CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 113 enrolled
Drug / intervention
Belun Ring +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03997916
NCT03997916N/ACompleted
CompareCT.gov

A Validation Investigation of the Accuracy of the Belun Ring, an Innovative Single-channel Four-signal Pulse Oximetry, in Patients Referred to Sleep Lab for Assessment of Obstructive Sleep Apnea

University Hospitals Cleveland Medical Center·interventional·Posted Jun 25, 2019·Updated Jan 19, 2023

In Brief

A clinical study evaluating Belun Ring and PSG for Obstructive Sleep Apnea. Completed, enrolled 113 participants across 2 sites.

Detailed Summary

This study aims to determine the overall accuracy, sensitivity, and specificity of the Belun Ring device in evaluating obstructive sleep apnea by comparing the device to the attended overnight in-lab polysomnography which is the gold standard for diagnosis of obstructive sleep apnea. Our hypothesis is that the Belun-Ring, a type 4 portable monitoring device, is overall sensitive and specific for evaluation of obstructive sleep apnea when compared to the attended overnight in-lab polysomnography.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea
CountriesUnited States
CollaboratorsBelun Technology Company Limited

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 25, 2019
Enrollment StartMay 6, 2019
Primary CompletionJun 30, 2019
Study CompletionJul 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.0 years ago

Interventions

Belun Ringdevice

All patients scheduled for attended overnight in-lab polysomnography (PSG) in our 2 sleep labs will undergo PSG testing. On the same night of the PSG testing, these same patients will also wear the Belun Ring device. After the study, we will compare results of the Belun Ring device vis-à-vis with the results of the PSG on the same patient.

PSGother

All patients scheduled for attended overnight in-lab polysomnography (PSG) in our 2 sleep labs will undergo PSG testing. On the same night of the PSG testing, these same patients will also wear the Belun Ring device. After the study, we will compare results of the Belun Ring device vis-à-vis with the results of the PSG on the same patient.