Belun Ring Platform With an Improved Algorithm for OSA Assessment

Not Applicable

Recruiting

• Conditions: Sleep-Disordered Breathing; Sleep Architecture

• 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

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