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COMPLETED
NCT04121923
NA

Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea

Sponsor: Belun Technology Company Limited

View on ClinicalTrials.gov

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

Interventions

DEVICE

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