Belun Ring Platform (BLS-100) Home Sleep Apnea Testing Device With an Improved Algorithm for Assessment of Obstructive Sleep Apnea: A Comparison to In-Lab Polysomnography
Status: Completed
Location: See location...
Intervention Type: Device, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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 network-based HSAT platform consists of a ring shape pulse oximeter sensor, a cradle, and an improved proprietary analytic algorithm. This study investigates the hypothesis that the BLS-100 is a reasonable HSAT device for OSA assessment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Provision of signed and dated informed consent form.
• Age 18-80
• Clinically assessed and suspicious for OSA
Locations
United States
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Time Frame
Start Date: 2021-02-01
Completion Date: 2022-06-30
Participants
Target number of participants: 136
Treatments
Experimental: UH-Participant
Potential participants with suspected OSA will be identified from the schedule of the UH Beachwood and Bolwell sleep labs.Those subjects who satisfy the study inclusion and exclusion criteria will be approached and invited to participate in the study.
Related Therapeutic Areas
Sponsors
Leads: Belun Technology Company Limited
Collaborators: University Hospitals Cleveland Medical Center