NCT06255613

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

Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor: Exploring Its Diagnostic Capabilities for Sleep Disordered Breathing With Analysis of Biomarker Dynamics

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (estimated)
• Sponsor: Belun Technology Company Limited · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-07-19
• Primary completion: 2026-03-31
• Completion: 2027-09-30
• First posted: 2024-02-13
• Last updated: 2026-03-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study