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

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

Interventions

DEVICE

Belun Ring

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.

DEVICE

Belun Cor

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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center

  collaborator OTHER

• Belun Technology Company Limited

  lead OTHER

Principal Investigators

• Ambrose A. Chiang, MD · University Hospitals Cleveland Medical Center

• Susheel P. Patil, MD · University Hospitals Cleveland Medical Center

• Kingman P. Strohl, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-19

Primary Completion

2026-03-31

Completion

2027-09-30

FDA Device

Yes

Countries

• United States

Study Locations