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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Other trials in United States

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

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 groups in NCT04885062
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.

1 Feb 202130 Jun 2022

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04885062
Acronym / sponsor ID: STUDY20201259
Conditions: Sleep-Disordered Breathing, Sleep Architecture
Keywords: Obstructive Sleep Apnea, Wearable, Home Sleep Apnea Testing, Photoplethysmography, Validation, Artificial Intelligence
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: Belun Technology Company LimitedUniversity, hospital or other
Collaborators: University Hospitals Cleveland Medical Center
Study start: 1 Feb 2021 (actual)
Primary completion: 30 Jun 2021 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 13 May 2021 (actual)
Results: Posted 13 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
UH-Participant	Experimental	Device: Belun Ring, Diagnostic Test: PSGPotential 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Provision of signed and dated informed consent form.
Age 18-80
Clinically assessed and suspicious for OSA

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Belun RingThe 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.	Device	UH-Participant
PSGAll 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	UH-Participant

Primary outcome

To Evaluate the Ability of the Belun Ring Pulse Oximeter to Gauge the Apnea-Hypopnea Index (AHI)
Time frame: 1 overnight sleep study (1 Day)
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.

1 secondary outcome

Sleep Stage Parameters
Time frame: 1 overnight sleep study (1 Day)

Results and safety

Results posted to the registry on 13 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
UH-Participant	136	136

Primary outcome: To Evaluate the Ability of the Belun Ring Pulse Oximeter to Gauge the Apnea-Hypopnea Index (AHI)

Time frame: 1 overnight sleep study (1 Day). Mean (Standard Deviation). Unit: events per hour

Measure	UH-Participant n = 84
Value	-1.0 (9.0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From device placement prior to the overnight sleep study until completion of the study monitoring period (approximately 8-10 hours). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
UH-Participant	0 of 136 (0%)	0 of 136 (0%)	0 of 136

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ambrose A Chiang, MD principal investigator

University Hospitals Cleveland Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Evaluate the Ability of the Belun Ring Pulse Oximeter to Gauge the Apnea-Hypopnea Index (AHI) (time frame: 1 overnight sleep study (1 Day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04885062.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.