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Could a ring replace the sleep lab? new study tests home apnea detection

NCT ID NCT04885062

Diagnosis Sponsor: Belun Technology Company Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a ring-shaped device worn on the finger can accurately diagnose obstructive sleep apnea compared to the standard overnight sleep lab test. 136 adults suspected of having sleep apnea wore the Belun Ring while also undergoing standard lab testing. The goal was to see if the ring's measurements of breathing pauses during sleep matched the lab results closely enough to be used at home.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Belun Ring (ring-shaped pulse oximeter with analytic algorithm)
What this could lead to
If accurate, this ring could offer a simpler, more comfortable way to diagnose sleep apnea at home instead of in a sleep lab.
What could go wrong
This is a small, completed study comparing the ring to lab tests. The ring may not be as accurate in real-world home use or in people with other health conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

136 people

The number who actually took part.

Started

Feb 2021

Finished

Jun 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Provision of signed and dated informed consent form. * Age 18-80 * Clinically assessed and suspicious for OSA Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sleep architecture Sleep disordered breathing

Contacts and locations

Locations

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.