Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea

NCT03997916 | Completed Results FDA Device

• 1 other identifier: STUDY20181042
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

Belun Ring; pulse oximeter; obstructive sleep apnea

Outcome Measures

Primary Outcomes (3)

• Performance (Mean With 95% CI) of bAHI at PSG--AHI Cutoffs of 5, 15 and 30 (Accuracy)

  Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea

  Same night when both testing were done on the same subject

• Sensitivity

  Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea

  Same night when both testing were done on the same subject

• Specificity

  Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea

  Same night when both testing were done on the same subject

Study Arms (1)

Participant

OTHER

All patients scheduled for attended overnight in-lab polysomnography (PSG), also known as sleep study, in our 2 sleep labs will undergo PSG testing. On the same night of the PSG testing, these same patients will also wear the Belun Ring device. After the study, we will compare results of the Belun Ring device vis-à-vis with the results of the PSG on the same patient. There will be no separate arm to test a different device.

Device: Belun Ring; Diagnostic Test: PSG

Interventions

Belun Ring DEVICE

All patients scheduled for attended overnight in-lab polysomnography (PSG) in our 2 sleep labs will undergo PSG testing. On the same night of the PSG testing, these same patients will also wear the Belun Ring device. After the study, we will compare results of the Belun Ring device vis-à-vis with the results of the PSG on the same patient.

Participant

PSG DIAGNOSTIC_TEST

All patients scheduled for attended overnight in-lab polysomnography (PSG) in our 2 sleep labs will undergo PSG testing. On the same night of the PSG testing, these same patients will also wear the Belun Ring device. After the study, we will compare results of the Belun Ring device vis-à-vis with the results of the PSG on the same patient.

Participant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Belun Technology Company Limited: collaborator

Study Sites (2)

Residence Inn Marriott

Beachwood, Ohio, 44122, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Yeh E, Wong E, Tsai CW, Gu W, Chen PL, Leung L, Wu IC, Strohl KP, Folz RJ, Yar W, Chiang AA. Detection of obstructive sleep apnea using Belun Sleep Platform wearable with neural network-based algorithm and its combined use with STOP-Bang questionnaire. PLoS One. 2021 Oct 11;16(10):e0258040. doi: 10.1371/journal.pone.0258040. eCollection 2021.

  PMID: 34634070 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Eric Yeh, MD
• Organization: University Hospitals Cleveland Medical Center

eric.yeh@uhhospitals.org

216-844-1867

Study Officials

• Eric Yeh, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Ambrose Chiang, MD

  University Hospitals Cleveland Medical Center

  STUDY DIRECTOR

• Kingman Strohl, MD

  University Hospitals Cleveland Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Sleep Medicine

Study Record Dates

• First Submitted: June 23, 2019
• First Posted: June 25, 2019
• Study Start: May 6, 2019
• Primary Completion: June 30, 2019
• Study Completion: July 30, 2019
• Last Updated: January 19, 2023
• Results First Posted: January 19, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)