Sleep assist apparatus and control thereof

Abstract

An improved means for guiding a user to breathe at constant speed for inducing sleep. The processing device controls the generation of cyclically modeled user-perceptible stimuli to guide the users to adjust their breathing rhythm. In some embodiments, means are included for aligning the phase of a cyclically modeled first user perceptible stimulus with the phase of the breathing cycle of the user. In some embodiments, means are included for aligning the initial (i.e., start) phase of a cyclically modeled first user perceptible stimulus with the phase of the breathing cycle of the user at the start. In some embodiments, means are included for detecting asynchronization between the phase of the pilot stimulus and the phase of the breathing cycle of the user, and performing a response based on the detected asynchronization. The response may communicate a synchronization status to the user via a second user perceptible stimulus or output. The response may be to take measures to correct any asynchronization.

Description

Technical Field

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

[0002] One third of the general adult population reports symptoms of insomnia. This is a major public health problem and can lead to decreased concentration, memory and performance, as well as physical illness. Current drug treatments can be expensive, unhealthy and cause dependence. Recent studies cited below have shown that slow-paced breathing, practiced by individuals while trying to fall asleep, helps improve sleep onset and sleep quality. This has led to the development of products designed to motivate individuals to follow a specific (slow) breathing rhythm. This concept is often referred to as paced breathing. There are various solutions to help individuals pace their breathing, such as paced breathing apps, paced breathing videos and other means.

[0003] This new area of ​​development opens up new possibilities for further improvements and optimizations as well as for 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. Summary of the invention

[0006] This disclosure summarizes a number of developments contemplated by the inventors in the field of paced breathing that are intended to address one or more shortcomings of the prior art newly recognized by the inventors.

[0007] In current solutions, a sensory stimulus is usually generated that is rhythmically patterned at a certain frequency, and the user is instructed to adjust the rhythm of their breathing to keep up with the rhythm of the stimulus. A disadvantage found by the inventor is that the phase of the guided stimulus may not match the breathing phase of the user. When the device is powered on, the phase is usually fixed and misaligned with the user's inhalation phase. Therefore, the user needs to suddenly adjust their inhalation and exhalation phases to synchronize with the phase of the periodic stimulus, such as starting a new breath by shortening the breath, or holding the breath for a longer time than is comfortable in other cases. This makes the user feel uncomfortable and emotionally uneasy, and does induce an involuntary physiological reaction of anxiety, which is contrary to the intended goal of relaxing for sleep. In addition, in some cases, the user may follow the sensory stimulus with an opposite phase. This does not cause a problem for a stimulation cycle with an inhalation phase length of 1:1 to an exhalation phase length, but when the inhalation phase length is not 1:1 to the exhalation phase ratio, such as 1:2, the performance of fixed-speed breathing is reduced.

[0008] Another shortcoming of the prior art discovered by the inventors is that the known solutions use standardized frequencies or frequency patterns for guided stimulation. However, the breathing rhythm that is most associated with sleep onset actually varies from person to person and even for a single individual, it changes over time. It is associated with certain physiological parameters of the user. Therefore, fixed-frequency, fixed-pace breathing guidance is not optimal.

[0009] Another shortcoming of the prior art is that the specific sensory modalities currently used to convey breathing guidance are somewhat inappropriate for the overall goal of inducing relaxation and sleep. For example, they often rely on periodic acoustic stimulation. However, these can in fact cause discomfort and tension, and if maintained throughout sleep, can cause sleep disturbances. Therefore, better ways of conveying target breathing patterns would be valuable.

[0010] Summarized below is a summary of concepts conceived by the inventors that are intended to address one or more of the above-identified deficiencies in the prior art.

[0011] The invention is defined by the claims.

[0012] 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 separately for use with the sleep aid device, for example for controlling the sleep aid device. Furthermore, in a second aspect of the invention is a sleep aid device comprising a processing device. Furthermore, in a third aspect of the invention, there is provided a system comprising a combined but separate sleep aid device and a processing device, for example wherein the processing device is embodied in a mobile computing device such as a smart phone. These options also apply to all other aspects of the invention.

[0013] The processing device is adapted to monitor the breathing phase of the user based on processing of input sensor signals from the physiological sensor.

[0014] The processing device is further adapted to control the generation of a first user-perceivable stimulus (generated by one or more stimulus generators) that is cyclically patterned for guiding the user to match their breathing rhythm 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 relevant stimulus.

[0015] In some embodiments, the processing device is further adapted to configure the cyclic phase of the first user-perceivable stimulus based on the user's breathing phase. The processing device may, for example, be adapted to configure the initial cyclic phase or the starting cyclic phase of the first user-perceivable stimulus based on the user's breathing phase. For example, the processing device may be adapted to set the initial cyclic phase or the starting cyclic phase of the first user-perceivable stimulus to match the cyclic phase of the user's breathing cycle. For example, the processing device may 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 stimulus may be initiated so that, at the beginning, the cyclic phase of the first user-perceivable stimulus matches the user's breathing phase.

[0016] Additionally or alternatively, in some embodiments, the processing device is further adapted to determine a synchronization state between the cyclic phase of the first user perceptible stimulus and the user's breathing phase. The synchronization state means, for example, an indication of the degree of phase alignment between the cyclic phase of the first user perceptible stimulus and the user's breathing phase.

[0017] 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 cyclic phase of the first user-perceptible stimulus and the user's breathing phase.

[0018] By determining the degree of synchronization between the phase of the paced breathing guided stimulation and the current phase of the user's breathing, measures can be taken to help reduce any misalignment therebetween. This therefore helps alleviate the problem mentioned above, where the user feels anxious and stressed due to the mismatch between their current breathing phase and the stimulation phase.

[0019] It should be noted that there is a distinction between stimulation frequency and stimulation phase. A user's breathing rate may in fact perfectly match the lead stimulation frequency, but their breathing may not match the phase of the stimulation. This can trigger a stress response that is not conducive to the relaxation state required for sleep. It is therefore valuable to provide a solution that can help improve the phase difference, even if completely independent of any control or adjustment of the underlying frequency or period of the first user-perceivable stimulation (although a solution that addresses frequency is proposed further below, and may be combined with a phase-related solution).

[0020] It should also be noted that in the context of the present disclosure, the terms breathing cycle and respiration cycle are synonymous. Therefore, references to respiration phase or frequency and references to breathing phase or frequency can be considered as references to the same thing.

[0021] It should also be noted that in the context of the present disclosure, the terms cycle frequency and cycle period applied to the first user-perceivable stimulus mean the repetition frequency of each cycle of the cyclical pattern embodied by the first user-perceivable stimulus. This may be a smooth sinusoidal pattern, or it may be a pattern of a different shape, such as one that is skewed to guide 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 pattern of repeated "units" or "cycles", and the frequency means the repetition frequency of the unit or cycle, and the period means the duration of one instance of the pattern of the unit or cycle.

[0022] In some embodiments, the above-mentioned response action can be used to guide the user to improve the synchronization state. In addition or alternatively, the response action can be used to directly adjust the stimulation to improve the synchronization state.

[0023] In some embodiments, the processing device is adapted to perform one or more adjustments to the cyclic 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 one or more adjustments to the cyclic phase of the first user-perceptible stimulus.

[0024] 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 synchronously with the inspiration phase or the expiration phase. The phase is automatically synchronized with the user's breathing phase.

[0025] As mentioned 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.

[0026] In some embodiments, one or more adjustments of the cyclic phase of the first user-perceptible stimulus are performed independently of the control of the cyclic frequency of the stimulus. In other words, the adjustments of the cyclic phase of the first user-perceptible stimulus are performed without changing the frequency of the first user-perceptible stimulus (without changing the control of the frequency). In other words, between the adjustments, the cyclic frequency is independently controlled according to the (possibly independently adjustable) cyclic frequency parameter.

[0027] In some embodiments, the phase of the cycle can be adjusted separately, 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 phase of the user, but maintain the fundamental frequency of the user-perceivable stimulation. In other words, it is proposed to distort the user-perceivable stimulation cycle once or intermittently to correct or compensate for the phase difference that occurs between it and the user's breathing rhythm, but to maintain the fundamental patterning of the signal. Therefore, the phase or cycle period of the stimulation can be discretely adjusted or compensated at intermittent time points, but between these adjustments, the stimulation cycle is allowed to continue at its original frequency. The adjustment may include a phase shift of the stimulation cycle, i.e., jumping to different parts of the cycle. The adjustment may 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. The adjustment may 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 to achieve this effect.

[0028] In some embodiments, the one or more adjustments described above are performed at repeated time points / repeated time points.

[0029] In some embodiments, performing one or more adjustments includes, at each of the repeated time points: detecting any difference between a cyclic phase of the first user-perceptible stimulus and a breathing phase of the user; and adjusting the cyclic phase of the first user-perceptible stimulus so that it matches the breathing phase of the user.

[0030] During the period between the repeated time points, the first user-perceptible stimulus may be generated at a fixed or independently controlled recurring frequency.

[0031] 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.

[0032] 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 based thereon.

[0033] 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:

[0034] In each respective period, setting the recurrence frequency of the first user-perceptible stimulus to a different respective value;

[0035] During each epoch, processing the physiological sensor signals to determine the user's HRV; and

[0036] The cycling frequency of the first user-perceptible stimulus is set equal to the cycling frequency consistent with the highest measured HRV during the calibration procedure.

[0037] In the art, this frequency that stimulates the highest measured HRV amplitude is sometimes referred to as the HRV resonant frequency.

[0038] 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.

[0039] 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 a stimulation device, and then set the cyclic frequency of the first user-perceivable stimulation to match this rhythm. This can be achieved by directly measuring a physiological parameter 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 in which the stimulation frequency is varied.

[0040] In some embodiments, the physiological sensor may be a PPG sensor.

[0041] In order to address the problem outlined above, namely that stimuli currently used in the art are unpleasant or stressful to the user, the present inventors have conceived a new method of generating stimuli.

[0042] In some embodiments, the first user-perceivable stimulus is a tactile or haptic stimulus.

[0043] In some embodiments, the first user-perceivable stimulus comprises a cyclic motion caused by an actuation mechanism. Movement stimulation has not been previously considered, and movement stimulation is very advantageous. Movement does not evoke the senses like sound stimulation or visual stimulation, or even like vibration stimulation. It is a gentler stimulus and is naturally consistent with the action of breathing itself, which embodies a movement pattern.

[0044] 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.

[0045] In some embodiments, the actuation mechanism is a pneumatic actuation mechanism, and wherein the first user-perceivable stimulus comprises cyclic inflation and deflation of an air bladder integrated within the article.

[0046] As will be discussed in more detail below, in some embodiments, the article may be a pillow or cushion that a user may fit against their body and that cyclically expands and contracts to provide a cyclical pattern.

[0047] In a fourth aspect of the invention, there may be a sleep aid 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 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 cyclical movement of at least a portion of the article, such as cyclical expansion and contraction of at least a portion of the article, and the article comprises an actuation means for achieving the cyclical movement.

[0048] Returning to the problem of synchronization between the phase of stimulation and the phase of breathing, another solution is proposed below.

[0049] In some embodiments, the processing device is adapted to control the generation of a second user-perceivable stimulus indicating a state of synchronization between a cyclic phase of the first user-perceivable stimulus and a phase of the user's breathing. In other words, the above-mentioned responsive action may include said control of the second user-perceivable stimulus. By conveying an indication of the state of synchronization to the user, this helps the user to synchronize their breathing more smoothly with the phase of the first stimulus.

[0050] This provides feedback to the user, allowing the user to adjust their breathing if they are out of sync with a certain level.

[0051] In some embodiments, the second user-perceivable stimulus includes a stimulus that is continuously generated when the user's breathing phase is synchronized with the cyclic phase of the first user-perceivable stimulus, and that is not generated when the user's breathing phase is not synchronized with the cyclic phase of the first user-perceivable stimulus. This provides positive reinforcement feedback to guide the user to keep their breathing phase synchronized with the phase of the first user-perceivable stimulus.

[0052] In some embodiments, the second user-perceivable stimulus comprises a vibration stimulus.

[0053] 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 synchronization with the user's breathing phase. In other words, when the user is correctly synchronized with the guiding (first) stimulus, they receive positive reinforcement in the form of a cyclic second user-perceivable stimulus that follows the rhythm of their breathing.

[0054] In some embodiments, the second user-perceptible stimulus comprises an adjustment to a baseline or offset of a cyclical pattern of the first user-perceptible stimulus.

[0055] In other words, the proposal in this set of embodiments is to give synchronization status feedback to the user using a (further) adjustment applied to the first stimulus (ie the stimulus for guiding the breathing rhythm).It is proposed to adjust the baseline intensity of the first user-perceivable stimulus.

[0056] In a fifth aspect, the invention is a sleeping 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 arrangement according to any embodiment or according to any claim described in this document.

[0057] 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.

[0058] In some embodiments, the article has a fabric surface and / or the article is padded at least at its surface.

[0059] In some embodiments, the article is a pillow or a cushion.

[0060] In some embodiments, the article is intended to be held by a user against their body with one or more hands, such as for grasping or hugging by the user, thereby keeping their hands in constant contact with the device.

[0061] In some embodiments, the physiological sensor is arranged to have a sensitive area that can be physically contacted at the surface of the article. For example, the sensor can be a PPG sensor.

[0062] In some embodiments, the sensitive area of ​​the physiological sensor is covered by a pocket or covering element extending above the sensitive area, the pocket or covering element being attached to the surface of the article and wherein the sensitive area is physically accessible via an opening of the pocket or covering element. This may be, for example, a textile covering element or a fabric covering element.

[0063] In some embodiments, the device further comprises a finger placement guide for guiding a user to physically place their finger over the sensitive area.

[0064] 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.

[0065] In some embodiments, the finger placement guide is adapted to releasably hold the finger in place.

[0066] In some embodiments, the finger placement guide includes a strap through which a user can insert their finger for holding the finger in place.

[0067] Any of the various embodiments of the method outlined above may also be embodied in the form of a method.

[0068] Therefore, in a sixth aspect, the present invention provides a sleep induction method, the sleep induction method comprising: monitoring the user's respiration (respiration or breathing) phase based on the processing of an input physiological sensor signal associated with the user; and generating a first user-perceivable stimulus, the first user-perceivable stimulus being cyclically patterned to guide the user to match their breathing rhythm with the cyclic phase of the user-perceivable stimulus. In some embodiments, the method further comprises configuring the cyclic phase of the first user-perceivable stimulus based on the user's breathing phase. In some embodiments, the method further comprises configuring the initial cyclic phase or the starting cyclic 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 cyclic 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.

[0069] Any of the optional features that have been outlined above in relation to the processing device may also be embodied as a feature of the method.

[0070] In some embodiments, the method includes performing one or more adjustments of the cyclic phase of the first user-perceivable stimulus so as to align it with the user's current breathing phase. In other words, the above-mentioned responsive action includes performing the one or more adjustments.

[0071] In some embodiments, the method further comprises controlling a cycle frequency of the first user-perceptible stimulus based on a physiological parameter determined from the processing of the physiological sensor signal.

[0072] In some embodiments, 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.

[0073] In some embodiments, the method comprises implementing a calibration procedure for setting a cycle frequency of the first user-perceptible stimulus, the calibration procedure comprising a series of epochs, and wherein:

[0074] In each respective period, setting the recurrence frequency of the first user-perceptible stimulus to a different respective value;

[0075] During each epoch, processing the physiological sensor signal to determine the user's HRV;

[0076] The cycling frequency of the first user-perceptible stimulus is set equal to the cycling frequency consistent with the highest measured HRV during the calibration procedure.

[0077] In some embodiments, the method includes controlling the generation of a second user-perceivable stimulus indicating a synchronization state between a cyclic phase of the first user-perceivable stimulus and a user's breathing phase. In other words, the above-mentioned responsive action may include said control of the second user-perceivable stimulus. By conveying an indication of the synchronization state to the user, this helps the user to synchronize their breathing more smoothly with the first stimulus phase.

[0078] In a seventh aspect, the invention is a method for controlling a sleep aid device, the sleep aid device comprising one or more stimulation generators operable to generate user-perceivable stimulations having one or more sensory modalities to guide a user to match a rhythm of the user's breathing with a cyclic frequency of the user-perceivable stimulations, and the sleep aid device further comprising at least one physiological sensor operable to generate sensor data. The method comprises:

[0079] receiving sensor data from at least one physiological sensor;

[0080] Determining a user's breathing phase based on the sensor data;

[0081] Based on the sensor data, determine the user's heart rate variability (HRV);

[0082] providing a control signal to one or more stimulus generators to generate a plurality of user-perceptible stimuli, each of the plurality of user-perceptible stimuli having a different cycle frequency;

[0083] determining heart rate variability for each of the different cycling frequencies;

[0084] Based on the respiratory phase and the determined heart rate variability, further control signals are provided to one or more stimulation generators to generate a first user-perceivable stimulus.

[0085] In one embodiment, the method includes determining a cyclic frequency corresponding to a highest heart rate variability among different cyclic frequencies, and after determining the cyclic frequency corresponding to the highest heart rate variability, providing a further control signal based on the cyclic frequency corresponding to the highest heart rate variability.

[0086] In one embodiment, the method includes determining a synchronization state between a cyclic phase of a first user-perceptible stimulus and a user's breathing phase, and performing a response action based on the synchronization state, and wherein the response action includes performing one or more adjustments to the cyclic phase of the first user-perceptible stimulus to align with the user's current breathing phase.

[0087] In one embodiment, one or more of the adjustments are performed at recurring points in time.

[0088] In one embodiment, the method includes determining a synchronization state between a cyclic phase of a first user-perceptible stimulus and a breathing phase of a user, and performing a response action based on the synchronization state, and wherein the response action includes providing a second control signal to at least one of the stimulus generators to generate a second user-perceptible stimulus indicating the synchronization state between the cyclic phase of the first user-perceptible stimulus and the breathing phase of the user.

[0089] In one embodiment, the second user-perceivable stimulus comprises a stimulus:

[0090] When the user's breathing phase is synchronized with the cyclic phase of the first user-perceptible stimulus, the stimulus is continuously generated; and when the user's breathing phase is not synchronized with the cyclic phase of the first user-perceptible stimulus, the stimulus is not generated.

[0091] In one embodiment, the second user-perceptible stimulus comprises a vibration stimulus. The method comprises modulating the amplitude of the vibration in synchronism with the user's breathing phase when the user's breathing phase is synchronized with the cyclic phase of the first user-perceptible stimulus.

[0092] In an eighth aspect, the invention is a sleep aid comprising one or more stimulus generators operable to generate user-perceivable stimuli having one or more sensory modalities; at least one physiological sensor; and a processing device adapted to perform the method according to the seventh aspect.

[0093] In one embodiment, a sleep aid comprises an article for physical contact with a user during sleep induction; and the physiological sensor is integrated into the article.

[0094] In one embodiment, the article is cushioned at least at a surface of the article.

[0095] In one embodiment, the article is a pillow or a cushion.

[0096] In one embodiment, at least one physiological sensor is arranged to have a sensitive area that can be physically contacted at the surface of the article, and wherein the sensitive area is covered by a pocket or covering element extending over the sensitive area, wherein the pocket or covering element is attached to the surface of the article, and wherein the sensitive area can be physically contacted through an opening of the pocket or covering element.

[0097] In one embodiment, the physiological sensor is a PPG sensor.

[0098] In one embodiment, the first user-perceivable stimulus is a tactile or haptic stimulus and comprises a cyclic motion caused by an actuation mechanism.

[0099] In a ninth aspect, the present 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 seventh aspect.

[0100] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0101] For a better understanding of the invention, and in order to more clearly show how the invention may be put into practice, reference will now be made, by way of example only, to the accompanying drawings, in which:

[0102] 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;

[0103] Figure 2 The steps of an example method according to one or more embodiments of the present invention are outlined;

[0104] Figure 3 Outlining the steps of another example method according to one or more embodiments of the present invention;

[0105] Figure 4 schematically illustrates an example procedure for adjusting a cyclic phase of a first user-perceptible stimulus;

[0106] Figure 5 Outlining the steps of further example methods according to one or more embodiments of the present invention;

[0107] Figure 6 Heart rate variability (HRV) relative to respiratory phase is shown;

[0108] Figure 7 Outlining the steps of further example methods according to one or more embodiments of the present invention;

[0109] Figure 8 schematically illustrates components of a further example sleep aid device including a processing apparatus according to one or more embodiments of the present invention;

[0110] Fig. 9 Outlining the steps of further example methods according to one or more embodiments of the present invention;

[0111] Fig.10 A method of patterning a second user-perceivable stimulus according to one or more embodiments is shown;

[0112] Fig.11 Outlining the steps of further example methods according to one or more embodiments of the present invention;

[0113] Fig.12 Outlining the steps of further example methods according to one or more embodiments of the present invention;

[0114] Fig.13 Outlining the steps of further example methods according to one or more embodiments of the present invention;

[0115] Fig.14 An example sleeping aid in the form of an article for contraposition to the body is shown;

[0116] Figure 15-16 An example sleep aid device including an integrated physiological parameter sensor according to one or more embodiments of the present invention is shown; and

[0117] Fig.17 Shows Figure 15-16 Features of the device for guiding a finger to be placed on an example physiological parameter sensor;

[0118] Fig.18

[0046] Outlined are steps for further example methods according to one or more embodiments of the invention. DETAILED DESCRIPTION

[0119] The present invention will be described with reference to the accompanying drawings.

[0120] It should be understood that the detailed description and specific examples, while indicating exemplary embodiments of the apparatus, system, and method, are intended 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 invention will be better understood through the following description, the appended claims, and the accompanying drawings. It should be understood that the drawings are merely schematic and are not drawn to scale. It should also be understood that the same reference numerals are used throughout the drawings to indicate the same or similar components.

[0121] The present invention provides an improved means for guiding a user to adjust the rhythm of breathing for inducing sleep. A processing device controls the generation of cyclically patterned user-perceivable stimuli to guide users to adjust their breathing rhythms. In some embodiments, means are included for aligning the phase of a cyclically patterned first user-perceivable stimulus with the phase of a user's breathing cycle. In some embodiments, means are included for aligning the initial (i.e., starting) phase of a cyclically patterned first user-perceivable stimulus with the phase of the user's breathing cycle at the beginning. In some embodiments, means are included for detecting asynchrony between the phase of the guiding stimulus and the phase of the user's breathing cycle, and a response is performed based on the detected asynchrony. The response can be to communicate a synchronization state to the user via a second user-perceivable stimulus or output. The response can be to take measures to correct any asynchrony.

[0122] As already discussed above, in currently known paced breathing devices, when the user is following the correct patterning or frequency of the stimulation, a phase misalignment or complete reversal may occur. For example, the stimulation may be in the inspiratory phase, but the user is in the expiratory phase. This is not a problem when the inspiratory and expiratory duration ratio is 1:1. However, the inspiratory and expiratory ratio of slow paced breathing may not be 1:1, for example it may be 1:1.2, etc. When the phases are opposite, the exercise performance is drastically changed and may cause discomfort to the user.

[0123] In existing solutions, the starting 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 phase or exhalation phase to match the starting phase. In addition, the user must make adjustments to their breathing to stay in phase, and this may cause the user to interrupt their breathing to frequently synchronize their inhalation or exhalation with the pacer. In other words, the user may need to adjust their inhalation phase and exhalation phase according to the stimulation. As previously mentioned, this may cause anxiety or tension reactions that disrupt the sleep induction state and is therefore contrary to the overall goal of sleep induction.

[0124] Therefore, at least one set of embodiments of the present invention is directed to addressing the problem that the phase of the stimulation may not match the user's breathing phase.

[0125] 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 suitable for performing the steps of the method, and the method also forms an aspect of the present invention. The features of the processing device will now be described in general terms and then further explained in the form of an example embodiment.

[0126] Figure 1 The processing device 32 is shown in the context of an exemplary arrangement in which it forms a component of the sleep aid 12. However, the processing device 32 may be provided separately as an aspect of the present invention. In some embodiments, it may be provided as a component of the sleep aid, 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.

[0127] The processing device 32 includes input / output 34 and one or more processors 36 .

[0128] The processing device is generally 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 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 an input / output 34.

[0129] The processing device 36 is adapted to perform a method, for example using one or more processing devices 36 . Figure 2 The steps of the method according to one or more embodiments are also shown in the form of a block diagram.

[0130] 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 .

[0131] The processing device 32 is further adapted to control the generation 54 of a first user perceptible stimulus using at least the first stimulus generator 42, the first user perceptible stimulus being cyclically patterned for guiding the user to match their breathing rhythm to a cyclic phase and cyclic frequency of the first user perceptible stimulus.

[0132] In some embodiments, the processing device is adapted to configure an initial cycle phase of the first user-perceptible stimulus based on the user's breathing phase. For example, this ensures that the stimulus starts aligned with the user's breathing phase.

[0133] In some embodiments, the processing device 32 is adapted to determine 56 a synchronization state between a cyclic phase of the first user-perceivable stimulus and a user's breathing phase. For example, this may be done at one or more points after the first user-perceivable stimulus has begun 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.

[0134] In some embodiments, the processing device is adapted to: monitor the user's breathing phase over one or more cycles using an input physiological sensor signal; generate and start a cyclically patterned user-perceivable stimulus, wherein a start phase of the user-perceivable stimulus starts synchronously with the user's breathing phase at the start; optionally determine a state of synchronization between a first user-perceivable stimulus phase and a breathing phase at one or more subsequent points during operation; and optionally adjust a phase of the first user-perceivable stimulus for alignment with the user's breathing phase.

[0135] The physiological sensor mentioned above 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, a signal as a pulse rate that varies according to time can be derived, and the beginning of the increase of the pulse rate signal can be aligned with the beginning of the inhalation phase, and the beginning of the decrease of the pulse rate signal can be aligned with the beginning of the decrease of the expiratory 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 inhalation phase, and the falling part of the signal corresponds to the expiratory phase. Therefore, with the help of the heart rate signal or the pulse rate signal, the inhalation phase and the expiratory phase can be easily detected. The breathing (breathing or respiration) rate can also be detected by determining the interval frequency of the peak value of the heart rate signal.

[0136] There are many different options for the sensory modality used with respect to the first user-perceivable stimulus. In a set of embodiments described in more detail below, tactile stimulation is used for the first user-perceivable stimulus. With the help of tactile stimulation, the user can close his eyes during the paced breathing activity, and their senses are minimally disturbed by the stimulation. A set of embodiments to be discussed later proposes the use of an article that can fit close to the body, such as a pillow, which expands and contracts cyclically to convey the guiding stimulus, and the user follows the rhythm of the expansion and contraction. This is an elegant solution because it mimics the organic movement of the chest during breathing, and is therefore an intuitive and easy-to-understand stimulus for guiding breathing. For example, the article can undergo inflation and deflation of an internal air bag via the control of a pump. Another example of tactile stimulation is the use of a vibration motor, for example 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 article such as a pillow, such as a more compact actuator.

[0137] It should be noted that in the context of the present disclosure, references to the "phase" of the first user-perceivable stimulation cycle and breathing cycle at a given time refer to the portion of the cycle covered up to the 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 the given point in time. In general, the phase can be mathematically represented by a single variable parameter φ, which 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 determined by φ t =(φ_max / T)*t+φ 偏移 It is concluded that, 偏移 is the offset or starting phase of the cyclic pattern.

[0138] As mentioned above, in some embodiments, the processing device 32 is further adapted to perform a response action based on the synchronization state. There are different options in terms of the response action. One general approach is to take measures to adjust the phase of the first user-perceivable stimulus to improve the synchronization state. Another general approach is to communicate the synchronization state to the user to help the user improve synchronization.

[0139] Figure 3 The steps of an exemplary method according to the first general method are summarized in block diagram form in FIG. Figure 2 In addition to the steps outlined in , the method comprises the additional step of performing 60 one or more adjustments of the current cyclic phase of the first user-perceivable stimulus so as to align it with the user's current breathing phase (or at least improve the alignment, i.e. align it closer to the user's current breathing phase). In other words, a responsive action comprising the one or more adjustments described above is performed.

[0140] As mentioned above, preferably, the processing device can be adapted to configure the initial cyclic phase of the first user-perceivable stimulus based on the user's breathing phase. For example, this can be performed at device startup, or when starting a paced breathing guide. This ensures that the stimulus starts with alignment with the user's breathing phase. For example, the processing device 32 can be adapted to perform a startup routine comprising: monitoring the breathing phase for multiple breathing cycles of the user based on processing of input sensor signals from physiological sensors; starting generation of the first user-perceivable stimulus; and wherein the first user-perceivable stimulus starts at the starting phase of its cyclical pattern, and wherein the starting phase is set to match the current cyclic phase of the user's breathing cycle at the start.

[0141] After initiation, one or more adjustments may be made to the phase of the first user-perceivable stimulus. In other words, one or more additional adjustments may be made after the first user-perceivable stimulus has begun, based on monitoring of the user's breathing (or respiration) cycle throughout the operation. The one or more adjustments may be performed at repetitive or repeated time points throughout the operation cycle. 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.

[0142] Figure 4 An example process of adjusting the phase φ of an example first user-perceptible stimulus is schematically illustrated.

[0143] Figure 4(a) shows a waveform 72 of an example first user-perceivable stimulus. The waveform indicates a cyclic patterning of the first user-perceivable stimulus. For example, the waveform represents the intensity that varies over time as the stimulus is generated, thereby guiding the user to regulate their breathing according to the cyclically patterned stimulus. Figure 4 (a) further shows a waveform 74 of the user's breathing changing over time. Figure 4 (a) indicates the initial time point t0, at which the stimulation and the user's breathing cycle are in phase.

[0144] 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.

[0145] 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 shifting the phase of the first user perceptible stimulus by a phase difference or phase shift Δφ to thereby 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, and waveform 72b indicates the first user perceptible stimulus waveform after the phase adjustment.

[0146] Figure 4 (d) shows the waveform 72 of the first user perceptible stimulus after the phase adjustment at time t1. The first user perceptible stimulus then continues with the same patterning and frequency as before, but with the phase at time t1 aligned with the phase of the breathing cycle.

[0147] It should be noted that preferably, the specific cyclical pattern followed by the first user-perceivable stimulus, including, for example, the frequency or period of the stimulus, is set and controlled independently of any phase adjustment that may be performed. To state this more precisely, in some embodiments, the controlled generation of the first user-perceivable stimulus includes controlling the cyclical frequency or period of the first user-perceivable stimulus, and wherein one or more adjustments of the cyclical phase of the first user-perceivable stimulus are performed independently of the control of the cyclical frequency or period of the stimulus. In other words, one or more adjustments of the cyclical phase of the user-perceivable stimulus are performed without changing the underlying period or frequency of the cyclically patterned first user-perceivable stimulus. For example, during the period between the repetitive time points, the first user-perceivable stimulus may be generated at a fixed or independently controlled cyclical frequency.

[0148] It should be noted that in the context of the present disclosure, the terms cycle frequency and cycle period applied to the first user-perceivable stimulus mean the repetition frequency of each cycle of the cyclical pattern embodied by the first user-perceivable stimulus. This may be a smooth sinusoidal pattern, or it may be a pattern of different shapes, such as a skewed pattern to guide 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 ratio of 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 will exhibit a pattern of repeated "units" or "cycles", and the frequency means the repetition frequency of the unit or cycle, and the cycle means the time that an instance of the pattern of the unit or cycle lasts. Phase refers to the portion of the particular cycle currently in progress that has been moved through at a given point in time.

[0149] By way of example, an example implementation of a method according to a set of specific embodiments that the inventors believe to be particularly advantageous can be summarized as including the following steps / features:

[0150] - 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 previously mentioned startup routine.

[0151] - 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.

[0152] - Optionally, the method further comprises monitoring the stability of the user's breathing cycle, and only in response to detecting that the user's breathing is relatively stable, performing one or more adjustments of the above user-perceivable stimulus. This thereby filters out unexpected noise and makes the system more stable overall.

[0153] The overall goal may be to automatically adjust the first user perceptible stimulus to match the inhalation phase or the exhalation phase, but preferably maintain the underlying induction frequency of the first user perceptible stimulus.

[0154] Optional features for configuring the frequency or period of the first user-perceivable stimulation 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.

[0155] 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.

[0156] In some embodiments, as now discussed in more 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.

[0157] According to a particular aspect of the invention, there is provided a processing device for a sleep aid, the sleep aid comprising one or more stimulation generators operable to generate one or more user-perceivable stimulations having one or more sensory modalities, and the sleep aid further comprising a physiological sensor.

[0158] The processing equipment is suitable for:

[0159] receiving an input sensor signal from a physiological sensor;

[0160] controlling generation of a first user perceptible stimulus that is cyclically patterned for guiding a user to match their breathing rhythm to a cyclic phase and cyclic frequency of the first user perceptible stimulus; and

[0161] 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.

[0162] Figure 5 The steps of an example method according to one or more embodiments are summarized in block diagram form. The steps will now be described in general terms and then further explained 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 guide a user to match their breathing rhythm to a cyclic phase and cyclic frequency of the first user-perceivable stimulus; processing physiological sensor signals to determine or monitor 82 a user's heart rate variability (HRV), and setting 84 a frequency of the first user-perceivable stimulus based thereon.

[0163] It should be noted that the order of the steps may be different. For example, step 54 of generating a user perceptible stimulus may only be performed after the cycle frequency has been set so that the first user perceptible stimulus starts with the HRV adaptation frequency. However, the cycle frequency may also be adjusted after the first user perceptible stimulus has started. For example, it may start with a default cycle frequency and be adjusted after it has started.

[0164] The steps of this method can be combined with the steps of any of the other methods described in this disclosure, such as Figure 7 Other methods outlined (to be described later). In addition, Figure 5 The method itself represents an invention, as it itself provides the advantageous technical effect of improving the efficacy of the paced 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, another aspect of the present invention is a computer program product, which includes instructions, which when executed on a processing device, cause the processing device to perform the method.

[0165] As will now be explained in further detail, HRV is an important biomarker for determining optimal parameters for paced breathing.

[0166] The heart rate is not constant, but varies with each heartbeat. In particular, the heart rate increases with the onset of inhalation and decreases as 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 heart rate increases with inhalation and decreases with exhalation.

[0167] Furthermore, the degree of heart rate irregularity varies depending on the state of arousal. When individuals are in a state of tension, their hearts beat more regularly, and when individuals are in a more relaxed state, their hearts beat more irregularly. This can be represented by the parameter of heart rate variability (HRV). Low HRV corresponds to a more tense state. In fact, a persistently low HRV can even be a cause of death. Higher HRV corresponds to a more relaxed state.

[0168] Additionally, a person's breathing rhythm can affect their relaxation level via biofeedback from the cardiovascular system.

[0169] In the context of sleep induction, the goal is to achieve a state of maximum relaxation (a state of minimum arousal or minimum tension). This will correspond to a state of maximum HRV. It is well known that the breathing rhythm can change the degree of tension and relaxation of a person. Therefore, the goal is to set the frequency or period of the cyclically patterned first user-perceivable stimulus so that it guides the user to adopt a (matching) breathing rhythm that induces the highest possible HRV for the user. In other words, the goal 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 this breathing cycle frequency associated with the highest HRV.

[0170] Roughly speaking, this resonant frequency is usually in the range of 4.5-6.5 breaths per minute and varies from one individual to another, and even for the same individual at different times, depending on his / her physiological state.

[0171] 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.

[0172] A program may be included for determining the user's breathing rate associated with the highest HRV.

[0173] The procedure may involve varying the cyclic frequency of the first user-perceptible stimulus, measuring the HRV for each cyclic frequency, and then setting the cyclic frequency of the first user-perceptible stimulus equal to the cyclic frequency consistent with the highest measured HRV amplitude among the different set frequencies.

[0174] For example, a calibration procedure for setting the cyclic frequency of a first user-perceivable stimulus can be implemented, the calibration procedure comprising a series of periods, and wherein: in each respective period, the cyclic frequency of the first user-perceivable stimulus is set to a different respective value; during each period, the physiological sensor signal is processed to determine the user's HRV; the cyclic frequency of the first user-perceivable stimulus is set equal to the cyclic frequency consistent with the highest measured HRV during the calibration procedure.

[0175] For example, different corresponding values ​​of the cyclic frequency in different periods can be set to a frequency that varies within a window that spans a predefined typical range of HRV resonant frequency values ​​for an individual. For example, this can be a window centered around, for example, 5.5 breaths per minute.

[0176] The physiological sensor mentioned above 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. In addition, the respiratory cycle phase can also be derived from the pulse or heart rate sensor. In particular, the beginning of the pulse rate increase is aligned with the beginning of the inhalation phase, and the beginning of the pulse rate decrease is aligned with the beginning of the expiratory phase decrease. In fact, the rising part of the heart rate or pulse rate variation curve (the heart rate or pulse rate changes over time) corresponds to the inhalation phase, and the falling part of the signal corresponds to the expiratory phase. Therefore, with the help of the heart rate signal or the pulse rate signal, the inhalation phase and the expiratory phase can be easily detected. The breathing rate can also be detected by determining the interval frequency of the peaks of the heart rate signal.

[0177] 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 explained above, the frequency of the first user-perceivable stimulation associated with the highest HRV amplitude corresponds to the HRV resonant frequency.

[0178] 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 fixed-pace breathing stimulation device can be implemented.

[0179] The steps associated with setting the cyclic frequency of the first user-perceivable stimulus may be combined with the steps of any of the other methods described in this disclosure or provided by itself. Figure 7The steps of an example method according to one or more embodiments are summarized in block diagram form. The details of each of the steps have been described in this document, and therefore the reader can refer to the relevant paragraphs above for additional 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 their breathing rhythm 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 thereon; 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 further include performing a response action, such as performing 60 one or more adjustments of the cyclic phase of the first user-perceivable stimulus to align it with the user's current breathing phase.

[0180] Steps 82 and 84 may instead be performed prior to commencing generation of the first user-perceptible stimulus, such that the stimulus begins with a cyclic frequency determined based on the HRV.

[0181] 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 are described to aid understanding and provide examples to illustrate the inventive concept.

[0182] In a first step, the user places their finger on a pulse sensor that is integrated into the sleep aid. For example, the sleep aid may include an article that is adapted to come into contact with the user during use, such as a cushion or pillow, and the pulse sensor is integrated into the article and is designed to have a sensitive area that can be physically contacted at the surface of the article. The user breathes at their own pace in this stage.

[0183] The inhalation phase and exhalation phase of the user are detected by the pulse signal, and the start of the first user-perceivable stimulus that is cyclically patterned is started at such a time so as to be synchronized in phase with the inhalation phase or the exhalation phase of the user. For example, in some embodiments (which will 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 the article that is suitable for 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 an airbag integrated in the 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.

[0184] Thus, the start phase of the first user-perceivable stimulation is automatically synchronized with the user's breathing phase. During stimulation, the synchronization can be adjusted, for example by a brief pause in the stimulation, to correct any asynchrony that has occurred. This concept has been described in detail previously.

[0185] The stimulation frequency can then be set to the HRV resonant frequency (see discussion above for more details). As a brief reminder, the HRV resonant frequency can be obtained 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 during this phase they perform practice use. 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, each lasting 2 minutes. As previously described, the corresponding HRV amplitude can be detected for each by the pulse signal. The HRV resonant frequency is the frequency value of the first user-perceivable stimulation that is consistent with the maximum measured HRV amplitude during the calibration phase. During the main phase of operation of the device for sleep induction, this HRV resonant frequency is stored and used as the cyclic frequency of the first user-perceivable stimulation.

[0186] As an alternative to the above, the resonant HRV amplitude can be derived during the main phase of operation for sleep induction. In particular, during the main operation, the frequency of the first user-perceivable stimulation can be varied over a range of different values, for example starting at 5.5 cycles per minute, decreasing after 2 minutes by 0.5 cycles per minute to 5 cycles per minute, and increasing to 6 cycles per minute after another 2 minutes. The stimulation frequency that results in the highest measured HRV frequency within this program 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 initiation occurs.

[0187] The processing device may comprise a memory for storing the determined HRV resonance amplitude value.

[0188] In some embodiments, 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 the onset of the first user-perceivable stimulus is triggered to start in phase with the user's breathing cycle.

[0189] During the main sleep induction operation, the user controls their breathing so as to follow the paced stimulation. After sleep onset, the user's breathing rate will typically begin to increase, for example from about 5.5 breaths per minute during sleep induction to about 15 breaths per minute after sleep onset. At the same time, the heart rate will decrease compared to during the awake state. These two conditions, i.e., increased breathing rate and decreased heart rate, can be used together to detect sleep onset. In response to detecting sleep onset, the processing device can be adapted to stop the first user-perceivable stimulation to avoid disturbing the user's sleep.

[0190] In some embodiments, the frequency of the first user-perceivable stimulus can be gradually adjusted in a phase-synchronized manner during sleep induction. For example, the value of the respiratory frequency of an adult can typically be about 12-18 cycles per minute, while the value of the HRV resonant frequency can typically be about 5.5 cycles per minute. In order not to suddenly jump to a much lower frequency (which may be uncomfortable), a transition phase can 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 frequency) to a value matching the determined target cyclic frequency calculated according to HRV. For example, when the first user-perceivable stimulus begins, it can 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, it is reduced by another 70%, and so on, until the determined target cyclic frequency is reached. The step size, such as the percentage of decrease, can vary, such as 60%, 75%, or 80%, etc. In some examples, it can vary with the step, such as becoming smaller as the target cyclic frequency is approached. The step size may be adjusted manually or automatically.

[0191] As previously discussed, 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 that indicates a state of synchronization between a cyclic phase of the first user-perceivable stimulus and a user's breathing phase. In some embodiments, the sleep aid may further include a second stimulus generator for generating the second user-perceivable stimulus.

[0192] 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 can be compared in all respects to the exemplary sleep aid device 12 except for the additional inclusion of a second stimulation generator 46. Figure 1 This represents only one example. In some embodiments (and as will be further described later), the second user-perceptible stimulus may be generated by the same stimulus generator as the first user-perceptible stimulus.

[0193] 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.

[0194] 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. Figure 8 The processing device 32 configured to perform the method may be provided as a separate aspect of the present invention; and / or Figure 8 The sleep aid 12 including the processing device 32 may be provided as a separate aspect of the present invention. In general, the method comprises the following steps: monitoring 52 a user's breathing phase based on processing of an input sensor signal from a physiological sensor 44; controlling 54 the generation of a first user-perceivable stimulus that is cyclically patterned for guiding the user to match their breathing rhythm with the cyclic phase and cyclic frequency of the first user-perceivable stimulus; determining 56 a 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 that indicates a synchronization state between the cyclic phase of the first user-perceivable stimulus and the user's breathing phase.

[0195] Now, an example implementation of the method according to a set of specific embodiments will be described by way of illustrating the above-summarized concept. It should be understood that not all features of this set of specific embodiments are necessary for the inventive concept, and the description thereof is to help understanding and provide examples to illustrate the inventive concept.

[0196] An individual's normal breathing is cyclical, similar to the tidal cycle, with repetitions of inhalation and exhalation phases.

[0197] Fig.10(Top) shows this breathing cycle variation. 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 106 in breathing before the next inhalation 102 begins. During breathing, the individual periodically experiences pressure changes in a manner similar to the tidal cycle.

[0198] In some embodiments, to simulate such tidal changes in pressure, the first user-perceivable stimulus 54 may be progressively 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 patterning of the stimulus for guiding the user's breathing rhythm.

[0199] Fig.10 (lower figure) shows a waveform 108, which schematically shows an example of a cyclic patterning of a first user-perceivable stimulus according to one or more embodiments. It is shown in phase alignment with the user's breathing cycle (upper figure). Waveform 108 indicates a change in vibration amplitude that changes over time.

[0200] Fig.10 The amplitude variation shown rises linearly during the inhalation phase and decreases linearly 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 vibration amplitude, the user can easily follow the rhythm of the guided stimulation with his eyes closed without disturbing a calm state of mind.

[0201] It should be noted that the above-mentioned method of generating a first user-perceivable stimulus may in fact be implemented as a part of any one of the embodiments described in the present disclosure.

[0202] Continuing with the description of this set of example embodiments, the method further includes monitoring the user's breathing phase 52 while generating the first user-perceivable stimulus. This can be achieved in the manner already discussed above using, for example, a heart rate or pulse rate signal. For example, a PPG sensor is a simple way to obtain such a signal.

[0203] 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 to the user through the second user-perceivable stimulus 92. As previously discussed, it may be the case that although the user is following the correct breathing rate or rhythm, the phase of their breathing cycle may not be synchronized with the phase that guides the first user-perceivable stimulus, or even completely opposite. For example, the stimulus is in the inhalation phase, but the user is in the exhalation phase.

[0204] Different options for providing feedback of the synchronization state to the user are discussed below: it can be generated using a different sensory modality than the first stimulus; it can be generated using the same sensory modality as the first stimulus (e.g., as a modulation of the first stimulus). In some examples, feedback of the synchronization state can be tactile feedback, e.g., with a fixed intensity or a progressive vibration intensity.

[0205] 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 the second stimulus 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.

[0206] For example, this implementation can be understood from the following example case:

[0207] Case 1: The first user-perceivable stimulus is in the inspiratory phase, and the user's breathing is in the inspiratory 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.

[0208] 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, that is, no vibration is fed back to the user, or a different pattern of vibration 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.

[0209] 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.

[0210] 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, that is, no vibration is fed back to the user, or a different pattern of vibration 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.

[0211] 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 their breathing is synchronized with the first user-perceptible stimulus (which guides their paced breathing).

[0212] In the above example implementations, 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 includes an adjustment of a baseline or offset of a cyclical pattern of the first user-perceivable stimulus. In other words, when the stimulus 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 the synchronization state.

[0213] However, it should also be noted that the above implementation for the second stimulus is not limited to use with a first user-perceivable stimulus that is a vibration. For example, the first user-perceivable stimulus may be an optical stimulus or a visual stimulus, or an acoustic stimulus, or a tactile stimulus, such as the expansion / contraction article briefly mentioned above (and further described below).

[0214] For example, in the case where the first user-perceivable stimulus is generated as the expansion / contraction of a pillow, when the user's inhalation is synchronized with the expansion of the pillow, a continuous vibration response (as a second user-perceivable stimulus) may be generated by the vibrator. 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 pattern of vibration is generated to convey the mismatch.

[0215] Thus, following the principles of the above-described specific example implementations, components of a particularly advantageous set of embodiments may include the following: a sleep aid device (e.g., a wristband, handheld device, or hugging device) having a stimulation means for generating a paced stimulation that is used to guide the user to adjust their breathing rhythm, for example by simulating the tendency of inhalation and exhalation with the aid of progressive vibrations.

[0216] Sensors provided on the sleep aid device, such as a PPG sensor, are used to track the user's inhalation and exhalation.

[0217] A tactile feedback means (such as a vibrator) is used to provide continuous feedback as the user's breathing is synchronized with the rhythm of the stimulation.

[0218] Any of the above features or method steps can be combined with or integrated into any of the other methods described in this document. Fig.11 The steps of an example method according to one or more embodiments are summarized in block diagram form. The details of each of the steps have been described in this document, and therefore for additional details, the reader can refer to the relevant paragraphs above. 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 their breathing rhythm 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, which indicates the synchronization state between the cyclic phase of the first user-perceivable stimulus and the user's breathing phase.

[0219] Alternatively, steps 82 and 84 may instead be performed prior to commencing generation 54 of the first user-perceptible stimulus, such that the stimulus begins with a cyclic frequency determined based on the HRV.

[0220] For 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 of the steps have been described in this document, and therefore for additional details, the reader can refer to the relevant paragraphs above. 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 their breathing rhythm 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, which indicates the synchronization state between the cyclic phase of the first user-perceivable stimulus and the user's breathing phase.

[0221] For 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 of the steps have been described in this document, and therefore for additional details, the reader is referred to the relevant paragraphs above. 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 their breathing rhythm 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 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, which indicates the synchronization state between the cyclic phase of the first user-perceivable stimulus and the user's breathing phase.

[0222] It should be noted that in any of the above methods, the step of determining the cyclic frequency of the first user-perceptible stimulus can 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 indicated in each figure is not required, and the order of the steps can vary. For example, the method may include: before starting the first user-perceptible stimulus, first monitoring the physiological sensor signal; determining the user's HRV; monitoring the user's breathing phase; based on the HRV, using the method already described above, determining the cyclic frequency for the stimulation; and starting the first user-perceptible stimulus at the determined cyclic frequency and preferably also at a starting phase that matches the user's breathing phase at the starting point.

[0223] Further optional details relating to the means for generating the first user-perceivable stimulus will now be briefly described, as well as options relating to the structure of the sleep aid device and compatible with any embodiment of the present invention. Furthermore, the advantageous arrangement discussed below represents an invention in itself, as it provides advantageous technical effects that can be achieved independently of the other features already discussed.

[0224] According to one or more embodiments, it is proposed to use an article to generate the previously discussed first user-perceivable stimulus (for guiding the user's paced breathing), which can be held by the user and represents a cyclical motion caused by an actuation mechanism, the cyclical 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.

[0225] Fig.14An example article 112 is shown in the form of a cushion or pillow. The cushion or pillow can be held against the body by the user. This may be referred to as a hug pillow. For example, its contour or shape may be designed to conform to the shape of the body so that it fits comfortably against the body. The user will feel the expansion and contraction of the device and be guided to follow the movement, thereby adjusting the rhythm of their breathing.

[0226] For example, the actuation mechanism may be a pneumatic actuation mechanism, and wherein the first user-perceivable stimulus comprises cyclical inflation and deflation of an air bladder integrated into 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.

[0227] According to one or more embodiments, a system may be provided, the system comprising any of the embodiments discussed above (e.g., according to Figure 1 or Figure 8 ) of an embodiment) and further includes an article as described above for providing a first stimulation generator.

[0228] 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 arrangement according to any embodiment described in this document.

[0229] Now, a preferred implementation of a sleep aid device 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 the description thereof is intended to aid understanding and provide examples to illustrate the inventive concept.

[0230] In this group 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 wherein the physiological sensor is integrated into 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 item that can be held by a user. The article can preferably have a fabric surface and / or be padded at least at its surface. The article is preferably suitable for being held by the user against their body with one or more hands, i.e., grasped or hugged by the user, so that their hands are in continuous contact with the device.

[0231] Regarding physiological sensors, it is proposed to preferably use a PPG sensor arranged to have a sensitive area that can be physically contacted at the surface of the article. This allows the user's heart rate to be continuously monitored while the user holds the article, while inflation and deflation (or other stimulation) provide guidance for the user to adjust their breathing rhythm.

[0232] Heart rate can be used to track the user's breathing phase. In addition, and as already discussed above, in some embodiments, heart rate can be used to determine the HRV biofeedback resonant frequency (meaning the frequency that stimulates the user to exhibit the highest HRV at a steady pace of breathing). The resonant frequency can optionally be used as a target guided breathing frequency for sleep induction.

[0233] As discussed above, in some embodiments, by tracking the breathing phase using the PPG signal, the phase of the first user-perceivable stimulus providing the breathing guidance 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 guidance.

[0234] Optionally, the start and stop of the first user-perceivable stimulus may be automatically triggered according to the sleeping state / awake state of the user.

[0235] Fig.15 , Fig.16 and Fig.17 Advantageous features according to certain one or more embodiments are schematically illustrated in FIG.

[0236] like Fig.15 As shown, it is proposed to provide an integrated physiological parameter sensor 122 for the article 112, and the integrated physiological parameter sensor is arranged with a sensitive area that can be physically contacted at the surface of the article. For example, it is proposed to install a pulse sensor on the surface of the article.

[0237] In addition, if Fig.16 As shown, in some embodiments, it is proposed to provide a pocket or covering element 132 extending over the sensitive area of ​​the sensor 122, which allows the user to put his or her hand 124. For example, the pocket or covering element 132 is attached to the surface of the article, and wherein the sensitive area of ​​the sensor 122 can be physically contacted via the opening of the pocket or covering element.

[0238] like Fig.16 and Fig.17As shown, in some embodiments, the device further includes a finger placement guide 142 for guiding the user to physically place their 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 their finger through the belt or annular band to keep the finger in the appropriate position. More generally, a finger placement guide can be provided, which can provide physical guidance or tactile guidance for guiding the placement of the finger without visual observation by the user. The finger placement guide is preferably suitable for releasably holding the finger in the appropriate position.

[0239] In some embodiments, integrated within the interior space of the article 112 may be an inflatable bladder, such as an inflatable bladder or bag, and a pump for changing the level of inflation 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 via inflation and deflation of the bladder. Thus, the action may provide the first user-perceivable stimulus discussed previously.

[0240] A pillow is an example of a user-friendly unit that can be used as the previously discussed article 112. However, the above implementation is now limited to the use of a pillow. For example, other devices, such as handheld devices, can be used. In addition, expansion / contraction is not required for the first user to perceive the stimulus. Alternatively, other stimulation means, such as light and / or sound, etc., can also be used.

[0241] 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:

[0242] - A sleep inducing device (eg a pillow or a cushion) having stimulation means for generating a first user-perceivable stimulus at a constant rate, such as an air bag or mechanical inflation and deflation means.

[0243] - A PPG sensor mounted on the surface of a pillow or cushion to sense blood pulse through the fingertips.

[0244] - A finger strap or pouch to cover the PPG sensor on the pillow and to guide the finger to position it firmly on the sensor.

[0245] - A microcontroller or processing device to calculate and preferably monitor the user's HRV over time and generate a real-time breathing curve of the user based on the blood pulse signal for tracking the phase of the user's breathing.

[0246] - The same or a different microcontroller or processing device to control the generation of the paced 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).

[0247] Fig.18 A method according to an embodiment of the invention is depicted. The method is for controlling a sleep aid device 12. The sleep aid device 12 includes one or more stimulus generators 42 operable to generate user-perceivable stimuli having one or more sensory modalities to guide a user 46 to match a breathing rhythm of the user 46 to a cyclic frequency of the user-perceivable stimuli. The sleep aid device 12 further includes at least one physiological sensor 44 operable to generate sensor data. The method includes steps 1301-1306. Step 1301 includes receiving sensor data from at least one physiological sensor. Step 1302 includes determining a breathing phase of the user based on the sensor data. Step 1303 includes determining a heart rate variability (HRV) of the user based on the sensor data. Step 1304 includes providing a control signal to the one or more stimulus generators to generate a plurality of user-perceivable stimuli, each of the plurality of user-perceivable stimuli having a different cyclic frequency. Step 1305 includes determining a heart rate variability for each of the different cyclic frequencies. Step 1306 includes providing another control signal to one or more stimulation generators to generate a first user-perceivable stimulation based on the respiratory phase and the determined heart rate variability.

[0248] The method optionally includes step 1307: determining a cycle frequency corresponding to the highest heart rate variability among different cycle frequencies, and after determining the cycle frequency corresponding to the highest heart rate variability, providing another control signal based on the cycle frequency corresponding to the highest heart rate variability.

[0249] The method optionally includes determining a synchronization state between a cyclic phase of the first user-perceptible stimulus and a respiratory phase of user 46, and performing a response action based on the synchronization state, and wherein the response action includes performing one or more adjustments of the cyclic phase of the first user-perceptible stimulus to align with a current respiratory phase of user 46. The one or more adjustments are performed at repetitive time points / repeated time points.

[0250] The method optionally includes determining a synchronization state between a cyclic phase of the first user-perceptible stimulus and a breathing phase of the user 46, and performing a response action based on the synchronization state, and wherein the response action includes providing a second control signal to at least one of the stimulus generators to generate a second user-perceptible stimulus indicating a synchronization state between a cyclic phase of the first user-perceptible stimulus and a breathing phase of the user. The second user-perceptible stimulus includes a stimulus that is continuously generated when the breathing phase of the user is synchronized with the cyclic phase of the first user-perceptible stimulus, and is not generated when the breathing phase of the user is not synchronized with the cyclic phase of the first user-perceptible stimulus.

[0251] The second user perceptible stimulus optionally comprises a vibration stimulus.The method optionally comprises, when the breathing phase of the user is synchronized with the cyclic phase of the first user perceptible stimulus, adjusting the amplitude of the vibration to modulate the amplitude of the vibration synchronously with the breathing phase of the user.

[0252] In one embodiment, the sleep aid 12 includes: one or more stimulus generators 42 operable to generate user-perceivable stimuli having one or more sensory modalities; at least one physiological sensor 44; and a sensor adapted to perform Fig.18 The method of processing device 36.

[0253] For example, the sleep aid 12 includes an article 112 for physical contact with a user during sleep induction; and the physiological sensor 44 is integrated into the article 112. For example, the article is padded at least at a surface of the article. For example, the article is a pillow or a cushion.

[0254] In one embodiment, at least one physiological sensor 44 is arranged to have a sensitive area that can be physically contacted at the surface of the article 112, and wherein the sensitive area is covered by a pocket or cover element 132 extending over the sensitive area, wherein the pocket or cover element 132 is attached to the surface of the article 112, and wherein the sensitive area is physically contactable via an opening of the pocket or cover element 132. Optionally, the physiological sensor is a PPG sensor. Optionally, the first user-perceivable stimulus is a tactile or haptic stimulus and includes a cyclic motion caused by an actuation mechanism.

[0255] In one embodiment, the present invention is a computer program product comprising instructions which, when executed on a processing device 36, cause the processing device 36 to perform a method according to the seventh aspect.

[0256] Any of the 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, and the treatment device may be according to any of the above embodiments. The article 122 may be combined with any of the treatment devices already described above.

[0257] As mentioned previously, the present invention can be embodied in software form. Therefore, another aspect of the present invention is a computer program product comprising code means, which, when run on a processor, 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.

[0258] The embodiments of the present invention described above employ processing equipment. The processing equipment may generally include a single processor or multiple processors. It may be located in a single containing device, structure or unit, or it may also be distributed between multiple different devices, structures and units. Therefore, references to processing equipment adapted or configured to perform a particular step or task may correspond to steps or tasks performed by any one or more of a plurality of processing components individually or in combination. Those skilled in the art will appreciate how such distributed processing arrangements may be implemented. The processing equipment may include a communication module or input / output for receiving data and outputting data to another component.

[0259] 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 certain functions and one or more programmed microprocessors and associated circuitry that performs other functions.

[0260] Examples of circuit devices 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).

[0261] 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, when executed on one or more processors and / or controllers, may perform the desired functions. 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.

[0262] Variations to the disclosed embodiments may be understood and effected by those skilled in the art in practicing the claimed invention, through a study of the drawings, the 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.

[0263] A single processor or other unit may fulfill the functions of several items recited in the claims.

[0264] 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.

[0265] The computer program may be stored / distributed on a suitable medium, such as an optical storage medium or solid-state medium 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 telecommunication systems.

[0266] If the term "adapted to" is used in the claims or the specification, it should be noted that the term "adapted to" is intended to be equivalent to the term "configured to".

[0267] Any reference signs in the claims should not be construed as limiting the scope.

Claims

1. A method for controlling a sleep aid device, The sleep aid (12) includes one or more stimulation generators (42) operable to generate user-perceivable stimulation having one or more sensory modalities to guide a user (46) to match the rhythm of the user's (46) breathing to a cyclical frequency of the user-perceivable stimulation, and the sleep aid (12) further includes at least one physiological sensor (44) operable to generate sensor data, The method comprises: receiving the sensor data from the at least one physiological sensor (44); determining a breathing phase of the user based on the sensor data; determining a heart rate variability (HRV) of the user based on the sensor data; providing a control signal to the one or more stimulus generators (42) to generate a plurality of user-perceivable stimuli, each of the plurality of user-perceivable stimuli having a different cycle frequency; determining the heart rate variability for each of the different cycling frequencies; Based on the respiratory phase and the determined heart rate variability, an additional control signal is provided to the one or more stimulation generators to generate a first user-perceivable stimulus (72).

2. The method according to claim 1, comprising: determining a cycle frequency corresponding to a highest heart rate variability among the different cycle frequencies, After determining the cyclic frequency corresponding to the highest heart rate variability, the further control signal is provided based on the cyclic frequency corresponding to the highest heart rate variability.

3. The method according to claim 1 or 2, comprising: Determine a synchronization state between a cyclic phase of the first user-perceivable stimulus (72) and the breathing phase of the user, and perform a response action based on the synchronization state, and wherein the response action includes: performing one or more adjustments to the cyclic phase of the first user-perceivable stimulus (72) so as to align with the current breathing phase of the user.

4. The method according to claim 3, The one or more adjustments are performed at repeated time points.

5. The method according to any one of claims 1 to 4, comprising: Determining a synchronization state between the cyclic phase of the first user-perceivable stimulus (72) and the breathing phase of the user, and performing a response action based on the synchronization state, and wherein the response action includes providing a second control signal to at least one of the stimulus generators to generate a second user-perceivable stimulus, the second user-perceivable stimulus indicating the synchronization state between the cyclic phase of the first user-perceivable stimulus (72) and the breathing phase of the user.

6. The method of claim 5, wherein the second user-perceivable stimulus comprises a stimulus: continuously generating the stimulus while the breathing phase of the user is synchronized with the cyclic phase of the first user-perceptible stimulus (72); and When the breathing phase of the user is not synchronized with the cyclic phase of the first user-perceptible stimulus (72), the stimulus is not generated.

7. The method according to claim 6, wherein The second user-perceivable stimulus comprises a vibration stimulus, and The method comprises: When the breathing phase of the user is synchronized with the cyclic phase of the first user-perceptible stimulus (72), the amplitude of the vibration is modulated in synchronization with the breathing phase of the user.

8. A sleeping aid device (12), comprising: one or more stimulus generators operable to generate user-perceivable stimuli having one or more sensory modalities; at least one physiological sensor; as well as Processing equipment adapted to perform the method according to any one of claims 1 to 7.

9. The sleeping aid (12) of claim 8, comprising an article for physical contact with a user during sleep induction; and Wherein the physiological sensor is integrated into the article.

10. The sleeping aid device (12) according to claim 9, wherein the article is cushioned at least at a surface of the article.

11. The sleeping aid (12) of claim 9, wherein the article is a pillow or a cushion.

12. The sleeping aid device (12) according to any one of claims 9 to 11, wherein the at least one physiological sensor is arranged to have a sensitive area that can be physically contacted at the surface of the article, and wherein the sensitive area is covered by a pocket or a covering element extending over the sensitive area, wherein the pocket or the covering element is attached to the surface of the article, and wherein the sensitive area can be physically contacted via an opening of the pocket or the covering element.

13. The sleeping aid device (12) according to any one of claims 8 to 12, wherein the physiological sensor is a PPG sensor.

14. A sleeping aid (12) according to any one of claims 8 to 13, wherein the first user-perceivable stimulus (72) is a tactile or haptic stimulus and comprises a cyclical motion caused by an actuation mechanism.

15. A computer program product comprising instructions which, when executed on a processing device (32), cause the processing device (32) to perform the method according to any one of claims 1 to 7.

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