Belun Ring Platform With an Improved Algorithm for OSA Assessment

Sleep-Disordered Breathing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04885062
• Other study ID #: STUDY20201259
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2021
• Source: Belun Technology Company Limited
• Contact: Ambrose A Chiang, MD
• Phone: 216-791-3800
• Email: Ambrose.Chiang[@]UHhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Architecture
• Sleep-Disordered Breathing

Intervention

Device:
• Belun 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 Test:
• PSG
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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Belun Technology Company Limited	University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	REI parameters	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.	1 year
Secondary	Sleep stage parameters	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.	1 year