Validation of Five Seasons Sleep Tracking Mat for the Diagnosis of Obstructive Sleep Apnea

NCT06875479 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai 6th People's Hospital

Phase

Observational

Started

2025-04-20

Last updated

2025-04-16

Condition(s) studied

Obstructive Sleep Apnea (OSA)

Investigational drug(s) / intervention(s)

Five Seasons [5S] Sleep Tracking Mat

Five Seasons [5S] Sleep Tracking Mat: The Five Seasons \[5S\] Sleep Tracking Mat consists of a main control box, monitoring mat, temperature/humidity sensor, power adapter, and light sensor. It utilizes Ballistocardiogram (BCG) technology to detect heartbeat, respiration, body movements, and snoring. The collected data is analyzed by a proprietary pre-trained AI model, enabling automatic detection of respiratory events, calculation of the Apnea-Hypopnea Index (AHI), and sleep stage interpretation. Compared to other sleep monitoring devices, it is non-contact and requires no wearable components, making it particularly suitable for long-term, daily home use.

Study summary

This study will evaluate and compare the diagnostic accuracy and effectiveness of the Five Seasons Sleep Tracking Mat with the gold standard, polysomnography.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * Participants between 18 and 70 years, with potential symptoms of snoring at night, daytime sleepiness, or self-reported poor sleep quality, suspected of having OSA. * Participants who are willing to undergo overnight PSG. Exclusion Criteria: * Participants with presence of severe cardiovascular or cerebrovascular diseases, or significant impairment of liver, kidney, or lung function. * Participants with concurrent unstable respiratory diseases or other acute-phase respiratory illnesses. * Participants using, at long term or currently, barbiturates, benzodiazepines, sedatives, or other medications that may affect sleep. * Participants undergoing continuous positive airway pressure (CPAP) therapy or other sleep-related treatments on the study night. * Participants coexisting insomnia, parasomnia, or other sleep disorders. * Participants with psychiatric disorders. * Participants refusing to sign the informed consent form. * Participants unable to cooperate with the required examinations. * Participants with any other conditions deemed unsuitable for inclusion by the investigators.

Primary outcome measure(s)

Diagnostic sensitivity (AHI = 5) of 5S Sleep Tracking Mat compared to PSG — Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 5 events per hour according to 5S Sleep Tracking Mat in participants with AHI ≥ 5 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of 5S Sleep Tracking Mat will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
Diagnostic specificity (AHI = 5) of 5S Sleep Tracking Mat compared to PSG — Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 5 events per hour according to 5S Sleep Tracking Mat in participants with AHI ≥ 5 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of 5S Sleep Tracking Mat will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.

Trial sites (1)

Facility	City	Region	Status
Shanghai Sixth People's Hospital	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06875479 on ClinicalTrials.gov ↗ ← All trials in China