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Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03997916
Recruitment Status : Completed
First Posted : June 25, 2019
Results First Posted : January 19, 2023
Last Update Posted : January 19, 2023
Sponsor:
Collaborator:
Belun Technology Company Limited
Information provided by (Responsible Party):
Eric Yeh, MD, University Hospitals Cleveland Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Belun Ring Diagnostic Test: PSG Not Applicable

Detailed Description:
This study will include all patients who are scheduled to do an attended overnight in-lab polysomnography in 2 sleep labs owned by University Hospitals Cleveland Medical Center. These patients will receive email recruitment forms 2 weeks prior their scheduled polysomnography. Whether they are interested or not, patients are supposed to call or email the study's central contact person. Both phone number and email address of the central contact person are noted in the email recruitment form. For those patients who did not make any contact with the study's central contact person, they will be screened for eligibility by sub-investigators through chart review. List of eligible patients will be sent to the central contact backup person who is basically in-charge of making phone calls to the patients. This person will further confirm patients' eligibility over the phone and ask if they are interested. If a patient is interested, the central contact backup person will inform the sub-investigators who, in turn, will assign a unique patient identifier to the interested subject and inform the sleep lab contact person. The sleep lab contact person will, in turn, inform the sleep technicians on-call ahead of time about the list of interested subjects. On the night of the polysomnography testing of the interested subject, the latter will receive questionnaires and written informed consent form related to the study which will be explained by the sleep technician. After the subject had completed and signed the questionnaires and written informed consent form respectively, the sleep technician will apply the Belun Ring device on the patient as well as the electrodes and sensors included in a routine polysomnography. The following day, data from Belun Ring device will be uploaded to the laptop while another sleep technician will read the polysomnography. Sub-investigators will enter the data from the questionnaires, Belun Ring device, and polysomnography in the secured University Hospitals Redcap (UHRedcap). Once the target number of subjects are reached, all data will be sent to statistician for analysis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Validation Investigation of the Accuracy of the Belun Ring, an Innovative Single-channel Four-signal Pulse Oximetry, in Patients Referred to Sleep Lab for Assessment of Obstructive Sleep Apnea
Actual Study Start Date : May 6, 2019
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Participant
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
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.

Diagnostic Test: PSG
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.


Outcome Measures
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Primary Outcome Measures :
  1. Performance (Mean With 95% CI) of bAHI at PSG--AHI Cutoffs of 5, 15 and 30 (Accuracy) [ Time Frame: Same night when both testing were done on the same subject ]
    Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea

  2. Sensitivity [ Time Frame: Same night when both testing were done on the same subject ]
    Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea

  3. Specificity [ Time Frame: Same night when both testing were done on the same subject ]
    Comparing the accuracy, sensitivity, specificity of Belun Ring Device versus gold standard Polysomnography for Obstructive Sleep Apnea


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997916


Locations
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United States, Ohio
Residence Inn Marriott
Beachwood, Ohio, United States, 44122
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Belun Technology Company Limited
Investigators
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Principal Investigator: Eric Yeh, MD University Hospitals Cleveland Medical Center
Study Director: Ambrose Chiang, MD University Hospitals Cleveland Medical Center
Study Director: Kingman Strohl, MD University Hospitals Cleveland Medical Center
  Study Documents (Full-Text)

Documents provided by Eric Yeh, MD, University Hospitals Cleveland Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] July 16, 2019
Informed Consent Form  [PDF] July 16, 2019

More Information
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Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eric Yeh, MD, Fellow in Sleep Medicine, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03997916    
Other Study ID Numbers: STUDY20181042
First Posted: June 25, 2019    Key Record Dates
Results First Posted: January 19, 2023
Last Update Posted: January 19, 2023
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Eric Yeh, MD, University Hospitals Cleveland Medical Center:
Belun Ring
pulse oximeter
obstructive sleep apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases