RECRUITINGOBSERVATIONAL

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

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 willing to sign a consent form form. - Participants unable to cooperate with the required examinations. - Participants with any other conditions deemed unsuitable for inclusion by the investigators. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DIAGNOSTIC_TEST

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.

Locations (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China