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

Sleep Apnea, Obstructive Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04121923
Study type Interventional
Source Belun Technology Company Limited
Contact
Status Completed
Phase N/A
Start date March 1, 2018
Completion date May 30, 2019
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