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Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03997916
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
Belun Technology Company Limited
Information provided by (Responsible Party):
Eileen Wong, MD, University Hospitals Cleveland Medical Center

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.




Primary Outcome Measures :
  1. accuracy, sensitivity, and specificity of the Belun Ring device [ Time Frame: The duration when patient is undergoing the overnight in-lab polysomnography with the Belun Ring devic is about 6-8 hours. Once the target number of subjects are received, we will forward data to statistician. We estimate this duration to be 6-8 weeks. ]
    Sensitivity (the proportion of patients correctly diagnosed with obstructive sleep apnea) and specificity (the proportion of patients correctly rejected as having obstructive sleep apnea) values of sleep scores will be computed. The area under the receiving operating characteristic (ROC) curve will also be calculated. A sensitivity value of .825 will be considered clinically significant. Pearson correlation will be used to identify the association between obstructive sleep apnea and polysomnography apnea-hypopnea index (PSG AHI) diagnoses. Bland and Altman plots will be generated to demonstrate the degree of identity between the outcomes of the Belun Rung and PSG AHI diagnostic methods.



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Mary Andrews, RRT 216-844-2386 mary.andrews@uhhospitals.org
Contact: Jessica Guggenbiller, MSN, APRN 330-388-6598 jessica.guggenbiller@uhhospitals.org

Locations
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United States, Ohio
Residence Inn Marriott Recruiting
Beachwood, Ohio, United States, 44122
Contact: Hilaria Wilson    216-310-5739    hilaria.wilson@uhhospitals.org   
Sub-Investigator: Eric Yeh, MD         
Sub-Investigator: Wail Yar, MD         
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Hilaria Wilson    216-310-5739    hilaria.wilson@uhhospitals.org   
Sub-Investigator: Eric Yeh, MD         
Sub-Investigator: Wail Yar, MD         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Belun Technology Company Limited
Investigators
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Principal Investigator: Eileen Wong, MD University Hospitals Cleveland Medical Center
Study Director: Ambrose Chiang, MD University Hospitals Cleveland Medical Center

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

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Responsible Party: Eileen Wong, MD, Fellow in Sleep Medicine, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03997916     History of Changes
Other Study ID Numbers: STUDY20181042
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Eileen Wong, 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
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases