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

Launched by SHANGHAI 6TH PEOPLE'S HOSPITAL · Mar 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a new device called the Five Seasons Sleep Tracking Mat to help diagnose a condition known as Obstructive Sleep Apnea (OSA). OSA is a sleep disorder where breathing repeatedly stops and starts during sleep, often causing loud snoring and daytime sleepiness. The trial aims to compare how well this new sleep mat works against the traditional method of diagnosis, which involves a more complex test called polysomnography (PSG).

To participate in this study, individuals aged 18 to 70 who experience symptoms like snoring, feeling excessively sleepy during the day, or poor sleep quality may be eligible. However, those with serious health issues, certain medications that affect sleep, or other sleep disorders will not be able to join. Participants will spend a night at the testing facility where both the sleep mat and the PSG will be used to gather important information about their sleep patterns. The results will help determine if the sleep mat can be a reliable alternative for diagnosing OSA.

Gender

ALL

Eligibility criteria

• 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.