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N/A Completed N=113 Device Feasibility

Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea

Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT03997916 ↗
Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Performance (Mean With 95% CI) of bAHI at PSG--AHI Cutoffs of 5, 15 and 30 (Accuracy) — 0.564; 0.808; 0.910 proportion of events

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Performance (Mean With 95% CI) of bAHI at PSG--AHI Cutoffs of 5, 15 and 30 (Accuracy)		 0.564; 0.808; 0.910 —
PRIMARY
Sensitivity		 1.000; 0.931; 0.714 —
PRIMARY
Specificity		 0.029; 0.735; 0.953 —

Eligibility Criteria

Inclusion Criteria

  • All adult patients age 18-80 years old scheduled for overnight in-lab sleep study
  • Provision of signed and dated written informed consent form

Exclusion Criteria

  • Recent hospitalization in the past 30 days
  • Patients on home oxygen, non-invasive ventilator, diaphragmatic pacing, or any form of nerve stimulator
  • Patients with pacemaker, defibrillator, left ventricular assist device (LVAD), or status post cardiac transplantation
  • Patients with baseline heart rate under 50 bpm or over 100 bpm during last clinic visit or prior to study at the sleep lab
  • Patients with unstable cardiopulmonary status judged to be unsafe for sleep study by the sleep technician and/or the on-call sleep physician in the sleep lab on the night of the study
  • Patients who are unable to complete the required study
  • Patients involved in another investigational study
  • Pregnant women
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03997916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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