Sleep-Disordered BreathingNCT04885062
Belun Ring Platform With an Improved Algorithm for OSA Assessment
A study testing Belun Ring and PSG in people with Sleep-Disordered Breathing and Sleep Architecture, run by Belun Technology Company Limited at 1 site in United States.
Trial summary
OSA is commonly diagnosed with either attended in-lab polysomnography (PSG) or unattended home sleep apnea testing (HSAT). The BLS-100 (Belun Technology Company Limited, Hong Kong) is a novel neural network-based HSAT platform consists of a ring shape pulse oximeter sensor, a cradle, and an improved proprietary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep-Disordered Breathing, Sleep Architecture
- What is being tested?
- Belun Ring and PSG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 30 Jun 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Age 18-80
- Clinically assessed and suspicious for OSA
Who cannot join
- Full night PAP titration study
- On home O2, noninvasive ventilator, diaphragmatic pacing, or any form of nerve stimulator
- Having atrial fibrillation-flutter, pacemaker/defibrillator, LVEF < 55%, left ventricular assist device (LVAD), or status post cardiac transplantation
- Patients taking narcotics
- Recent hospitalization or recent surgery in the past 30 days
- Unstable cardiopulmonary status on the night of the study judged to be unsafe for sleep study by the sleep tech and/or the on-call sleep physician
- An individual who meets the above criteria but fails to have at least 4 hours of technically valid sleep based on BLS-100 in a diagnostic study or at least 3 hours of technically valid sleep during the diagnostic portion of a split night study will be excluded from statistical analyses.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Belun Ring Platform (BLS-100) Home Sleep Apnea Testing Device With an Improved Algorithm for Assessment of Obstructive Sleep Apnea: A Comparison to In-Lab Polysomnography
OSA is commonly diagnosed with either attended in-lab polysomnography (PSG) or unattended home sleep apnea testing (HSAT). The BLS-100 (Belun Technology Company Limited, Hong Kong) is a novel neural network-based HSAT platform consists of a ring shape pulse oximeter sensor, a cradle, and an improved proprietary analytic algorithm. This study investigates the hypothesis that the BLS-100 is a reasonable HSAT device for OSA assessment.
- Conditions
- Sleep-Disordered Breathing, Sleep Architecture
- Being tested
- Belun Ring, PSG
- Keywords
- Obstructive Sleep Apnea, Wearable, Home Sleep Apnea Testing, Photoplethysmography, Validation, Artificial Intelligence
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belun RingDevice
The Belun Ring sensor will be applied to the proximal phalanx of the index finger in the non-dominant hand of the participating individuals prior to their sleep onset in the sleep lab and will be removed upon awakening at the end of the sleep period on the following morning. The attended in-lab sleep study will be performed simultaneously in a standard fashion.
PSGDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| UH-Participant | Experimental | Potential participants with suspected OSA will be identified from the schedule of the UH Beachwood and Bolwell sleep labs.Those subjects who satisfy the study inclusion and exclusion criteria will be approached and invited to participate in the study. Receives: Device: Belun Ring; Diagnostic Test: PSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Ability of the Belun Ring Pulse Oximeter to Gauge the Apnea-Hypopnea Index (AHI)
Apnea-Hypopnea Index (AHI) is defined as the total number of apnea and hypopnea events per hour of sleep, where higher values indicate more severe sleep-disordered breathing. In this study, standard overnight polysomnography(PSG) and Belun Ring pulse oximeter were simultaneously measured. The AHI derived from PSG data was served as the reference.
The primary outcome evaluates the accuracy of the Belun Ring by calculating the difference in Ring-REI by the Belun Ring compared with AHI derived from PSG recordings for each participant. The difference was calculated as:
Ring-REI (Belun Ring) - AHI (PSG).
Negative values indicate that the Belun Ring estimated a lower AHI than PSG, while positive values indicate that the Belun Ring estimated a higher AHI than PSG.
Summary statistics of these differences were used to assess agreement between the Belun Ring device and PSG in measuring sleep apnea severity.
Measured: 1 overnight sleep study (1 Day)
Secondary outcomes (1)
Sleep Stage Parameters
To determine the accuracy of BLS-100 sleep stage parameters to classify the human sleep stage (Wake, REM and Non-REM) by comparing to the classification results of in-lab PSG.
Measured: 1 overnight sleep study (1 Day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Feb 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep-Disordered BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belun Technology Company Limited
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Responsible party
- Sponsor
- Investigators
- Ambrose A Chiang, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885062
- Sponsor's protocol ID
- STUDY20201259
- Status last verified
- Mar 2026
- First submitted
- 4 May 2021
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No