Belun Ring Platform With an Improved Algorithm for OSA Assessment

Completed · Not applicable

Conditions studied: Sleep-Disordered Breathing, Sleep Architecture

In brief

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.

Key facts

Study ID

NCT04885062

Run by

Belun Technology Company Limited

People needed

136

Starts

2021-02-01

Expected to finish

2022-06-30

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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