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Deep Learning Algorithms
Belun Ring for Sleep Apnea
N/A
Recruiting
Led By Ambrose A. Chiang, MD
Research Sponsored by Belun Technology Company Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Recent hospitalization or recent surgery in the past 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if the BR device, along with its advanced algorithms and body sensor, can accurately diagnose and categorize different types of sleep apnea. The main goal is to compare its performance
Who is the study for?
This trial is for individuals suspected of having sleep apnea, indicated by a clinical assessment and a STOP-Bang score of 3 or higher. Participants must provide informed consent to join the study.
What is being tested?
The Belun Ring with Gen3 Deep Learning Algorithms and Subxiphoid Body Sensor is being tested against in-lab polysomnography (PSG) to diagnose sleep apnea, determine its severity, identify specific types of sleep apnea, and detect arrhythmias.
What are the potential side effects?
Since this trial involves non-invasive monitoring devices like the Belun Ring and body sensor rather than medication, side effects are minimal but may include discomfort from wearing the device.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not been hospitalized or had surgery in the last 30 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Performance of diagnosing sleep disordered breathing by BR's Gen3 DL algorithms
Secondary study objectives
Accuracy of the BR arrhythmia-detecting algorithm
Accuracy of the NTUH and NEOMED models
Biomarker relationship analysis
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: UH-ParticipantExperimental Treatment2 Interventions
Potential participants will be identified from patients scheduled for in-lab PSG at the two medical centers of University Hospitals
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belun Ring
2019
N/A
~160
Find a Location
Who is running the clinical trial?
Belun Technology Company LimitedLead Sponsor
7 Previous Clinical Trials
364 Total Patients Enrolled
University Hospitals Cleveland Medical CenterOTHER
330 Previous Clinical Trials
391,607 Total Patients Enrolled
Ambrose A. Chiang, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
Kingman P. Strohl, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
1 Previous Clinical Trials
8 Total Patients Enrolled
Susheel P. Patil, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center