Validation of Five Seasons Sleep Tracking Mat for the Diagnosis of Obstructive Sleep Apnea
Launched by SHANGHAI 6TH PEOPLE'S HOSPITAL · Mar 9, 2025
Trial Information
Current as of April 22, 2025
Recruiting
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.
About Shanghai 6th People's Hospital
Shanghai 6th People's Hospital is a leading medical institution in China, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital focuses on a wide range of therapeutic areas, striving to enhance patient outcomes and contribute to medical knowledge. With a dedicated team of experienced researchers and clinicians, Shanghai 6th People's Hospital emphasizes rigorous scientific methodology and ethical standards, ensuring that all trials are conducted with the utmost integrity and patient safety in mind. Through collaboration with various stakeholders, the hospital aims to bridge the gap between clinical research and real-world application, ultimately improving healthcare delivery both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported