Belun Ring Platform With an Improved Algorithm for OSA Assessment

Not Applicable

Recruiting

• Conditions: Sleep-Disordered Breathing; Sleep Architecture
• Interventions: Device: Belun Ring; Diagnostic Test: PSG

• Registration Number: NCT04885062
• Lead Sponsor: Belun Technology Company Limited

Brief Summary

OSA is commonly diagnosed with either attended in-lab polysomnography (PSG) or unattended home sleep apnea testing (HSAT). The BLS-100 (Belun Technology Company Limited, Hong Kong) is a novel neural network-based HSAT platform consists of a ring shape pulse oximeter sensor, a cradle, and an improved proprietary analytic algorithm. This study investigates the hypothesis that the BLS-100 is a reasonable HSAT device for OSA assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-09
• Study First Posted: 2021-05-13
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-21
• Primary Completion: 2021-08-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Provision of signed and dated informed consent form.
• Age 18-80
• Clinically assessed and suspicious for OSA

Exclusion Criteria

• Full night PAP titration study
• On home O2, noninvasive ventilator, diaphragmatic pacing, or any form of nerve stimulator
• Having atrial fibrillation-flutter, pacemaker/defibrillator, LVEF < 55%, left ventricular assist device (LVAD), or status post cardiac transplantation
• Patients taking narcotics
• Recent hospitalization or recent surgery in the past 30 days
• Unstable cardiopulmonary status on the night of the study judged to be unsafe for sleep study by the sleep tech and/or the on-call sleep physician

An individual who meets the above criteria but fails to have at least 4 hours of technically valid sleep based on BLS-100 in a diagnostic study or at least 3 hours of technically valid sleep during the diagnostic portion of a split night study will be excluded from statistical analyses.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UH-Participant	Belun Ring	Potential participants with suspected OSA will be identified from the schedule of the UH Beachwood and Bolwell sleep labs.Those subjects who satisfy the study inclusion and exclusion criteria will be approached and invited to participate in the study.
UH-Participant	PSG	Potential participants with suspected OSA will be identified from the schedule of the UH Beachwood and Bolwell sleep labs.Those subjects who satisfy the study inclusion and exclusion criteria will be approached and invited to participate in the study.

Primary Outcome Measures

Name	Time	Method
REI parameters	1 year	To determine the overall accuracy, sensitivity, and specificity of the BLS-100 in assessing OSA by comparing to the attended in-lab PSG in individuals referred to the sleep labs with clinical suspicion of OSA.

Secondary Outcome Measures

Name	Time	Method
Sleep stage parameters	1 year	To determine the accuracy of BLS-100 sleep stage parameters to classify the human sleep stage (Wake, REM and Non-REM) by comparing to the classification results of in-lab PSG.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States