RecruitingNCT06875479

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

Sponsor

Shanghai 6th People's Hospital

Enrollment

400 participants

Start Date

Apr 20, 2025

Study Type

OBSERVATIONAL

Conditions

Obstructive Sleep Apnea (OSA)

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

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 Criteria9

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.

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Interventions

DIAGNOSTIC_TESTFive 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.