Status:
RECRUITING
Belun Ring Platform With an Improved Algorithm for OSA Assessment
Lead Sponsor:
Belun Technology Company Limited
Collaborating Sponsors:
University Hospitals Cleveland Medical Center
Conditions:
Sleep-Disordered Breathing
Sleep Architecture
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
OSA is commonly diagnosed with either attended in-lab polysomnography (PSG) or unattended home sleep apnea testing (HSAT). The BLS-100 (Belun Technology Company Limited, Hong Kong) is a novel neural n...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form.
- Age 18-80
- Clinically assessed and suspicious for OSA
Exclusion
- Full night PAP titration study
- On home O2, noninvasive ventilator, diaphragmatic pacing, or any form of nerve stimulator
- Having atrial fibrillation-flutter, pacemaker/defibrillator, LVEF \< 55%, left ventricular assist device (LVAD), or status post cardiac transplantation
- Patients taking narcotics
- Recent hospitalization or recent surgery in the past 30 days
- Unstable cardiopulmonary status on the night of the study judged to be unsafe for sleep study by the sleep tech and/or the on-call sleep physician
- An individual who meets the above criteria but fails to have at least 4 hours of technically valid sleep based on BLS-100 in a diagnostic study or at least 3 hours of technically valid sleep during the diagnostic portion of a split night study will be excluded from statistical analyses.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04885062
Start Date
February 1 2021
End Date
June 30 2022
Last Update
July 21 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106