Evaluating a Sleep Tracking Mat for Diagnosing Sleep Apnea
Validation of Five Seasons Sleep Tracking Mat for the Diagnosis of Obstructive Sleep Apnea
This study is testing a new sleep tracking mat to see if it can accurately diagnose sleep apnea in a simpler and more convenient way than traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai 6th People's Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06875479 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the diagnostic accuracy of the Five Seasons Sleep Tracking Mat in comparison to the traditional method of polysomnography for diagnosing obstructive sleep apnea (OSA). The study addresses the challenges of current diagnostic methods, which are often costly and inconvenient for patients. By utilizing a non-invasive device that monitors vital signs and movements during sleep, the research seeks to improve patient compliance and facilitate large-scale screening for OSA. Participants will be monitored overnight using both the tracking mat and polysomnography to validate the effectiveness of the new device.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 who exhibit symptoms of snoring, daytime sleepiness, or poor sleep quality and are suspected of having OSA.
Not a fit: Patients with severe cardiovascular or respiratory diseases, or those currently undergoing treatment for sleep disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accessible and efficient method for diagnosing obstructive sleep apnea, improving patient outcomes.
How similar studies have performed: Other studies have explored innovative sleep monitoring technologies, but the specific approach of this study using the Five Seasons Sleep Tracking Mat is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Sixth People's Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Weijun Huang, Dr.
- Email: hellohuangwj@126.com
- Phone: 86 18930174480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.