N/A N=136 Diagnostic

Belun Ring Platform With an Improved Algorithm for OSA Assessment

Sleep-Disordered Breathing · Sleep Architecture

Bottom Line

View on ClinicalTrials.gov: NCT04885062 ↗

Enrolled (actual)

136

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: To Evaluate the Ability of the Belun Ring Pulse Oximeter to Gauge the Apnea-Hypopnea Index (AHI) — -1.0 events per hour

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Belun Ring (Device); PSG (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Belun Technology Company Limited
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY To Evaluate the Ability of the Belun Ring Pulse Oximeter to Gauge the Apnea-Hypopnea Index (AHI)	-1.0	—
SECONDARY Sleep Stage Parameters	88; 82; 90	—

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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04885062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.