NCT04121923

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Belun Technology Company Limited · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-04-15
• Completion: 2019-05-30
• First posted: 2019-10-10
• Last updated: 2019-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study