Status:
RECRUITING
Validation of Five Seasons Sleep Tracking Mat for the Diagnosis of Obstructive Sleep Apnea
Lead Sponsor:
Shanghai 6th People's Hospital
Collaborating Sponsors:
West China Hospital
Second Affiliated Hospital of Soochow University
Conditions:
Obstructive Sleep Apnea (OSA)
Eligibility:
All Genders
18-70 years
Brief Summary
This study will evaluate and compare the diagnostic accuracy and effectiveness of the Five Seasons Sleep Tracking Mat with the gold standard, polysomnography.
Detailed Description
Given that obstructive sleep apnea (OSA) imposes a heavy disease burden, conducting effective public screening is regarded as a crucial step in health management and chronic disease prevention. Curren...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06875479
Start Date
April 20 2025
End Date
September 30 2025
Last Update
April 16 2025
Active Locations (1)
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1
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200025