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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Provision of signed informed consent form.

• Clinically assessed and suspicious for OSA with a STOP-Bang score ≥ 3.

Locations
United States
Ohio
UH Geauga Health Center Services
RECRUITING
Chardon
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Contact Information
Primary
Tiffany Tsai
tiffany.tsai2@va.gov
216-844-3201
Time Frame
Start Date: 2024-07-19
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 79
Treatments
Experimental: UH-Participant
Potential participants will be identified from patients scheduled for in-lab PSG at the two medical centers of University Hospitals
Related Therapeutic Areas
Sponsors
Leads: Belun Technology Company Limited
Collaborators: University Hospitals Cleveland Medical Center

This content was sourced from clinicaltrials.gov