Assessment of a new wearable device for sleep apnea
Belun Ring Platform (BLS-100) Home Sleep Apnea Testing Device With an Improved Algorithm for Assessment of Obstructive Sleep Apnea: A Comparison to In-Lab Polysomnography
This study is testing a new wearable device called the Belun Ring to see if it can accurately diagnose sleep apnea in adults aged 18-80 compared to standard sleep tests.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Belun Technology Company Limited Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04885062 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the Belun Ring, a novel home sleep apnea testing device that uses a pulse oximeter sensor and an advanced analytic algorithm to assess obstructive sleep apnea (OSA). Participants aged 18-80 who are clinically suspected of having OSA will be monitored using this device to determine its effectiveness compared to traditional polysomnography. The study aims to validate the accuracy and reliability of the Belun Ring in diagnosing sleep-disordered breathing. By utilizing a wearable technology, the trial seeks to provide a more accessible and convenient method for OSA assessment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 who have been clinically assessed and are suspected of having obstructive sleep apnea.
Not a fit: Patients with certain cardiac conditions, those on specific treatments like narcotics, or those who have recently undergone surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more convenient and effective way for patients to be diagnosed with obstructive sleep apnea.
How similar studies have performed: Other studies have shown promise in using wearable technology for sleep apnea assessment, but the specific approach of the Belun Ring is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form. * Age 18-80 * Clinically assessed and suspicious for OSA Exclusion Criteria: * Full night PAP titration study * On home O2, noninvasive ventilator, diaphragmatic pacing, or any form of nerve stimulator * Having atrial fibrillation-flutter, pacemaker/defibrillator, LVEF \< 55%, left ventricular assist device (LVAD), or status post cardiac transplantation * Patients taking narcotics * 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 An individual who meets the above criteria but fails to have at least 4 hours of technically valid sleep based on BLS-100 in a diagnostic study or at least 3 hours of technically valid sleep during the diagnostic portion of a split night study will be excluded from statistical analyses.
Where this trial is running
Cleveland, Ohio
- 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: Ambrose A Chiang, MD
- Email: Ambrose.Chiang@UHhospitals.org
- Phone: 216-791-3800
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.