RecruitingNot ApplicableNCT04885062

Belun Ring Platform With an Improved Algorithm for OSA Assessment

Belun Ring Platform (BLS-100) Home Sleep Apnea Testing Device With an Improved Algorithm for Assessment of Obstructive Sleep Apnea: A Comparison to In-Lab Polysomnography

Sponsor

Belun Technology Company Limited

Enrollment

100 participants

Start Date

Feb 1, 2021

Study Type

INTERVENTIONAL

Conditions

Sleep-Disordered Breathing Sleep Architecture

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

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

Exclusion Criteria7

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.

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Interventions

DEVICEBelun Ring

The Belun Ring sensor will be applied to the proximal phalanx of the index finger in the non-dominant hand of the participating individuals prior to their sleep onset in the sleep lab and will be removed upon awakening at the end of the sleep period on the following morning. The attended in-lab sleep study will be performed simultaneously in a standard fashion.

DIAGNOSTIC_TESTPSG

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.