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NCT03997916 · ClinicalTrials.gov registry record · NA
Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea
A NA study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 113
- Enrollment target
NCT03997916: Completed NA study, sponsored by University Hospitals Cleveland Medical Center.
NCT03997916 is a NA study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 113 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03997916, a NA study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 113 participants
- Enrollment target
Study Summary
This study aims to determine the overall accuracy, sensitivity, and specificity of the Belun Ring device in evaluating obstructive sleep apnea by comparing the device to the attended overnight in-lab polysomnography which is the gold standard for diagnosis of obstructive sleep apnea. Our hypothesis is that the Belun-Ring, a type 4 portable monitoring device, is overall sensitive and specific for evaluation of obstructive sleep apnea when compared to the attended overnight in-lab polysomnography.
Primary Outcome
Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea
Interventions
- DEVICE Belun Ring
- DIAGNOSTIC_TEST PSG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2019-05-06 |
| Est. Completion | 2019-07-30 |
| Phase | NA |
What the finished NCT03997916 record still lists
NCT03997916 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Belun Ring is the first listed.
NCT03997916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03997916 about?
NCT03997916 is a clinical study titled "Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea". This study aims to determine the overall accuracy, sensitivity, and specificity of the Belun Ring device in evaluating obstructive sleep apnea by comparing the device to the attended overnight in-lab polysomnography which is the gold standard for diagnosis of obstructive sleep apnea. Our hypothesis ...
What is the current status of trial NCT03997916?
This trial is currently completed. It is a NA study. The enrollment target is 113 participants. The study started on 2019-05-06. Estimated completion is 2019-07-30.
What interventions are being tested in trial NCT03997916?
The interventions under investigation include: Belun Ring (DEVICE), PSG (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03997916?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03997916's enrollment target sits among peer trials
113 813th of 2000 higher than 1,188 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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