- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03997916
Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea
April 19, 2022 updated by: Eric Yeh, MD, University Hospitals Cleveland Medical Center
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
113
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mary Andrews, RRT
- Phone Number: 216-844-2386
- Email: mary.andrews@uhhospitals.org
Study Contact Backup
- Name: Jessica Guggenbiller, MSN, APRN
- Phone Number: 330-388-6598
- Email: jessica.guggenbiller@uhhospitals.org
Study Locations
-
-
Ohio
-
Beachwood, Ohio, United States, 44122
- Residence Inn Marriott
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Same night when both testing were done on the same subject
|
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
|
Same night when both testing were done on the same subject
|
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
|
Same night when both testing were done on the same subject
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Ambrose Chiang, MD, University Hospitals Cleveland Medical Center
- Principal Investigator: Eric Yeh, MD, University Hospitals Cleveland Medical Center
- Study Director: Kingman Strohl, MD, University Hospitals Cleveland Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2019
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
July 30, 2019
Study Registration Dates
First Submitted
June 23, 2019
First Submitted That Met QC Criteria
June 24, 2019
First Posted (Actual)
June 25, 2019
Study Record Updates
Last Update Posted (Estimate)
January 19, 2023
Last Update Submitted That Met QC Criteria
April 19, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY20181042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
ResMedCompletedObstructive Sleep Apnea (OSA)United States, Australia
-
ApnimedCompletedOSA - Obstructive Sleep ApneaUnited States
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
Clinical Trials on Belun Ring
-
Belun Technology Company LimitedStanford UniversityCompletedSleep-Disordered Breathing | Sleep ArchitectureUnited States
-
Stanford UniversityBelun Technology Company LimitedCompleted
-
Belun Technology Company LimitedUniversity Hospitals Cleveland Medical CenterRecruitingSleep-Disordered Breathing | Sleep ArchitectureUnited States
-
Belun Technology Company LimitedClinimark, LLCCompletedSleep Apnea, ObstructiveUnited States
-
Belun Technology Company LimitedUniversity Hospitals Cleveland Medical CenterNot yet recruitingArrhythmia | Sleep-Disordered Breathing | Sleep Architecture
-
Taipei Medical University Shuang Ho HospitalCase Western Reserve UniversityRecruitingStroke, Acute | Sleep-Disordered Breathing | Sleep ArchitectureTaiwan
-
Cairo UniversityNot yet recruiting
-
University of Sao PauloCompletedEye Diseases | Keratoconus | Cornea | Ophthalmological DisorderBrazil
-
Meshalkin Research Institute of Pathology of CirculationCompletedMitral Regurgitation
-
Clinica GastrobeseTerminatedVomiting | Gastroesophageal Reflux Disease | Morbid ObesityBrazil