Validation of Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor (NCT06255613) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Validation of Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor
United States79 participantsStarted 2024-07-19
Plain-language 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).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provision of signed informed consent form.
* Clinically assessed and suspicious for OSA with a STOP-Bang score ≥ 3.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Performance of diagnosing sleep disordered breathing by BR's Gen3 DL algorithms