Evaluating a wearable device for diagnosing sleep apnea
Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor: Exploring Its Diagnostic Capabilities for Sleep Disordered Breathing With Analysis of Biomarker Dynamics
This study is testing a new wearable device to see if it can accurately diagnose sleep apnea in people who might have it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 79 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Belun Technology Company Limited Academic / other |
| Locations | 2 sites (Chardon, Ohio and 1 other locations) |
| Trial ID | NCT06255613 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the Belun Ring Gen3 deep learning algorithms in conjunction with a subxiphoid body sensor for diagnosing sleep-disordered breathing, particularly obstructive sleep apnea (OSA). Participants with a clinical suspicion of OSA will undergo assessments using the Belun Ring, and results will be compared to the gold standard of in-lab polysomnography (PSG). The study will also evaluate the device's ability to detect sleep stages and arrhythmias, as well as the impact of CPAP therapy on heart rate variability and other metrics during split-night studies.
Who should consider this trial
Good fit: Ideal candidates are individuals with a STOP-Bang score greater than 3 who are clinically suspected of having obstructive sleep apnea.
Not a fit: Patients with unstable cardiopulmonary status or those who have had recent surgeries or hospitalizations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and accurate method for diagnosing sleep apnea, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using wearable technology for sleep apnea diagnosis, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chardon, Ohio and 1 other locations
- UH Geauga Health Center Services — Chardon, Ohio, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ambrose A. Chiang, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Tiffany Tsai
- Email: tiffany.tsai2@va.gov
- Phone: 216-844-3201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.