portion may be different from each other. In other words, the ratio between the duration of the inhalation phase portion and the exhalation phase portion may not be 1:1. For example, it may be 1:2. Longer exhalation cycles help regulate the parasympathetic nervous system and are conducive to relaxation. In all cases, the stimulus will exhibit a repetitive "unit" or "cycle" of the pattern, and the frequency refers to the repetition frequency of the unit or cycle, and the period refers to the duration spanned by one instance of this unit or cycle of the pattern.

[0035] In some embodiments, the above-mentioned response actions can be used to guide the user to improve the synchronization state. Additionally or alternatively, the response actions can be used to directly adjust the stimulation to improve the synchronization state.

[0036] In some embodiments, the processing device is adapted to perform one or more adjustments to the cycle phase of the first user-perceptible stimulus to align it with the user's current breathing phase. In other words, the above-mentioned responsive action includes performing the above-mentioned one or more adjustments to the cycle phase of the first user-perceptible stimulus.

[0037] In other words, in this set of embodiments, the processing device corrects the phase misalignment between the stimulation phase and the user's breathing phase. Thus, the stimulation starts in sync with the inspiration phase or the expiration phase. The phase is automatically synchronized with the user's breathing phase.

[0038] As described above, in some embodiments, controlling the generation of the first user-perceptible stimulus includes controlling a frequency of cycling of the first user-perceptible stimulus.

[0039] In some embodiments, one or more adjustments to the cycle phase of the first user-perceptible stimulus are performed independently of the control of the cycle frequency of the stimulus. In other words, the adjustment to the cycle phase of the first user-perceptible stimulus is performed without changing the frequency of the first user-perceptible stimulus (without changing the above-mentioned control of the frequency). In other words, between the above-mentioned adjustments, the cycle frequency is independently controlled according to the (possibly independently adjustable) cycle frequency parameter.

[0040] In some embodiments, the cycle phase can be adjusted individually, for example, on a repetitive basis, so that when a difference between a user-perceivable stimulation cycle and a user's breathing cycle is detected, the phase is adjusted to match the user's phase, but the basic frequency of the user-perceivable stimulation is maintained. In other words, it is proposed to distort the user-perceivable stimulation cycle in a single case or intermittently to correct or compensate for the phase difference that occurs between it and the user's breathing rhythm, but to maintain the basic pattern of the signal. Therefore, discrete adjustments or compensations of the phase or cycle period of the stimulation can be applied at intermittent time points, but between these adjustments, the stimulation cycle is allowed to proceed at its original frequency. Adjustment can include phase transitions of the stimulation cycle, i.e., jumping to different parts of the cycle. Adjustment can include temporarily speeding up or slowing down the stimulation rhythm to "catch up" with the user's breathing rhythm and then returning to the original frequency. Adjustment can include shortening the current cycle or extending the current cycle to achieve phase alignment. Those skilled in the art will recognize that there are a variety of specific means for achieving this effect.

[0041] In some embodiments, the one or more adjustments described above are performed at repeated / repeated time points.

[0042] In some embodiments, performing one or more adjustments includes: at each of the above-mentioned repeated time points: detecting any difference between the cycle phase of the first user-perceivable stimulus and the user's breathing phase; and adjusting the cycle phase of the first user-perceivable stimulus so that it matches the user's breathing phase.

[0043] During the period between the above-mentioned repeated time points, the first user-perceptible stimulus may be generated at a fixed or independently controlled recurring frequency.

[0044] To address the problem outlined above, namely that stimuli currently used in the art are jarring or stressful to the user, the inventors have devised a new method of generating stimuli.

[0045] In some embodiments, the first user-perceivable stimulus is a tactile or haptic stimulus.

[0046] In some embodiments, the first user-perceivable stimulus comprises a cyclic motion caused by an actuation mechanism. Motion stimulation has not been considered before and is very advantageous. Motion does not evoke sensations like sound or visual stimulation, or even like vibration stimulation. It is a gentler stimulus and is naturally consistent with the action of breathing itself, appearing as a movement pattern.

[0047] For example, in some embodiments, the cyclical motion comprises cyclical expansion and contraction of at least a portion of the article adapted to be in contact with a user during use.

[0048] In some embodiments, the actuation mechanism is a pneumatic actuation mechanism, and wherein the first user-perceivable stimulus comprises cyclic inflation and deflation of a bladder integrated within the article.

[0049] As will be discussed in more detail below, in some embodiments, the article can be a pillow or cushion that a user can hold against the body, which cyclically expands and contracts to provide a cyclical pattern.

[0050] A second aspect of the invention may be a sleep aid device comprising: one or more stimulus generators operable to generate one or more user-perceptible stimuli having one or more sensory modalities; a physiological sensor; and a processing device, wherein the sleep aid device comprises an article for physical contact with a user during sleep induction, and wherein the physiological sensor is integrated into the article, and wherein a first user-perceptible stimulus comprises a cyclical movement of at least a portion of the article, such as a cyclical expansion and contraction of at least a portion of the article, and the article comprises an actuation component for achieving the above-mentioned cyclical movement.

[0051] Returning to the problem of synchronization between the stimulation phase and the breathing phase, an alternative solution is proposed below.

[0052] In some embodiments, the processing device is adapted to control the generation of a second user-perceivable stimulus indicating a synchronization state between the cycle phase of the first user-perceivable stimulus and the user's breathing phase. In other words, the above-mentioned response action may include the above-mentioned control of the second user-perceivable stimulus. By transmitting an indication of the synchronization state to the user, this helps the user to synchronize his breathing more smoothly with the first stimulation phase.

[0053] This provides feedback to the user to allow the user to adjust their breathing if the breathing is not synchronized to a certain level.

[0054] In some embodiments, the second user-perceivable stimulus comprises a stimulus that is continuously generated when the user's breathing phase is synchronized with the cycle phase of the first user-perceivable stimulus, and is not generated when the user's breathing phase is not synchronized with the cycle phase of the first user-perceivable stimulus. This gives positive reinforcement feedback to guide the user to keep their breathing phase synchronized with the phase of the first user-perceivable stimulus.

[0055] In some embodiments, the second user-perceivable stimulus comprises a vibration stimulus.

[0056] In some embodiments, when the user's breathing phase is synchronized with the cyclic phase of the first user-perceivable stimulus, the amplitude of the vibration is modulated in sync with the user's breathing phase. In other words, when the user is properly synchronized with the guiding (first) stimulus, they are given positive reinforcement in the form of a cyclic second user-perceivable stimulus that follows the rhythm of their breathing.

[0057] In some embodiments, the second user-perceptible stimulus comprises a modulation of a baseline or an offset of a cyclical pattern of the first user-perceptible stimulus.

[0058] In other words, this set of embodiments proposes to use a (further) modulation applied to the first stimulus (ie the stimulus for inducing the breathing rhythm) to provide synchronization status feedback to the user.It is proposed to modulate the baseline intensity of the first user-perceivable stimulus.

[0059] A third aspect of the invention is a sleep aid device comprising: one or more stimulus generators operable to generate one or more user-perceivable stimuli having one or more sensory modalities; a physiological sensor; and a processing device according to any embodiment described in this document or according to any claim.

[0060] In some embodiments, the sleep aid further comprises an article for physical contact with a user during sleep induction; and wherein the physiological sensor is integrated into the article.

[0061] In some embodiments, the article has a fabric surface and / or the article is cushioned at least at its surface.

[0062] In some embodiments, the article is a pillow or a cushion.

[0063] In some embodiments, the article is intended to be held by a user with one or more hands against their body, such as to be grasped or hugged by the user so that their hands are in continuous contact with the device.

[0064] In some embodiments, the physiological sensor is arranged to have a sensitive area accessible for physical contact at the surface of the article. For example, the sensor may be a PPG sensor.

[0065] In some embodiments, the above-mentioned sensitive area of ​​the physiological sensor is covered by a pocket or covering element extending over the sensitive area, the pocket or covering element being attached to the surface of the article, and wherein the sensitive area is accessible for physical contact via an opening of the pocket or covering element. For example, this can be a flexible or fabric covering element.

[0066] In some embodiments, the device further comprises a finger placement guide for guiding a user to physically place a finger over the sensitive area.

[0067] In some embodiments, the finger placement guide provides a physical or tactile guide for guiding the placement of the finger without visual observation by the user.

[0068] In some embodiments, the finger placement guide is adapted to releasably hold the finger in place.

[0069] In some embodiments, the finger placement guide includes a strap through which a user can insert their finger to hold the finger in place.

[0070] Any of the various embodiments of the above method can also be embodied in the form of a method.

[0071] Therefore, a fourth aspect of the present invention provides a sleep induction method, the method comprising: receiving an input sensor signal from a physiological sensor; and generating a first user-perceptible stimulus, which is cyclically patterned to guide the user to match the rhythm of his or her breathing with the cyclic phase of the user-perceptible stimulus.

[0072] The cycle frequency of the first user-perceptible stimulus may be controlled based on a physiological parameter determined from processing of the physiological sensor signal.

[0073] Any optional features that have been outlined above with respect to the processing device may also be embodied as features of the method.

[0074] In some embodiments, the method further comprises processing the physiological sensor signal to determine a heart rate variability (HRV) of the user, and setting the frequency of the first user-perceivable stimulation based thereon.

[0075] In some embodiments, the method comprises implementing a calibration procedure for setting a cyclic frequency of the first user-perceptible stimulus, the calibration procedure comprising a series of epochs, and wherein:

[0076] The recurrence frequency of the first user-perceptible stimulus is set to a different respective value in each respective period;

[0077] During each epoch, the physiological sensor signals are processed to determine the user's HRV;

[0078] The cycle frequency of the first user-perceptible stimulus is set during the calibration process equal to the cycle frequency consistent with the highest measured HRV.

[0079] In some embodiments, the method may further include monitoring respiration or breathing phase of the user based on processing of input physiological sensor signals associated with the user.

[0080] In some embodiments, the method further comprises configuring the cycle phase of the first user-perceivable stimulus based on the user's breathing phase. In some embodiments, the method further comprises configuring the initial or starting cycle phase of the first user-perceivable stimulus based on the user's breathing phase. Additionally or alternatively, in some embodiments, the method further comprises determining a synchronization state between the cycle phase of the first user-perceivable stimulus and the user's breathing phase. In some embodiments, the method further comprises performing a response action based on the synchronization state.

[0081] In some embodiments, the method includes performing one or more adjustments to the cycle phase of the first user-perceivable stimulus to align it with the user's current breathing phase. In other words, the above-mentioned responsive action includes performing the above-mentioned one or more adjustments.

[0082] In some embodiments, the method includes controlling the generation of a second user-perceivable stimulus indicating a synchronization state between a cycle phase of the first user-perceivable stimulus and a phase of the user's breathing. In other words, the above-mentioned response action may include the above-mentioned control of the second user-perceivable stimulus. By transmitting an indication of the synchronization state to the user, this helps the user to synchronize his breathing more smoothly with the first stimulation phase.

[0083] In a fifth aspect, the invention is a method for controlling a sleep aid. The sleep aid comprises one or more stimulus generators operable to generate user-perceivable stimuli having one or more sensory modalities. The sleep aid further comprises a physiological sensor for generating sensor data. The method comprises:

[0084] receiving sensor data from a physiological sensor;

[0085] determining a user's breathing phase based on the sensor data;

[0086] providing a first control signal to one or more stimulus generators to generate a first user-perceivable stimulus to guide a user to match the user's breathing rhythm to a cycle frequency of the first user-perceivable stimulus, wherein the first control signal is provided to generate the first user-perceivable stimulus having a cycle frequency and a cycle phase;

[0087] determining a synchronization state between a cycle phase of a first user-perceivable stimulus and a breathing phase of a user;

[0088] A second control signal is provided to the one or more stimulus generators to generate a second user-perceptible stimulus based on the synchronization state.

[0089] In one embodiment, the method is performed by a processing device.

[0090] In one embodiment, the second user-perceivable stimulus comprises a vibration stimulus.

[0091] In one embodiment, the second control signal is provided to modulate the amplitude of the vibration stimulus based on the synchronization state.

[0092] In one embodiment, the first user-perceivable stimulus comprises a vibration stimulus. The method comprises determining an inhalation cycle and an exhalation cycle from the sensor data, and providing a first control signal to increase the vibration stimulus during the inhalation cycle of the breathing phase, and to decrease the vibration stimulus during the exhalation cycle of the breathing phase.

[0093] In one embodiment, the first control signal and the second control signal are provided simultaneously to one or more stimulation generators.

[0094] In one embodiment, the method includes determining a heart rate variability (HRV) of the user based on the sensor data, and setting a cyclic frequency of the first user-perceptible stimulus based on the heart rate variability.

[0095] In one embodiment, the method comprises implementing a calibration procedure for setting a cyclic frequency of the first user-perceptible stimulus, the calibration procedure comprising a series of epochs, and wherein:

[0096] The recurrence frequency of the first user-perceptible stimulus is set to a different respective value in each respective period;

[0097] During each epoch, the sensor data is processed to determine the user's HRV;

[0098] The cycle frequency of the first user-perceptible stimulus is set during the calibration process equal to the cycle frequency consistent with the highest measured HRV.

[0099] In one embodiment, the method includes performing one or more adjustments to a cycle phase of the first user-perceptible stimulus to align with a current breathing phase of the user.

[0100] In one embodiment, the method includes providing a second control signal to continuously generate the second user perceptible stimulus when the breathing phase is synchronized with the cycle phase of the first user perceptible stimulus, and not generating the second user perceptible stimulus when the breathing phase is not synchronized with the cycle phase of the first user perceptible stimulus.

[0101] In a sixth aspect of the invention, the invention is a sleep aid comprising one or more stimulus generators operable to generate one or more user-perceivable stimuli having one or more sensory modalities; a physiological sensor for generating sensor data; and a processing device configured to perform the method according to the fifth aspect of the invention.

[0102] In one embodiment, the physiological sensor is a PPG sensor.

[0103] In one embodiment, the first user-perceivable stimulus is a tactile or haptic stimulus and comprises a cyclic motion caused by an actuation mechanism.

[0104] In one embodiment, the cyclical motion comprises cyclical expansion and contraction of at least a portion of the article adapted to be in contact with a user during use, and optionally wherein the actuation mechanism is a pneumatic actuation mechanism, and wherein the first user-perceivable stimulus comprises cyclical inflation and deflation of a bladder integrated within the article.

[0105] In one embodiment, a sleep aid comprises an article for physical contact with a user during sleep induction; and wherein the physiological sensor is integrated into the article.

[0106] In one embodiment, the article has a fabric surface and / or the article is cushioned at least at its surface; and / or the article is intended to be held by a user against his or her body with one or more hands; and / or the article is a pillow or cushion.

[0107] In one embodiment, the physiological sensor is arranged to have a sensitive area accessible for physical contact at the surface of the article, and wherein the above-mentioned sensitive area of ​​the physiological sensor is covered by a pocket or a covering element extending over the sensitive area, the pocket or the covering element is attached to the surface of the article, and wherein the sensitive area is accessible for physical contact via an opening of the pocket or the covering element. Optionally, the device also includes a finger placement guide for guiding a user to physically place a finger over the sensitive area.

[0108] In a seventh aspect of the invention, the invention is a computer program product comprising instructions which, when executed on a processing device, cause the processing device to perform the method according to the fifth aspect of the invention.

[0109] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiment(s) described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0110] For a better understanding of the invention, and to show more clearly how it may be put into practice, reference will now be made, by way of example only, to the accompanying drawings, in which:

[0111] Figure 1 schematically illustrates components of an example sleep aid device including a processing apparatus according to one or more embodiments of the present invention;

[0112] Figure 2 The steps of an example method according to one or more embodiments of the present invention are outlined;

[0113] Figure 3 Outlining the steps of another example method according to one or more embodiments of the present invention;

[0114] Figure 4 schematically illustrates an example process for adjusting a cycle phase of a first user-perceivable stimulus;

[0115] Figure 5 Outlining the steps of another example method according to one or more embodiments of the present invention;

[0116] Figure 6 Heart rate variability (HRV) relative to breathing phase is shown;

[0117] Figure 7 Outlining the steps of another example method according to one or more embodiments of the present invention;

[0118] Figure 8 schematically illustrates components of another example sleep aid device including a processing apparatus according to one or more embodiments of the present invention;

[0119] Fig. 9 Outlining the steps of another example method according to one or more embodiments of the present invention;

[0120] Fig.10 A method of patterning a second user-perceivable stimulus according to one or more embodiments is shown;

[0121] Fig.11 Outlining the steps of another example method according to one or more embodiments of the present invention;

[0122] Fig.12 Outlining the steps of another example method according to one or more embodiments of the present invention;

[0123] Fig.13 Outlining the steps of another example method according to one or more embodiments of the present invention;

[0124] Fig.14 An example sleeping aid in the form of an article for holding against the body is shown;

[0125] Figure 15-16 An example sleep aid device including an integrated physiological parameter sensor is shown according to one or more embodiments of the present invention; and

[0126] Fig.17 Shows Figure 15-16 A feature of a device for guiding a finger to be placed over an example physiological parameter sensor.

[0127] Fig.18 Yet another example method according to one or more embodiments of the invention is shown. DETAILED DESCRIPTION

[0128] The present invention will be described with reference to the accompanying drawings.

[0129] It should be understood that while indicating exemplary embodiments of the apparatus, system and method, the detailed description and specific examples are for illustrative purposes only and are not intended to limit the scope of the invention. These and other features, aspects and advantages of the apparatus, system and method of the present invention will be better understood through the following description, the appended claims and the accompanying drawings. It should be understood that these figures are merely schematic diagrams and are not drawn to scale. It should also be understood that the same reference numerals are used in the drawings to indicate the same or similar parts.

[0130] The present invention provides improved components for guiding a user to perform rhythmic breathing for sleep induction. A processing device controls the generation of a cyclically patterned user-perceivable stimulus to guide the user to pace his or her breathing. In some embodiments, components are included for controlling the cyclic frequency of a first user-perceivable stimulus based on a physiological parameter determined from processing of a physiological sensor signal.

[0131] Furthermore, as mentioned above, in currently known rhythmic breathing devices, when the user follows the correct pattern or frequency of stimulation, the phases may be misaligned or completely reversed. For example, the stimulation may be in the inspiration phase, but the user is in the exhalation phase. This is not a problem when the inspiration and exhalation duration ratio is 1:1. However, the inspiration and exhalation ratio of slow rhythmic breathing may not be 1:1, for example it may be 1:1.2, etc. When the phases are reversed, the exercise performance will change radically and may cause discomfort to the user.

[0132] In existing solutions, the start phase of the stimulation is fixed when the device is powered on and is not aligned with the user's inhalation phase. The user must adjust their inhalation or exhalation phase to match the start phase. In addition, the user must adjust their breathing to be consistent, and this may cause the user to interrupt their breathing to frequently synchronize their inhalation or exhalation with the pacemaker. In other words, the user may need to adjust their inhalation and exhalation phases according to the stimulation. As mentioned above, this can cause anxiety or stress reactions, disrupting the sleep induction state, and therefore contradicting the overall goal of sleep induction.

[0133] Thus, at least one set of embodiments of the present invention is directed to addressing the problem that the phase of stimulation may not match the user's breathing phase.

[0134] Figure 1 The components of an example processing device 32 according to one or more embodiments are summarized in block diagram form. The processing device 32 is adapted to perform the steps of the method, and the method also forms an aspect of the present invention. Before further explanation in the form of an example embodiment, the features of the processing device will now be summarized.

[0135] Figure 1 The processing device 32 is shown in the context of an exemplary apparatus in which the processing device 32 forms a component of the sleep aid device 12. However, the processing device 32 itself may be provided as an aspect of the present invention. In some embodiments, it may be provided as a component of a sleep aid device, such as Figure 1 In some embodiments, it may be provided as part of a system including the sleep aid 12 and a processing device 32 separate from the sleep aid.

[0136] The processing device 32 includes input / output 34 and one or more processors 36 .

[0137] In general, the processing device is for use with a sleep aid 12 that includes one or more stimulus generators 42 operable to generate one or more user-perceivable stimuli having one or more sensory modalities, and the sleep aid 12 includes a physiological sensor 44 for sensing a physiological parameter of a user of the device. For example, the processing device may be arranged to be operably coupled to the one or more stimulus generators 42 and the physiological sensor 44, e.g., via the input / output 34.

[0138] The processing device is adapted to perform the method, for example using one or more processors 36 .

[0139] The steps of the method according to one or more embodiments are shown in block diagram form. Figure 2 Shown in.

[0140] The processing device is adapted to receive an input sensor signal from a physiological sensor.

[0141] The processing device 32 is further adapted to control, using at least the first stimulus generator 42, the generation 54 of a first user perceptible stimulus that is cyclically patterned to induce the user to match the rhythm of his or her breathing to the cycle phase and cycle frequency of the first user perceptible stimulus.

[0142] In some embodiments, the processing device is adapted to control the frequency of cycles of the first user-perceptible stimulus in dependence on a physiological parameter determined from processing of the physiological sensor signal. This feature will be described in detail later in this document.

[0143] Optionally, in some embodiments, the processing device 32 is adapted to monitor 52 the breathing phase of the user 46 based on processing of input sensor signals from the physiological sensor 44 .

[0144] Optionally, in some embodiments, the processing device is adapted to configure an initial cycle phase of the first user-perceptible stimulation based on the user's breathing phase. For example, this ensures that the stimulation starts in alignment with the user's breathing phase.

[0145] Optionally, in some embodiments, the processing device 32 is adapted to determine 56 a synchronization state between the cycle phase of the first user-perceivable stimulus and the user's breathing phase. For example, this can be done at one or more points after the first user-perceivable stimulus begins to check the phase synchronization state. In some embodiments, the processing device 32 is further adapted to perform a response action based on the synchronization state.

[0146] In some embodiments, the processing device is adapted to: monitor the user's breathing phase over one or more cycles using input physiological sensor signals; generate and start cyclically patterned user-perceivable stimulation whose starting phase is synchronized with the user's breathing phase at the beginning; optionally, at one or more subsequent points during operation, determine the synchronization state between the first user-perceivable stimulation phase and the breathing phase; and optionally, adjust the phase of the first user-perceivable stimulation to align with the user's breathing phase.

[0147] The above physiological sensor can be a heart rate sensor or a pulse rate sensor. It can be a PPG sensor. The respiratory cycle phase can be derived from the pulse or heart rate sensor signal. In particular, the signal can be derived from the pulse rate as a function of time, and the beginning of the increase of the pulse rate signal can be used to align with the beginning of the inspiration phase, and the beginning of the decrease of the pulse rate signal can be used to align with the beginning of the decrease of the exhalation phase. In fact, the rising part of the heart rate or pulse rate variation curve (heart rate or pulse rate as a function of time) corresponds to the inspiration phase, while the falling part of the signal corresponds to the exhalation phase. Therefore, using the heart rate or pulse rate signal, the inspiration and exhalation phases can be easily detected. The respiration or breathing rate can also be detected by determining the interval frequency of the peaks of the heart rate signal.

[0148] Regarding the first user perceptible stimulus, there are many different options for the sensory modality used. In a set of embodiments described in more detail below, tactile stimulation is used for the first user perceptible stimulus. With tactile stimulation, the user can close his eyes during a rhythmic breathing activity, and his senses are minimally disturbed by the stimulation. A set of embodiments to be discussed later proposes the use of an item that can be held against the body, such as a pillow, which will cyclically expand and contract to transmit the guided stimulus, and the user follows the rhythm of the expansion and contraction. This is an elegant solution because it simulates the organic movement of the chest during breathing, and is therefore an intuitive and understandable stimulus for guiding breathing. For example, the item can inflate and deflate the internal air bag by controlling a pump. Another example of tactile stimulation is the use of a vibration motor, such as in a wristband worn by the user or in a handheld device. The vibration device will consume less power and can have a smaller size than a pneumatic system for inflation / deflation. However, there are other ways to generate the expansion and contraction of an item (such as a pillow), such as a more compact actuator.

[0149] Note that in the context of the present disclosure, references to the "phase" of a first user-perceivable stimulation cycle and breathing cycle at a given time refer to the portion of the cycle covered up to a given point in time. In other words, at a given point in time, the phase of a stimulation cycle or breathing cycle refers to the portion of the current cycle covered up to that given point in time. In general, the phase can be mathematically represented by a single variable parameter (φ) that ranges from a starting value of zero to a defined maximum value φ_max (i.e., [0, φ_max]), and where for a cycle of period (i.e., duration) T, the phase φ at time t t It can be obtained by t =(φ_max / T)*t+φ offset Given, where φ offset is the offset or starting phase of the loop pattern.

[0150] As described above, in some embodiments, the processing device 32 is also adapted to perform a response action based on the synchronization state. There are different options in the response action. One common method is to take steps to adjust the phase of the first user-perceivable stimulus to improve the synchronization state. Another common method is to transmit the synchronization state to the user to help the user improve synchronization.

[0151] Figure 3 The steps of an example method according to the first general method are summarized in block diagram form. Figure 2 In addition to the steps outlined in , the method also includes the additional step of performing 60 one or more adjustments to the current cycle phase of the first user-perceivable stimulus to align it with the user's current breathing phase (or at least improve the alignment, i.e., bring it closer to alignment). In other words, performing a responsive action including the one or more adjustments described above.

[0152] As described above, preferably, the processing device can be adapted to configure the initial cycle phase of the first user-perceivable stimulus based on the user's breathing phase. For example, this can be performed when the device is started, or when rhythmic breathing guidance is started. This ensures that the stimulus starts in alignment with the user's breathing phase. For example, the processing device 32 can be adapted to perform a startup routine, which includes: monitoring the breathing phase of multiple breathing cycles of the user based on the processing of the input sensor signal from the physiological sensor; starting to generate the first user-perceivable stimulus; and wherein the first user-perceivable stimulus starts at the starting phase of its cycle pattern, and wherein the starting phase is set to match the current cycle phase of the user's breathing cycle at the starting moment.

[0153] After initiation, one or more adjustments may be performed to the phase of the first user-perceivable stimulus. In other words, one or more further adjustments may be performed after the first user-perceivable stimulus has begun, based on monitoring of the user's respiration or breathing cycle throughout the operation. One or more adjustments may be performed at repetitive or repeated time points throughout the operation period. In some embodiments, performing any of the one or more adjustments may include, at the time point when the adjustment is performed: detecting any difference between the cyclic phase of the first user-perceivable stimulus and the user's breathing phase; and adjusting the cyclic phase of the first user-perceivable stimulus so that it matches (or better matches) the user's breathing phase.

[0154] Figure 4 An example process of adjusting a phase φ of an example first user-perceivable stimulus is schematically illustrated.

[0155] Figure 4 (a) shows a waveform 72 of an example first user-perceivable stimulus. The waveform indicates a cyclic pattern of the first user-perceivable stimulus. For example, the waveform represents the intensity of the generated stimulus as a function of time, thereby guiding the user to regulate his breathing according to the cyclically patterned stimulus. Figure 4 (a) further shows a waveform 74 of the user's breathing as a function of time. Figure 4 (a) indicates the initial time point t0, at which the stimulation is in phase with the user's breathing.

[0156] Figure 4 (b) indicates a later point in time t1 at which the stimulus 72 and the user's breathing phase 74 have become out of sync with each other and are therefore no longer in phase.

[0157] Figure 4 (c) schematically illustrates an example adjustment Δφ of the phase of the first user perceptible stimulus 72. In this example, the adjustment comprises translating the phase of the first user perceptible stimulus by a phase difference or phase shift Δφ in order to align it so as to align it with the user's current breathing phase at time t1. Waveform 72a indicates the first user perceptible stimulus waveform before the phase adjustment, while waveform 72b indicates the first user perceptible stimulus waveform after the phase adjustment.

[0158] Figure 4 (d) shows the waveform 72 of the first user perceptible stimulation at time t1 after phase adjustment.The first user perceptible stimulation then follows the same pattern and frequency as before, but the phase is aligned with the phase of the breathing cycle at time t1.

[0159] Note that preferably, the specific cyclic pattern followed by the first user-perceptible stimulus (including, for example, the frequency or period of the stimulus) is set and controlled independently of any phase adjustments that may be performed. To illustrate this more accurately, in some embodiments, controlling the generation of the first user-perceptible stimulus includes controlling the cyclic frequency or period of the first user-perceptible stimulus, and wherein one or more adjustments to the cyclic phase of the first user-perceptible stimulus are performed independently of the control of the cyclic frequency or period of the stimulus. In other words, one or more adjustments to the cyclic phase of the user-perceptible stimulus are performed without changing the basic period or frequency of the cyclically patterned first user-perceptible stimulus. For example, during the period between the above-mentioned repetitive time points, the first user-perceptible stimulus can be generated with a fixed or independently controlled cyclic frequency.

[0160] Note that in the context of the present disclosure, the terms cycle frequency and cycle period as applied with respect to the first user-perceivable stimulus refer to the repetition frequency of each cycle of the cyclic pattern embodied by the first user-perceivable stimulus. This can be a smooth sinusoidal pattern or a pattern of different shapes, for example, tilted to induce a longer exhalation than an inhalation. For example, each cycle of the cyclically patterned first user-perceivable stimulus may include an inhalation phase portion and an exhalation phase portion, and the durations of the inhalation phase portion and the exhalation phase portion may be different from each other. In other words, the ratio between the duration of the inhalation phase portion and the exhalation phase portion may not be 1:1. For example, it may be 1:2. Longer exhalation cycles help regulate the parasympathetic nervous system and are conducive to relaxation. For example, in one breathing cycle, the inhalation duty cycle to the exhalation duty cycle may be 1:1, 1:1.5, or 1:2, etc. In all cases, the stimulus exhibits a repetitive "unit" or "cycle" of the pattern, and the frequency refers to the repetition frequency of the unit or cycle, and the period refers to the duration spanned by one instance of this unit or cycle of the pattern. A phase is the part of a particular cycle currently in progress that has been passed at a given point in time.

[0161] By way of illustration, an example implementation of the method according to a particular set of embodiments that the inventors believe to be particularly advantageous can be summarized as including the following steps / features:

[0162] - In response to detecting the start of the user's inhalation using the physiological parameter sensor, starting the inhalation phase of the first user-perceivable stimulation (i.e., the phase for guiding the user to inhale). For example, this can be performed when the device is turned on. For example, this corresponds to the startup routine mentioned above.

[0163] - For example, in response to detecting a phase asynchrony, lengthening or shortening the current user-perceivable stimulation cycle to match the stimulation to the phase of the user's inhalation / exhalation.

[0164] Optionally, the method further comprises monitoring the stability of the user's breathing cycle, and performing the above one or more adjustments of the user-perceivable stimulus only in response to detecting that the user's breathing is relatively stable, thereby filtering out undesirable noise and making the system as a whole more stable.

[0165] The overall goal may be to automatically adjust the first user perceptible stimulus to match the inhalation or exhalation phase, but preferably maintain the fundamental lead frequency of the first user perceptible stimulus.

[0166] Features for configuring the frequency or period of the first user-perceivable stimulus will now be described. These features may be embodied in an apparatus or method according to one or more embodiments. The described features may be combined with any one of the one or more embodiments described above, or may be provided as a separate aspect of the present invention.

[0167] According to this aspect of the invention, there is provided a processing device for a sleep aid device, the sleep aid device comprising one or more stimulus generators operable to generate one or more user-perceivable stimuli having one or more sensory modalities, and the sleep aid device further comprising a physiological sensor. The processing device may be configured to generate a user-perceivable stimulus having one or more sensory modalities, wherein the user-perceived stimulus is generated by the user's sensor. Figure 1 processing equipment.

[0168] The processing device is adapted to:

[0169] receiving an input sensor signal from a physiological sensor;

[0170] controlling generation of a first user perceptible stimulus that is cyclically patterned to induce a user to match the rhythm of his or her breathing to a cycle phase and a cycle frequency of the first user perceptible stimulus; and

[0171] Wherein the processing device is adapted to control a cycle frequency of the first user-perceptible stimulus in dependence on a physiological parameter determined from processing of the physiological sensor signal.

[0172] In some embodiments, now discussed in greater detail below, the method further includes processing the physiological sensor signal to determine a heart rate variability (HRV) of the user, and setting the frequency of the first user-perceivable stimulus based thereon.

[0173] Embodiments of this aspect of the invention may be combined with features described in any other embodiments described in this document.

[0174] Figure 5The steps of an example method according to one or more embodiments are summarized in block diagram form. These steps will be generally described before further explanation in the form of an example embodiment. The method includes: controlling the generation 54 of a first user-perceivable stimulus that is cyclically patterned to induce a user to match the rhythm of his or her breathing to the cyclic phase and cyclic frequency of the first user-perceivable stimulus; processing physiological sensor signals to determine or monitor 82 the user's heart rate variability (HRV), and setting 84 the frequency of the first user-perceivable stimulus based thereon.

[0175] Note that the order of the steps may be different. For example, step 54 of generating a user-perceivable stimulus may be performed only after the cycle frequency is set, so that the first user-perceivable stimulus starts at the HRV-adapted frequency. However, the cycle frequency may also be adjusted after the first user-perceivable stimulus has started. For example, it may be started using a default cycle frequency and adjusted after startup.

[0176] The steps of this method can be combined with the steps of any other method described in this disclosure, for example, Figure 7 As shown (described later). In addition, Figure 5 The method itself represents an invention, because it itself provides an advantageous technical effect, namely improving the effect of rhythmic breathing guidance by adjusting the frequency of the guided stimulation according to the HRV of the user. Therefore, the method can be provided as a separate aspect of the present invention. In addition, a processing device configured to perform the method is an aspect of the present invention. In addition, a computer program product including code means is another aspect of the present invention, and the code means is configured to cause the processor to perform the method when running on the processor.

[0177] As will now be explained in further detail, HRV is an important biological indicator for determining optimal parameters for rhythmic breathing.

[0178] Heart rate is not constant, but varies with each heartbeat. In particular, heart rate increases with the onset of inhalation and decreases when the individual begins to exhale. Figure 6 This is schematically shown in , where line 76 indicates an example heart rate of an individual, and this is shown superimposed on the user's inhalation and exhalation phases 74. This illustrates the concept that the heart rate increases with inhalation and decreases with exhalation.

[0179] Furthermore, the degree of heart rate irregularity varies depending on the state of arousal. When an individual is in a state of stress, their heartbeat will be more regular, and when an individual is in a more relaxed state, their heartbeat will be more irregular. This can be represented by the heart rate variability (HRV) parameter. A low HRV corresponds to a more stressed state. In fact, a persistently low HRV can even be a cause of death. A higher HRV corresponds to a more relaxed state.

[0180] Additionally, a person's breathing rhythm affects their relaxation level via biofeedback from the cardiovascular system.

[0181] In the context of sleep induction, the goal is to achieve a state of maximum relaxation (minimum arousal or minimum stress state). This will correspond to a state of maximum HRV. It is well known that breathing rhythm can change a person's stress and relaxation level. Therefore, the purpose is to set a frequency or period of a cyclically patterned first user-perceivable stimulus so that it guides the user to adopt a (matching) breathing rhythm that causes the highest possible HRV for the user. In other words, the purpose is to guide the user to adopt a breathing rhythm associated with the highest HRV achievable by the user. In the technical field, the term "resonant HRV frequency" is sometimes used to represent the breathing cycle frequency associated with the highest HRV.

[0182] As a rough guide, this resonant frequency is typically in the range of 4.5-6.5 breaths per minute and varies between individuals and even at different times in the same individual depending on the physiological state.

[0183] In some embodiments, the processing device may be configured to set the cyclic frequency of the first user-perceptible stimulus equal to the frequency associated with the user's highest HRV.

[0184] A process may be included for determining the user's breathing rate associated with the highest HRV.

[0185] The process may involve varying the cycle frequency of the first user-perceptible stimulus, measuring the HRV at each cycle frequency, and then setting the cycle frequency of the first user-perceptible stimulus equal to the cycle frequency of the different set frequencies that is consistent with the highest measured HRV amplitude.

[0186] For example, a calibration process for setting the cyclic frequency of a first user-perceptible stimulus can be implemented, the calibration process comprising a series of periods, and wherein: the cyclic frequency of the first user-perceptible stimulus is set to a different corresponding value in each corresponding period; during each period, the physiological sensor signal is processed to determine the user's HRV; the cyclic frequency of the first user-perceptible stimulus is set during the calibration process to be equal to the cyclic frequency consistent with the highest measured HRV.

[0187] For example, different respective values ​​of the cyclic frequency in different periods may be set to frequencies that vary within a window spanning a predefined typical range of HRV resonant frequency values ​​for an individual. For example, this may be a window centered at, for example, 5.5 breaths per minute.

[0188] The physiological sensor can be a heart rate sensor or a pulse rate sensor. It can be a PPG sensor. HRV can be derived from the pulse or heart rate signal.

[0189] In addition, the respiratory cycle phase can also be derived from the pulse or heart rate sensor. In particular, the start of the pulse rate increase is aligned with the start of the inhalation phase, and the start of the pulse rate decrease is aligned with the start of the exhalation phase decrease. In fact, the rising part of the heart rate or pulse rate variation curve (heart rate or pulse rate as a function of time) corresponds to the inhalation phase, while the falling part of the signal corresponds to the exhalation phase. Therefore, using the heart rate or pulse rate signal, the inhalation and exhalation phases can be easily detected. The breathing rate can also be detected by determining the interval frequency of the peak values ​​of the heart rate signal.

[0190] Compared to ECG-based HRV detection, HRV measurements may be less accurate. However, in the context of the present invention, the absolute value of HRV is not necessary; instead, it is only necessary to identify the maximum HRV measurement relative to other HRV measurements so that the relevant stimulation frequency associated with the maximum HRV can be identified. As described above, the frequency of the first user-perceivable stimulation associated with the highest HRV amplitude corresponds to the HRV resonant frequency.

[0191] Thus, the pulse sensor can be used to determine the user's HRV resonant frequency, and this can be used to set the frequency of the first user-perceivable stimulation to guide the user to a breathing rhythm known to be associated with the user's maximum HRV. In other words, the HRV resonant frequency is used as a target guided breathing frequency for sleep induction. In this way, a personalized rhythmic breathing stimulation device can be implemented.

[0192] The steps associated with setting the cyclic frequency of the first user-perceivable stimulus may be combined with the steps of any other method described in this disclosure or provided by itself. As an example, Figure 7The steps of an example method according to one or more embodiments are summarized in block diagram form. The details of each step have been described in this document, and the reader can therefore refer to the relevant paragraphs above for more details. The method includes: monitoring 52 the breathing phase of the user based on the processing of the input sensor signal from the physiological sensor; controlling the generation 54 of a first user-perceivable stimulus, which is cyclically patterned to guide the user to match the rhythm of its breathing with the cyclic phase and cyclic frequency of the first user-perceivable stimulus; processing the physiological sensor signal to determine 82 or monitor the heart rate variability (HRV) of the user, and setting 84 the frequency of the first user-perceivable stimulus based on it; and determining 56 the synchronization state between the cyclic phase of the first user-perceivable stimulus and the user's breathing phase. The method may also include performing a response action, such as performing 60 one or more adjustments to the cyclic phase of the first user-perceivable stimulus to align it with the user's current breathing phase.

[0193] Instead, steps 82 and 84 may be performed before generation of the first user-perceptible stimulus begins, such that the stimulus begins with a cyclic frequency determined based on the HRV.

[0194] Now an example implementation of the method according to a set of specific embodiments will be described by way of further illustration. It should be understood that not all features of this set of specific embodiments are necessary for the inventive concept, and these features are described to help understand and provide examples to illustrate the inventive concept.

[0195] In a first step, the user places a finger on a pulse sensor integrated into the sleep aid. For example, the sleep aid may include an article adapted to be in contact with the user during use, such as a cushion or a pillow, and the pulse sensor is integrated into the article and is designed to have a sensitive area accessible at the surface of the article for physical contact. The user breathes at his own pace in this stage.

[0196] The user's inhalation and exhalation phases are detected by the pulse signal, and the cyclically patterned first user-perceivable stimulus begins at such a time so as to be in phase with the user's inhalation phase or exhalation phase. For example, in some embodiments (to be described in more detail below), the first user-perceivable stimulus is a tactile or tactile stimulus and includes a cyclic motion caused by an actuating mechanism. For example, in some embodiments, the cyclic motion includes cyclic expansion and contraction of at least a portion of an article adapted to be in contact with the user during use. For example, the actuating mechanism can be a pneumatic actuating mechanism, and wherein the first user-perceivable stimulus includes cyclic inflation and deflation of a bladder integrated in the above-mentioned article. In this case, the article can be controlled so that inflation begins when the user begins to inhale, and deflation begins when the user begins to exhale.

[0197] Thus, the start phase of the first user-perceivable stimulation is automatically synchronized with the user's breathing phase. During the stimulation, the synchronization can be adjusted to correct any asynchrony that has formed, for example by short pauses in the stimulation. This concept has been described in some detail above.

[0198] The stimulation frequency can then be set to the HRV resonant frequency (see the discussion above for more details). As a brief reminder, the HRV resonant frequency can be acquired in one of the following ways. As an example, a calibration or practice phase can be implemented to detect the HRV resonant frequency. For example, the user triggers a calibration phase, and practice use is performed during this phase. In this calibration phase, the frequency of the first user-perceivable stimulation will be set to a series of different values, such as approximately 4.5, 5, 5.5, 6, 6.5 cycles per minute, for example 2 minutes each. Each corresponding HRV amplitude can be detected by the pulse signal as described above. The HRV resonant frequency is the frequency value of the first user-perceivable stimulation that is consistent with the maximum HRV amplitude measured during the calibration phase. The HRV resonant frequency is stored and used as the cyclic frequency of the first user-perceivable stimulation during the main operation phase of the device for sleep induction.

[0199] As an alternative to the above scheme, the resonant HRV amplitude can be derived during the main operation phase for sleep induction. In particular, during the main operation, the frequency of the first user-perceivable stimulation can be varied across a series of different values, for example starting from 5.5 cycles per minute, decreasing by 0.5 cycles per minute to 5 cycles per minute after 2 minutes, and increasing to 6 cycles per minute after another 2 minutes. The stimulation frequency that results in the highest measured HRV frequency in the process is recorded as the HRV resonant frequency and stored for use. The cycle frequency of the first user-perceivable frequency is then set to the determined HRV resonant frequency until sleep occurs.

[0200] The processing device may include a memory for storing the determined value of the HRV resonance amplitude

[0201] In some embodiments, a first contact of the user's body with the pulse sensor may be detected, and wherein in response to the detection the user's breathing phase is automatically monitored and initiation of the first user-perceivable stimulus is triggered to start in unison with the user's breathing cycle.

[0202] During the main sleep induction operation, the user controls his breathing to follow the rhythmic stimulation. After the onset of sleep, the user's breathing rate will typically begin to increase, for example from about 5.5 times per minute during the sleep induction period to about 15 times per minute after the onset of sleep. At the same time, the heart rate will decrease compared to the awake state. These two conditions (i.e., increased breathing rate and decreased heart rate) can be used together to detect the onset of sleep. In response to detecting the onset of sleep, the processing device can be adapted to stop the first user-perceivable stimulation to avoid disturbing the user's sleep.

[0203] In some embodiments, the frequency of the first user-perceivable stimulus can be gradually adjusted in a stage-synchronous manner during sleep induction. For example, the respiratory rate of an adult may typically have a value of about 12-18 cycles per minute, while the HRV resonant frequency may typically be at a value of about 5.5 cycles per minute. In order not to suddenly jump to a much lower frequency (which may be uncomfortable), a transition phase may be implemented in which the cyclic frequency of the user-perceivable stimulus is adjusted downward in a stepwise manner from a starting value (e.g., a predefined value or a value matching the user's current respiratory rate) to a value matching the determined target cyclic frequency calculated from the HRV. For example, when the first user-perceivable stimulus begins, it may be controlled to start at a frequency of 70% of the user's respiratory rate (e.g., 12*0.7≈9bpm) for 2 minutes, and then if the frequency is still above the HRV resonant frequency, switch down again by 70%, and so on, until the determined target cyclic frequency is reached. The step size (e.g., percentage drop) may vary, such as 60%, 75%, or 80%, etc. In some examples, the step size may vary between steps, such as becoming smaller as the target cyclic frequency approaches. The step size can be adjusted manually or automatically.

[0204] As previously described, in some embodiments, in addition to or instead of adjusting the phase of the first user-perceivable stimulus, the processing device 32 may be adapted to control the generation of a second user-perceivable stimulus indicating a synchronization state between the cycle phase of the first user-perceivable stimulus and the user's breathing phase. In some embodiments, the sleep aid may further include a second stimulus generator for generating the second user-perceivable stimulus.

[0205] Figure 8 The components of an exemplary sleep aid device 12 according to one or more embodiments of the present invention are schematically outlined. The sleep aid device is similar in all respects to the exemplary sleep aid device 12 except for the additional inclusion of a second stimulation generator 46. Figure 1 This is just one example. In some embodiments (and as will be further described later), the second user-perceivable stimulus may be generated by the same stimulus generator as the first user-perceivable stimulus.

[0206] In one advantageous implementation, the first user-perceivable stimulus may comprise cyclic expansion and contraction of at least a portion of the article adapted to be in contact with a user during use, and wherein the second user-perceivable stimulus comprises a vibration. The two stimuli may be generated simultaneously.

[0207] Fig. 9 The steps of an example method according to one or more embodiments of the present invention are summarized. For example, Figure 8 The processing device 32 may be adapted to perform the method. The method may be provided as a separate aspect of the present invention, and the processing device 32 may be adapted to perform the method. Figure 8 The processing device 32 may be provided as a separate aspect of the present invention; and / or a Figure 8 The sleep aid device 12 may be provided as a separate aspect of the present invention. In summary, the method comprises the following steps: monitoring 52 the breathing phase of the user based on processing of input sensor signals from the physiological sensor 44; controlling 54 the generation of a first user-perceivable stimulus that is cyclically patterned to induce the user to match the rhythm of his breathing with the cyclic phase and cyclic frequency of the first user-perceivable stimulus; determining 56 the synchronization state between the cyclic phase of the first user-perceivable stimulus and the breathing phase of the user; and controlling the generation 92 of a second user-perceivable stimulus that indicates the synchronization state between the cyclic phase of the first user-perceivable stimulus and the breathing phase of the user.

[0208] Now will describe the example implementation of the method according to a set of specific embodiments by illustrating the above generalized concepts.It should be understood that not all features of this set of specific embodiments are necessary for the inventive concept, and these features are described to help understand and provide examples to illustrate the inventive concept.

[0209] An individual's normal breathing is cyclic, similar to a tidal cycle, with repetitions of inhalation and exhalation phases.

[0210] Fig.10 (Top) shows variations of this breathing cycle. During the inhalation phase 102, the chest wall contracts, and during the exhalation phase 104, the chest wall relaxes. After each exhalation phase 104, there is a natural pause in breathing 106 before the next inhalation 102 begins. During breathing, the individual feels the pressure cyclically changing in a manner similar to the tidal cycle.

[0211] In some embodiments, to simulate such tidal changes in pressure, the first user-perceivable stimulus 54 may be gradually controlled in a cyclical manner. This is achieved in practice by the first user-perceivable stimulus being in the form of a vibration stimulus, and wherein the amplitude of the vibration is cyclically or periodically patterned to provide a cyclical pattern of stimulus to guide the user's breathing rhythm.

[0212] Fig.10 (Bottom) shows a waveform 108, which schematically illustrates an example of a cyclic pattern of a first user-perceivable stimulus according to one or more embodiments. It is shown aligned with the phases of the user's breathing cycle (top). The waveform 108 indicates changes in vibration amplitude as a function of time.

[0213] Fig.10 The amplitude variation shown follows a linear rise during the inhalation phase and a linear fall during the exhalation phase. However, a non-linear variation of the vibration amplitude can also be performed. With this approach, the sensation of the vibration increases during the inhalation cycle and decreases during the exhalation cycle. With this progressive variation of the amplitude, the user can easily follow the rhythm of the guided stimulation with his eyes closed, without disturbing a calm state of mind.

[0214] Note that the above-described method for generating a first user-perceivable stimulus may actually be implemented as a part of any embodiment described in the present disclosure.

[0215] Continuing with the description of this set of example embodiments, the method further comprises monitoring the user's breathing phase 52 while generating the first user-perceivable stimulus. This can be achieved using, for example, a heart rate or pulse rate signal in the manner already discussed above. For example, a PPG sensor is a simple way to obtain such a signal.

[0216] By detecting the user's respiration or breathing rate, the synchronization state of the user's respiration with the first user-perceivable stimulus can be determined 56, and fed back 92 to the user through the second user-perceivable stimulus. As previously mentioned, when the user follows the correct breathing frequency or rhythm, the phase of his breathing cycle may be out of sync with or even completely opposite to the phase that guides the first user-perceivable stimulus. For example, the stimulus is in the inhalation phase, but the user is in the exhalation phase.

[0217] There are different options for feeding back the synchronization state to the user, as described below: It can be generated in a different sensory modality than the first stimulus; It can be generated in the same sensory modality as the first stimulus, for example as a modulation of the first stimulus. In some examples, the feedback of the synchronization state can be tactile feedback, for example with a fixed intensity or a progressive vibration intensity.

[0218] According to one example implementation, the cyclically varying vibration stimulus discussed previously may be used as a second user-perceivable stimulus (e.g., in addition to a separate first user-perceivable stimulus that directs the user's breathing rhythm), and wherein the second stimulus: is continuously generated when the user's breathing phase is synchronized with the cyclic phase of the first user-perceivable stimulus; and is not generated when the user's breathing phase is not synchronized with the cyclic phase of the first user-perceivable stimulus. For example, the second user-perceivable stimulus includes a vibration stimulus, and when the user's breathing phase is synchronized with the cyclic phase of the first user-perceivable stimulus, the amplitude of the vibration is modulated in synchronization with the user's breathing phase.

[0219] For example, the implementation can be understood from the following example case:

[0220] Case 1: The first user-perceivable stimulus is in the inhalation phase, and the user's breathing is in the inhalation phase. In this case, the second user-perceivable stimulus is generated as a continuous vibration whose amplitude (ie, intensity) gradually increases in sync with the user's breathing phase.

[0221] Case 2: The first user-perceivable stimulus is in the inhalation phase, and the user's breathing is in the exhalation phase. In this case, the second user-perceivable stimulus is stopped, i.e. no vibration is fed back to the user, or a different vibration pattern is used for the second user-perceivable stimulus, for example, a series of short vibrations may be fed back to convey to the user that there is a phase mismatch.

[0222] Case 3: The first user-perceivable stimulus is in the exhalation phase, and the user's breathing is in the exhalation phase. In this case, the second user-perceivable stimulus is generated as a continuous vibration whose amplitude (ie, intensity) gradually decreases in sync with the user's breathing phase.

[0223] Case 4: The first user-perceivable stimulus is in the exhalation phase, and the user's breathing is in the inhalation phase. In this case, the second user-perceivable stimulus is stopped, i.e. no vibration is fed back to the user, or a different vibration pattern is used for the second user-perceivable stimulus, for example, a series of short vibrations may be fed back to convey to the user that there is a phase mismatch.

[0224] As a more general principle, according to the exemplary method, the feedback and feedback intensity provided by the second user-perceptible stimulus allows the user to feel his or her breathing through positive feedback vibrations during those times when his or her breathing is synchronized with the first user-perceptible stimulus (which guides his or her rhythmic breathing).

[0225] In the above example implementation, the first user-perceivable stimulus may be another vibration stimulus, or may be a stimulus of a different modality. For cases where vibration is used as the first user-perceivable stimulus, an additional vibrator may be used to provide synchronization state feedback. Alternatively, both the first stimulus and the second stimulus may be generated with a single vibrator, and wherein the second user-perceivable stimulus comprises a modulation of a baseline or offset of a cyclical pattern of the first user-perceivable stimulus. In other words, when the stimulation phase is synchronized with the user's breathing phase, the baseline vibration intensity of the first stimulus (used to guide the breathing rhythm) may be increased, for example by 20%, and this baseline change may provide a second stimulus to convey a synchronization state.

[0226] However, it should also be noted that the above implementation of the second stimulus is not limited to use with the first user-perceivable stimulus of vibration. For example, the first user-perceivable stimulus can be an optical or visual stimulus, or an acoustic stimulus, or a tactile stimulus, such as the expanding / contracting item briefly mentioned above (and further described below).

[0227] For example, where a first user-perceivable stimulus is generated as the expansion / contraction of a pillow, a continuous vibration response may be generated by the vibrator (as a second user-perceivable stimulus) when the user's inhalation is synchronized with the expansion of the pillow. When the user's inhalation is not synchronized with the expansion phase of the pillow, no vibration is fed back to the user, or a different vibration pattern is generated to convey the mismatch.

[0228] Thus, following the principles of the specific example implementations described above, a set of components of a particularly advantageous embodiment may include the following:

[0229] A sleep aid device (e.g., a wristband, handheld device, or hugging device) having a stimulation component for generating rhythmic stimulation to guide a user to pace their breathing, such as by simulating inhalation and exhalation tendencies through progressive vibrations.

[0230] Sensors (eg, PPG sensors) provided on the sleep aid device are used to track the user's inhalation and exhalation.

[0231] A tactile feedback component (eg, a vibrator) is used to provide continuous feedback as the user's breathing is synchronized with the rhythm of the stimulation.

[0232] Any of the above features or method steps may be combined or integrated with any other method described in this document. As an example, Fig.11The steps of an example method according to one or more embodiments are summarized in block diagram form. The details of each step have been described in this document, and therefore the reader can refer to the relevant paragraphs above for more details. The method includes: monitoring 52 the breathing phase of the user based on processing of input sensor signals from physiological sensors; controlling the generation 54 of a first user-perceivable stimulus, which is cyclically patterned to guide the user to match the rhythm of its breathing with the cyclic phase and cyclic frequency of the first user-perceivable stimulus; processing the physiological sensor signal to determine or monitor 82 the heart rate variability (HRV) of the user, and setting 84 the frequency of the first user-perceivable stimulus based thereon; determining 56 the synchronization state between the cyclic phase of the first user-perceivable stimulus and the user's breathing phase; and controlling the generation 92 of a second user-perceivable stimulus indicating the synchronization state between the cyclic phase of the first user-perceivable stimulus and the user's breathing phase.

[0233] Alternatively, steps 82 and 84 may instead be performed before generation 54 of the first user-perceptible stimulus begins, such that the stimulus begins with a cyclic frequency determined based on the HRV.

[0234] As another example, Fig.12 The steps of another example method according to one or more embodiments are summarized in block diagram form. The details of each step have been described in this document, and therefore the reader can refer to the relevant paragraphs above for more details. The method includes: monitoring 52 the breathing phase of the user based on processing of input sensor signals from physiological sensors; controlling the generation 54 of a first user-perceivable stimulus, which is cyclically patterned to guide the user to match the rhythm of his breathing with the cyclic phase and cyclic frequency of the first user-perceivable stimulus; determining 56 the synchronization state between the cyclic phase of the first user-perceivable stimulus and the user's breathing phase. Based on the determined synchronization state, the method includes performing two response actions: performing one or more adjustments 56 to the cyclic phase of the first user-perceivable stimulus to align it with the user's current breathing phase; and controlling the generation 92 of a second user-perceivable stimulus indicating the synchronization state between the cyclic phase of the first user-perceivable stimulus and the user's breathing phase.

[0235] As another example, Fig.13 The steps of another example method according to one or more embodiments are summarized in block diagram form. Fig.11 and Fig.12The method is a combination of methods. The details of each step have been described in this document, and therefore the reader can refer to the relevant paragraphs above for more details. The method includes: monitoring 52 the breathing phase of the user based on the processing of the input sensor signal from the physiological sensor; controlling the generation 54 of a first user-perceivable stimulus, which is cyclically patterned to guide the user to match the rhythm of his breathing with the cyclic phase and cyclic frequency of the first user-perceivable stimulus; processing the physiological sensor signal to determine or monitor 82 the heart rate variability (HRV) of the user, and setting 84 the frequency of the first user-perceivable stimulus based thereon; determining 56 the synchronization state between the cyclic phase of the first user-perceivable stimulus and the user's breathing phase. Based on the determined synchronization state, the method includes performing two response actions: performing one or more adjustments 56 on the cyclic phase of the first user-perceivable stimulus to align it with the user's current breathing phase; and controlling the generation 92 of a second user-perceivable stimulus indicating the synchronization state between the cyclic phase of the first user-perceivable stimulus and the user's breathing phase.

[0236] Note that in any of the above methods, the step of determining the cyclic frequency of the first user-perceptible stimulus may be performed before the first user-perceptible stimulus is first generated or after the first user-perceptible stimulus is first generated. Therefore, the specific order of the steps shown in each figure is not essential, and the order of the steps may vary. For example, the method may include: initially monitoring physiological sensor signals before starting the first user-perceptible stimulus; determining the HRV of the user; monitoring the breathing phase of the user; determining the cyclic frequency for the stimulation based on the HRV using the method already described above; and starting the first user-perceptible stimulus at the determined cyclic frequency and preferably also at a starting phase that matches the breathing phase of the user at the starting point.

[0237] Further optional details related to the components for generating the first user-perceivable stimulus and compatible with any embodiment of the present invention, as well as options related to the structure of the sleep aid device will now be briefly described. In addition, the advantageous arrangement discussed below represents an invention in itself, as it provides an advantageous technical effect that can be achieved independently of the other features already discussed.

[0238] According to one or more embodiments, it is proposed to generate the previously discussed first user-perceivable stimulus (for inducing rhythmic breathing of the user) using an article that can be held by a user and expresses a cyclic motion caused by an actuation mechanism, the cyclic motion providing the first stimulus. In some embodiments, it is proposed that at least a portion of the article undergoes cyclic expansion and contraction as the first user-perceivable stimulus.

[0239] Fig.14An example item 112 in the form of a cushion or pillow is shown. The cushion or pillow can be used to be held against the body by the user. This can be called a hug pillow. For example, its contour or shape can conform to the shape of the body so as to fit comfortably against the body. The expansion and contraction of the device will be felt by the user and guide the user to follow the rhythm of the movement of his breathing.

[0240] For example, the actuation mechanism may be a pneumatic actuation mechanism, and the first user-perceivable stimulus comprises cyclic inflation and deflation of a bladder integrated within the article 112. For example, a pillow may be provided that is designed to inflate to prompt the user to inhale and deflate to prompt the user to exhale.

[0241] According to one or more embodiments, a system may be provided, the system comprising a system according to any of the embodiments discussed above (e.g., according to Figure 1 or Figure 8 ) of the embodiment, and also includes an item for providing a first stimulation generator as described above.

[0242] According to one or more embodiments, there may be provided a sleep aid device comprising: one or more stimulus generators operable to generate one or more user-perceivable stimuli having one or more sensory modalities; a physiological sensor; and a processing device according to any embodiment described in this document.

[0243] Now, a preferred implementation of a sleep aid according to a set of specific embodiments will be described by way of illustration. It should be understood that not all features of this set of specific embodiments are necessary for the inventive concept, and these features are described to help understand and provide examples to illustrate the inventive concept.

[0244] In this set of embodiments, it is proposed to provide a sleep aid device, which includes an article for physical contact with a user during sleep induction, and in which the physiological sensor is integrated in the article. For example, the article can be a pillow or a cushion, such as the bolster already mentioned above. However, more generally, the article can be any article that can be held by the user. The article can preferably have a fabric surface and / or be cushioned at least at its surface. The article is preferably suitable for being held by the user against his body with one or more hands, i.e., grasped or hugged by the user, so that his hands are in continuous contact with the device.

[0245] With regard to physiological sensors, it is proposed to preferably use a PPG sensor arranged to have a sensitive area accessible for physical contact at the surface of the article. This allows continuous monitoring of the user's heart rate while the user is holding the article, while the expansion and contraction (or other stimulation) provides guidance for the user to pace his breathing.

[0246] Heart rate can be used to track the user's breathing phase. In addition, as described above, in some embodiments, heart rate can be used to determine the HRV biofeedback resonant frequency (referring to the frequency that stimulates the user to exhibit the highest HRV rhythmic breathing). The resonant frequency can optionally be used as a target guided breathing frequency for sleep induction.

[0247] As described above, in some embodiments, by using the PPG signal to track the breathing phase, the phase of the first user-perceivable stimulus providing the breathing guide can be automatically adjusted to align with the user's inhalation / exhalation phase. This helps the user breathe in sync with the rhythm of the breathing guide.

[0248] Optionally, the start and stop of the first user-perceptible stimulation may be automatically triggered depending on the sleep / wake state of the user.

[0249] Fig.15 , Fig.16 and Fig.17 Advantageous features according to certain one or more embodiments are schematically illustrated.

[0250] like Fig.15 As shown, it is proposed to provide an integrated physiological parameter sensor 122 for an article 112, which is arranged with a sensitive area accessible at the surface of the article for physical contact. For example, it is proposed to mount a pulse sensor on the surface of the article.

[0251] In addition, if Fig.16 As shown, in some embodiments, it is proposed to provide a pocket or cover element 132 extending over the sensitive area of ​​the sensor 122, which allows the user to place it in his or her hand 124. For example, the pocket or cover element 132 is attached to the surface of the article, and wherein the sensitive area of ​​the sensor 122 is accessible via an opening of the pocket or cover element for physical contact.

[0252] like Fig.16 and Fig.17 As shown, in some embodiments, the device also includes a finger placement guide 142 for guiding the user to physically place a finger over the sensitive area of ​​the sensor 122. This helps to fix the position of the user's finger relative to the sensor 122 to obtain stable pulse signal detection. In the example shown, the finger placement guide 142 includes a belt or annular band extending over the pulse sensor, and the user can insert his finger through the belt or annular band to keep the finger in the appropriate position. More generally, a finger placement guide can be provided that can provide a physical or tactile guide to guide the placement of the finger without visual observation by the user. The finger placement guide is preferably adapted to releasably hold the finger in the appropriate position.

[0253] In some embodiments, integrated within the interior space of the article 112 may be an inflatable bladder (e.g., an air inflatable bladder or bag), and a pump for varying the inflation level of the bladder, and a controller for controlling the pump. This provides a pneumatic actuation mechanism for controlling the expansion and contraction of the article by inflation and deflation of the bladder. Thus, the action may provide the first user-perceivable stimulus discussed previously.

[0254] A pillow is an example of a user-friendly unit that can be used as the item 112 discussed previously. However, the above implementation is not limited to using a pillow. For example, other devices such as handheld devices can be used. In addition, expansion / contraction as the first user-perceivable stimulus is not essential. Instead, other stimulation means, such as light and / or sound, etc., can also be used.

[0255] By way of brief summary, features of one particular implementation that the inventors believe to be particularly advantageous may include one or more of the following features:

[0256] - A sleep inducing device (eg a pillow or a cushion) having a stimulation member, such as an air bag or a mechanical inflation and deflation member, for generating a rhythmic first user-perceivable stimulus.

[0257] - A PPG sensor mounted on the surface of a pillow or cushion to sense blood pulse through the fingertips.

[0258] - A finger strap or pouch to cover the PPG sensor on the pillow to guide stable positioning of the finger on the sensor.

[0259] - A microcontroller or processing device for calculating and preferably monitoring the user's HRV over time and generating a real-time breathing curve of the user from the blood pulse signal for tracking the user's breathing phase.

[0260] - The same or a different microcontroller or processing device for controlling the generation of rhythmic stimulation, preferably for example by setting the rhythm of the stimulation to the frequency of the highest HRV (referred to above as the HRV resonance frequency).

[0261] Fig.18Another embodiment of the present invention is shown. In this embodiment, a method for controlling a sleep aid device 12 is provided. The sleep aid device 12 includes one or more stimulus generators 42 operable to generate user-perceivable stimuli having one or more sensory modalities. The sleep aid device also includes a physiological sensor 44 for generating sensor data. The method includes steps 1301-1304. Step 1301 includes receiving sensor data from the physiological sensor 44. Step 1302 includes determining a breathing phase of a user based on the sensor data. Step 1303 includes providing a first control signal to one or more stimulus generators 44 to generate a first user-perceivable stimulus to guide the user to match the user's breathing rhythm with a cyclic frequency of the first user-perceivable stimulus. The first control signal is provided to generate a first user-perceivable stimulus having a cyclic frequency and a cyclic phase. Step 1304 includes determining a synchronization state between the cyclic phase of the first user-perceivable stimulus and the breathing phase of the user. Step 1305 includes providing a second control signal to one or more stimulus generators 42 to generate a second user-perceivable stimulus based on the synchronization state. For example, the method is performed by a processing device.

[0262] Optionally, the second user-perceivable stimulus comprises a vibration stimulus. Optionally, as shown in step 1305, a second control signal is provided to modulate the amplitude of the vibration stimulus based on the synchronization state.

[0263] Optionally, the first user-perceivable stimulus comprises a vibration stimulus.The method comprises determining an inhalation cycle and an exhalation cycle from the sensor data, and providing a first control signal to increase the vibration stimulus during the inhalation cycle of the breathing phase and to decrease the vibration stimulus during the exhalation cycle of the breathing phase.

[0264] Optionally, the first control signal and the second control signal are provided simultaneously to one or more stimulation generators.

[0265] Optionally, the method comprises determining a heart rate variability (HRV) of the user based on the sensor data, and setting a cyclic frequency of the first user-perceptible stimulus based on the heart rate variability.

[0266] Optionally, the method comprises implementing a calibration procedure for setting a cyclic frequency of the first user-perceptible stimulus, the calibration procedure comprising a series of epochs, and wherein:

[0267] The recurrence frequency of the first user-perceptible stimulus is set to a different respective value in each respective period;

[0268] During each epoch, the sensor data is processed to determine the user's HRV;

[0269] The cycle frequency of the first user-perceptible stimulus is set during the calibration process equal to the cycle frequency consistent with the highest measured HRV.

[0270] Optionally, the method includes performing one or more adjustments to the cycle phase of the first user-perceptible stimulus to align with the user's current breathing phase.

[0271] Optionally, the method comprises providing a second control signal to continuously generate the second user perceptible stimulus when the breathing phase is synchronized with the cycle phase of the first user perceptible stimulus, and not generating the second user perceptible stimulus when the breathing phase is not synchronized with the cycle phase of the first user perceptible stimulus.

[0272] In one embodiment, a sleep aid comprises one or more stimulus generators 42 operable to generate one or more user-perceivable stimuli having one or more sensory modalities, a physiological sensor 44 for generating sensor data, and a processing device 32 configured to perform a sleep aid according to the present invention. Fig.18 The method of the embodiment in FIG.

[0273] Optionally, the physiological sensor is a PPG sensor.

[0274] Optionally, the first user-perceivable stimulus is a tactile or haptic stimulus and comprises a cyclic motion caused by an actuation mechanism.

[0275] Optionally, the cyclical motion comprises cyclical expansion and contraction of at least a portion of the article adapted to be in contact with a user during use, and optionally, wherein the actuation mechanism is a pneumatic actuation mechanism, and wherein the first user-perceivable stimulus comprises cyclical inflation and deflation of a bladder integrated within the above-mentioned article.

[0276] Optionally, the sleep aid comprises an article 112 for physical contact with a user during sleep induction; and wherein the physiological sensor 44 is integrated in the article 122 .

[0277] Optionally, article 122 has a fabric surface and / or the article is cushioned at least at its surface; and / or the article is intended to be held by a user against his or her body with one or more hands; and / or article 122 is a pillow or cushion.

[0278] Optionally, the physiological sensor 44 is arranged to have a sensitive area accessible for physical contact at the surface of the article 122, and wherein the above-mentioned sensitive area of ​​the physiological sensor is covered by a pocket or covering element 132 extending over the sensitive area, the pocket or covering element 132 is attached to the surface of the article 122, and wherein the sensitive area is accessible for physical contact via an opening of the pocket or covering element 132. Optionally, the device also includes a finger placement guide 142 for guiding a user to physically place a finger over the sensitive area.

[0279] In one embodiment, the present invention is a computer program product comprising instructions that, when executed on processing device 32, cause processing device 32 to perform a process according to Fig.18 The method of an embodiment.

[0280] Any features described above with respect to any other embodiment may also be combined with this set of embodiments. For example, a treatment device may be provided as part of a sleep aid, the treatment device being consistent with any of the above embodiments. Article 122 may be combined with any of the treatment devices already described above.

[0281] As mentioned above, the present invention can be embodied in software. Therefore, another aspect of the present invention is a computer program product comprising code means, which is configured to cause the processor to perform a method according to the examples or embodiments of the present invention described in this document, or according to any claim of this patent application when it is run on a processor.

[0282] The embodiments of the present invention described above employ a processing device. The processing device may generally include a single processor or multiple processors. It may be located in a single containing device, structure or unit, or may be distributed between multiple different devices, structures and units. Therefore, references to a processing device adapted or configured to perform a particular step or task may correspond to the step or task being performed by any one or more of a plurality of processing components, either individually or in combination. Those skilled in the art will understand how such a distributed processing arrangement can be implemented. The processing device may include a communication module or input / output for receiving data and outputting data to another component.

[0283] One or more processors of a processing device may be implemented in software and / or hardware in a variety of ways to perform the various functions required. The processor typically employs one or more microprocessors that may be programmed using software (e.g., microcode) to perform the required functions. The processor may be implemented as a combination of dedicated hardware that performs some functions and one or more programmed microprocessors and associated circuitry that performs other functions.

[0284] Examples of circuitry that may be used in various embodiments of the present disclosure include, but are not limited to, conventional microprocessors, application specific integrated circuits (ASICs), and field programmable gate arrays (FPGAs).

[0285] In various implementations, the processor may be associated with one or more storage media, such as volatile and non-volatile computer memory, such as RAM, PROM, EPROM, and EEPROM. The storage media may be encoded with one or more programs that perform the desired functions when executed on one or more processors and / or controllers. The various storage media may be fixed within the processor or controller, or may be transportable so that one or more programs stored thereon may be loaded into the processor.

[0286] Variations to the disclosed embodiments may be understood and implemented by those skilled in the art in practicing the claimed invention by studying the drawings, the present disclosure, and the appended claims. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality.

[0287] A single processor or other unit may fulfill the functions of several items recited in the claims.

[0288] The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

[0289] The computer program may be stored / distributed on a suitable medium, such as optical storage media or solid-state media provided with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunications systems.

[0290] If the term "adapted to" is used in the claims or the description, it should be noted that the term "adapted to" is intended to be equivalent to the term "configured to".

[0291] Any reference signs in the claims should not be construed as limiting the scope.

Claims

1. A computer program product comprising instructions which, when executed on a processing device (32) of a sleep aid device (12), The sleep aid (12) includes one or more stimulus generators (42) operable to generate user-perceivable stimuli having one or more sensory modalities, and also includes a physiological sensor (44) for generating sensor data, causing the processing device (32) to execute a method for controlling the sleep aid apparatus, The method comprises: receiving the sensor data from the physiological sensor (44); determining a breathing phase of the user based on the sensor data; providing a first control signal to the one or more stimulus generators (42) to generate a first user-perceivable stimulus to guide a user (46) to match a breathing rhythm of the user (46) to a cycle frequency of the first user-perceivable stimulus, wherein the first control signal is provided to generate the first user-perceivable stimulus having the cycle frequency and cycle phase; determining a state of synchronization between the cycle phase of the first user-perceptible stimulus and the breathing phase of the user; A second control signal is provided to the one or more stimulus generators (42) to generate a second user-perceivable stimulus based on the synchronization state, wherein the second user-perceivable stimulus comprises a vibration stimulus, wherein the second control signal is provided to modulate an amplitude of the vibration stimulus based on the synchronization state.

2. The computer program product of claim 1 , wherein the first user-perceivable stimulus comprises a vibration stimulus, The method comprises: determining an inspiratory cycle and an expiratory cycle based on the sensor data, and The first control signal is provided to increase the vibration stimulation during an inhalation cycle of the breathing phase and to decrease the vibration stimulation during an exhalation cycle of the breathing phase.

3. The computer program product according to any one of claims 1 to 2, wherein the first control signal and the second control signal are provided simultaneously to the one or more stimulation generators (42).

4. A computer program product according to any one of claims 1 to 3, comprising determining a heart rate variability (HRV) of the user based on the sensor data, and setting the cyclic frequency of the first user-perceivable stimulus based on the heart rate variability.

5. The computer program product of claim 4, comprising implementing a calibration procedure for setting the cyclic frequency of the first user-perceivable stimulus, the calibration procedure comprising a series of epochs, and wherein: the recurring frequency of the first user-perceptible stimulus being set to a different respective value in each respective period; During each epoch, the sensor data is processed to determine the HRV of the user; The cycle frequency of the first user-perceptible stimulus is set during the calibration process equal to the cycle frequency consistent with the highest measured HRV.

6. A computer program product according to any preceding claim, comprising performing one or more adjustments to the cycle phase of the first user-perceptible stimulus to align with a current breathing phase of the user.

7. A computer program product according to any of the preceding claims, comprising providing the second control signal to continuously generate a second user-perceptible stimulus when the breathing phase is synchronized with the cycle phase of the first user-perceptible stimulus, and not generating the second user-perceptible stimulus when the breathing phase is not synchronized with the cycle phase of the first user-perceptible stimulus.

8. A sleeping aid device, comprising: one or more stimulus generators (42) operable to generate one or more user-perceivable stimuli having one or more sensory modalities; A physiological sensor (44) for generating sensor data; as well as A processing device configured to run the computer program product according to any one of claims 1 to 7 to perform the method for controlling the sleeping aid device.

9. The sleeping aid according to claim 8, wherein the physiological sensor (44) is a PPG sensor.

10. A sleeping aid according to claim 8 or 9, wherein the first user-perceivable stimulus is a tactile or haptic stimulus and comprises a cyclic motion caused by an actuation mechanism.

11. A sleeping aid as claimed in claim 10, wherein the cyclical movement comprises cyclical expansion and contraction of at least a portion of the article adapted to be in contact with a user during use.

12. A sleeping aid according to any one of claims 8 to 11, comprising an article for physical contact with a user during sleep induction; and Wherein the physiological sensor is integrated into the article.

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