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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 is a NA study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 113 participants.

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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.

Interventions

  • DEVICE Belun Ring
  • DIAGNOSTIC_TEST PSG

Trial Details

FieldValue
Enrollment Target 113 participants
Start Date 2019-05-06
Est. Completion 2019-07-30
Phase NA

What the Registry Record Tells You About NCT03997916

The ClinicalTrials.gov registry entry for NCT03997916 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Belun Ring is the first listed.

NCT03997916 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.