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EP-4547303-B1 - A SLEEP AID APPARATUS AND CONTROL THEREOF

EP4547303B1EP 4547303 B1EP4547303 B1EP 4547303B1EP-4547303-B1

Inventors

  • SHI, JUN

Dates

Publication Date
20260513
Application Date
20230620

Claims (12)

  1. A sleep-aid apparatus (12) comprising: one or more stimulus generators (42) operable to generate a first user-perceptible stimulus, which is cyclically patterned, with one or more sensory modalities to guide a user (46) in matching a pacing of breathing of the user (46) to a cycle phase and a cycle frequency of the first user-perceptible stimulus; at least one physiological sensor (44) operable to generate sensor data; and a processing device adapted to perform a method comprising: receiving the sensor data from the at least one physiological sensor (44); determining a respiration phase of the user based on the sensor data; determining a heart rate variability (HRV) of the user based on the sensor data; varying the cycle frequency of a first user-perceptible stimulus (72); measuring the heart rate variability for each cycle frequency of the first user-perceptible stimulus; setting the cycle frequency of the first user-perceptible stimulus equal to the cycle frequency coincided with a highest measured HRV amplitude; determining a synchronization status between a cycle phase of the first user-perceptible stimulus (72) and the respiration phase of the user; and performing a response action based on the synchronization status, wherein the response action comprises performing one or more adjustments of the cycle phase of the first user-perceptible stimulus (72) so as to align with a current respiration phase of the user.
  2. The sleep-aid apparatus (12) of claim 1, wherein cycle frequency coincided with a highest measured HRV amplitude is a resonant HRV frequency.
  3. The sleep-aid apparatus (12) of claim 1, wherein the one or more adjustments are performed at recurrent/repeating time points.
  4. The sleep-aid apparatus (12) of any one of the preceding claims, wherein the response action comprises providing a second control signal to at least one of the stimulus generators to generate a second user-perceptible stimulus indicative of the synchronization status between the cycle phase of the first user-perceptible stimulus (72) and the breathing phase of the user.
  5. The sleep-aid apparatus (12) of claim 4, wherein the second user-perceptible stimulus comprises a stimulus which is: continuously generated when the respiration phase of the user is synchronized with the cycle phase of the first user-perceptible stimulus (72); and not generated when the respiration phase of the user is non-synchronized with the cycle phase of the first user-perceptible stimulus (72).
  6. The sleep-aid apparatus (12) of claim 5, wherein the second user-perceptible stimulus comprises a vibration stimulus, and wherein the method comprises, when the respiration phase of the user is synchronized with the cycle phase of the first user-perceptible stimulus (72), modulating an amplitude of the vibration in synchrony with the respiration phase of the user.
  7. The sleep-aid apparatus (12) of claim 6, comprising an article for making physical contact with a user during sleep induction; and wherein the physiological sensor is integrated in the article.
  8. The sleep-aid apparatus (12) of claim7, wherein the article is cushioned at least at a surface of the article.
  9. The sleep-aid apparatus (12) of claim 8, wherein the article is a pillow or a cushion.
  10. The sleep-aid apparatus (12) of any of claims 6-9, wherein the at least one physiological sensor is arranged so as to have a sensitive area accessible to physical contact at a surface of the article, and wherein said sensitive area is covered by a pocket or cover element extending over the sensitive area, wherein the pocket or cover element is attached to a surface of the article, and wherein the sensitive area is accessible to physical contact via an opening of the pocket or cover element.
  11. The sleep-aid apparatus (12) of any of claims 6-10, wherein the physiological sensor is a PPG sensor.
  12. The sleep-aid apparatus (12) of any of claims 6-11, wherein the first user-perceptible stimulus (72) is a tactile or haptic stimulus and comprises a cyclical motion induced by an actuation mechanism.

Description

FIELD OF THE INVENTION This invention relates to the field of sleep aid devices, for example sleep aid devices for aiding sleep induction. BACKGROUND OF THE INVENTION One-third of the general adult population reports symptoms of insomnia. It is a major public health concern and may lead to loss of concentration, memory, and performance, as well as physical disease. Current pharmaceutical treatments can be expensive, unhealthy, and habit-inducing. Latest studies, referenced below, have showed that slow paced breathing practiced by an individual at the time of attempting to sleep helps to improve sleep onset and sleep quality. This has led to development of products aimed at inciting individuals to follow particular (slow) breathing rhythms. This concept generally is known as paced-breathing. Various solutions exist to help individuals with paced breathing such as paced breathing Apps, paced breathing videos, and other means. This new area of development opens new possibilities for further improvement and optimization, and for new improved solutions to the general problem. Reference is made to: H J Tsai, Efficacy of paced breathing for insomnia: enhances vagal activity and improves sleep quality, Psychophysiology. 2015 Mar; 54(3):388-96. Reference is made to: Sylvain Laborde, Influence of a 30-Day Slow-Paced Breathing Intervention Compared to Social Media Use on Subjective Sleep Quality and Cardiac Vagal Activity, J Clin Med. 2019 Feb; 8(2): 193. US patent application US 2012/0277521A1 discloses a system comprising a sensor for detecting physiological information of a target, an input module for processing the physiological information, and an output module. The physiological information comprises heart rate variability. The output module generates a audio, visual or mechanical signal. US patent application US 2022/0175309 A1 discloses a therapy provided to a user by analyzing biometrics and guiding breathing to a Resonance Frequency, and providing feedback on stress level. Article "Using breath-like cues for guided breathing", by G. Marentakis et.al, Extended abstracts of the 2021 Chi conference on human factors in computing systems, May 8, 2021, pages 1-7, discloses a breathing exercise using auditory feedback stimuli. US patent application US 2020/0338303 A1 discloses a sleep induction device including a sensor for detecting a physiological characteristic of the user, and a stimulator configured to provide stimuli to the user. United states patent application US 2022/0152340 A1 discloses a haptic respiration simulator including a pump unit, and an accumulator for reducing noise originating from a pumping action of the pump. SUMMARY OF THE INVENTION This disclosure outlines a number of developments devised by the inventor in the area of paced breathing aimed at addressing one or more shortcomings in the existing state of the art which have been newly recognized by the inventors. Within current solutions, generally a sensory stimulus is generated which is rhythmically patterned with a certain frequency, and wherein the user is instructed to adjust the pace of their breathing to follow the pace of the stimulus. One shortcoming identified by the inventors is that the phase of the guiding stimulus may mismatch with the user's respiration phase. The phase might typically be fixed when the device is powered on and not aligned with the user's inhalation phase. Users therefore need to suddenly adjust their inhalation and exhalation phase to get in sync with the phase of periodic stimulus, for example by cutting short a breath to start a new breath or holding their breath longer than would otherwise be comfortable. This causes the user to feel discomforted and nervous, and indeed prompts an involuntary physiological response of anxiety which is contrary to the intended aim of relaxation for sleep. Also, in some instances, the user may follow the sensory stimulus in the reverse phase. This does not cause an issue for a stimulus cycle which has a 1:1 inhalation to exhalation phase length, case but will decrease the performance for the paced breathing when the inhalation to exhalation phase ratio is not 1:1, for example, 1:2. Another deficiency in the current state of the art identified by the inventors is that known solutions employ a standardized frequency or frequency pattern for the guiding stimulus. However, the breathing pace best associated with sleep onset actually varies from person to person, and even for a single individual, varies over time. It is associated with certain physiological parameters of the user. Therefore a fixed frequency paced breathing guide is non-optimal. Another deficiency in the current state of the art is that the particular sensory modalities currently employed for communicating the breathing guidance are somewhat inapt for the general aim of inducing relaxation and sleep. For example, they typically rely on periodic acoustic stimuli. However, these can in fact be jarring and stress-in