Status:
UNKNOWN
A Clinical Trial Evaluating the Effectiveness and Safety of a mmWave Radar Based Sleep Respiratory Monitoring System
Lead Sponsor:
Changsha Tsingray Technology Co., Ltd.
Conditions:
Sleep Breathing Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study compares the diagnostic capability of a millimeter-wave radar-based Sleep Respiratory Monitoring System to the gold standard polysomnography.
Detailed Description
The gold standard for the diagnosis of sleep breathing disorders is polysomnography (PSG), which requires contact sensors, in-lab monitoring and manual scoring by experts, limiting the comfortability ...
Eligibility Criteria
Inclusion
- Participants is 18 years of age or older.
- Participants is willing to undergo overnight polysomnography and Sleep Respiratory Monitoring System testing.
Exclusion
- Participants with severe cardiovascular and cerebrovascular diseases, severe liver, kidney, and lung dysfunction.
- Participants with unstable respiratory diseases, or other diseases in acute phase.
- Long-term or current use of barbiturates, benzodiazepines, sedatives and other drugs that may affect sleep.
- Participants that undergo CPAP treatment during the night of the trial.
- Participants with other sleep disorders, e.g. insomnia.
- Participants with mental disorders.
- Participants that refuse to sign informed consents.
- Participants unable to cooperate with medical examination.
- Participants excluded in the opinion of the investigator.
Key Trial Info
Start Date :
July 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06038006
Start Date
July 13 2023
End Date
November 1 2023
Last Update
September 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200025