Validation of Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor

NCT06255613 | Active Not Recruiting FDA Device

• 1 other identifier: STUDY20231436
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

Brief Summary

Hypothesis: BR's Gen3 DL algorithms, combined with its subxiphoid body sensor, can accurately diagnose OSA, categorize its severity, identify REM OSA and supine OSA, and detect central sleep apnea (CSA). Primary Objective: To rigorously evaluate the overall performance of the BR with Gen3 DL Algorithms and Subxiphoid Body Sensor in assessing SDB in individuals referred to the sleep labs with clinical suspicion of sleep apnea and a STOP-Bang score \> 3, by comparing to the attended in-lab PSG, the gold standard. Secondary Objectives: To determine the accuracy of BR sleep stage parameters using the Gen3 DL algorithms by comparing to the in-lab PSG; To assess the accuracy of the BR arrhythmia detection algorithm; To assess the impact of CPAP on HRV (both time- and frequency-domain), delta HR, hypoxic burden, and PWADI during split night studies; To assess if any of the baseline HRV parameters (both time- and frequency-domain), delta heart rate (referred to as Delta HR), hypoxic burden, and pulse wave amplitude drop index (PWADI) or the change of these parameters may predict CPAP compliance; To evaluate the minimum duration of quality data necessary for BR to achieve OSA diagnosis; To examine the performance of OSA screening tools using OSA predictive AI models formulated by National Taiwan University Hospital (NTUH) and Northeast Ohio Medical University (NEOMED).

Conditions

Sleep-Disordered Breathing; Sleep Architecture; Arrhythmia

Keywords

Obstructive Sleep Apnea; Wearable; Home Sleep Test; Photoplethysmography; Deep Learning; Predictive AI models

Outcome Measures

Primary Outcomes (1)

• Performance of diagnosing sleep disordered breathing by BR's Gen3 DL algorithms

  To establish mean, standard deviation, and target clinical agreement limit values for the differences in sleep-disordered breathing parameters (including AHI3%, AHI4%, REM AHI 3%, REM AHI4%, Supine AHI3%, Supine AHI4%, and CAI) from the BR against PSG. To calculate the sensitivity and specificity values, along with 95% confidence intervals (CIs), for sleep-disordered breathing parameters from the BR against PSG at PSG cutoffs of 5, 15, and 30 events/h. Pearson correlation and regression analysis will be employed to assess the association between sleep-disordered breathing parameters obtained from the BR and PSG.

  2 years

Secondary Outcomes (5)

• Performance of sleep stage classification by BR's Gen3 DL algorithms

  2 years

• To evaluate the minimum duration of quality data necessary for OSA diagnosis

  2 years

• Accuracy of the BR arrhythmia-detecting algorithm

  3 years

• Biomarker relationship analysis

  3 years

• Accuracy of the NTUH and NEOMED models

  3 years

Study Arms (1)

UH-Participant

EXPERIMENTAL

Potential participants will be identified from patients scheduled for in-lab PSG at the two medical centers of University Hospitals

Device: Belun Ring; Device: Belun Cor

Interventions

Belun Cor DEVICE

The "Belun Cor" body sensor accessory is composed of an accelerometer, a temperature sensor, and a lithium battery. It will be placed immediately below the xiphoid process in the upper abdomen with a medical adhesive to detect the body temperature, body posture, respiratory rate, and respiratory efforts.

UH-Participant

Belun Ring DEVICE

The Belun Ring sensor should be placed on the palmar side of the proximal phalanx of the index finger and the sensor should be placed along the radial artery such that the accuracy of the device will be minimally affected by skin color. The Ring has 7 adjustable arms for different finger sizes. Each device is reusable after thorough cleaning with an alcohol swab.

UH-Participant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed informed consent form.
• Clinically assessed and suspicious for OSA with a STOP-Bang score ≥ 3.

You may not qualify if:

• Full night PAP titration study.
• On home O2, noninvasive ventilator, diaphragmatic pacing, or any form of a nerve stimulator.
• Having atrial fibrillation-flutter, pacemaker/defibrillator, left ventricular assist device (LVAD), or status post cardiac transplantation.
• 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.
• If a participant did not sleep for at least 4 hours of technically valid sleep based on the Belun Ring method for diagnostic assessments, or a minimum of 3 hours of technically valid sleep during the diagnostic phase of a split-night study, the patient will be excluded from statistical analysis.

Sponsors & Collaborators

• Belun Technology Company Limited: lead
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (2)

UH Geauga Health Center Services

Chardon, Ohio, 44024, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Arrhythmias, Cardiac; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ambrose A. Chiang, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Susheel P. Patil, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Kingman P. Strohl, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 13, 2024
• Study Start: July 19, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)