Belun Ring Platform With an Improved Algorithm for OSA Assessment

Belun Technology

Status: Enrolling

Conditions: Sleep-Disordered Breathing; Sleep Architecture

Treatments: Diagnostic Test: PSG; Device: Belun Ring

Study type: Interventional

Funder types: Other

Identifiers

NCT04885062

STUDY20201259

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

UH-Participant

Experimental group

Description:

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.

Treatment:

Diagnostic Test: PSG

Device: Belun Ring