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Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea
Sponsor: Belun Technology Company Limited
Summary
The purpose of this study is to evaluate the sensitivity and specificity of the Belun Ring Pulse Oximetry system for screening of obstructive sleep apnea (OSA) in adults during standard polysomnography sleep study conditions. The primary outcome metric is the Apnea-Hypopnea Index (AHI). The goal, in its entirety, is to evaluate the performance of the Belun Ring Pulse Oximeter during a standard polysomnography sleep study and its ability to compare to the determined Apnea-Hypopnea Index (AHI) of the subjects. It is expected that the Belun Ring Pulse Oximeter will adequately record SpO2, pulse rate, body position and heart rate variability throughout the duration of the study.
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2018-03-01
Completion Date
2019-05-30
Last Updated
2026-05-26
Healthy Volunteers
Yes
Conditions
Interventions
Belun Ring Pulse Oximeter
Belun Ring Pulse Oximeter allows measurement and analysis of oximetry, pulse rate, photo-plethysmography (PPG), and accelerometer signals from the proximal phalanx of index finger. Total sleep time (Ring-TST) and respiratory event index (Ring-REI) are estimated
Locations (1)
Mountain Sleep Diagnostics
Denver, Colorado, United States