Sleep Apnea, ObstructiveNCT04121923
Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea
A study testing Belun Ring Pulse Oximeter in people with Sleep Apnea, Obstructive, run by Belun Technology Company Limited at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the sensitivity and specificity of the Belun Ring Pulse Oximetry system for screening of obstructive sleep apnea (OSA) in adults during standard polysomnography sleep study conditions. The primary outcome metric is the Apnea-Hypopnea Index (AHI). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Belun Ring Pulse Oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 30 May 2019
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must have the ability to understand and provide written informed consent.
- Subject is 18 to 90 years of age.
- Subject must be willing and able to comply with study procedures and duration.
- Male or female of any race.
Who cannot join
- Subject requires oxygen therapy or noninvasive ventilation.
- Subject has a current diagnosis of chronic obstructive pulmonary disorder (COPD), neuromuscular disease, periodic limb movement, or narcolepsy.
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
- Subject is on medication known to interfere with heart rate, such as beta blockers, digoxin, or calcium receptor agonists.
- Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported).
- Unwillingness or inability to remove colored nail polish from test digits.
- Other known health condition, which should be considered.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the sensitivity and specificity of the Belun Ring Pulse Oximetry system for screening of obstructive sleep apnea (OSA) in adults during standard polysomnography sleep study conditions. The primary outcome metric is the Apnea-Hypopnea Index (AHI).
The goal, in its entirety, is to evaluate the performance of the Belun Ring Pulse Oximeter during a standard polysomnography sleep study and its ability to compare to the determined Apnea-Hypopnea Index (AHI) of the subjects. It is expected that the Belun Ring Pulse Oximeter will adequately record SpO2, pulse rate, body position and heart rate variability throughout the duration of the study.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Belun Ring Pulse Oximeter
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belun Ring Pulse OximeterDevice
Belun Ring Pulse Oximeter allows measurement and analysis of oximetry, pulse rate, photo-plethysmography (PPG), and accelerometer signals from the proximal phalanx of index finger. Total sleep time (Ring-TST) and respiratory event index (Ring-REI) are estimated
| Study group | Role | What they receive |
|---|---|---|
| Participant | Experimental | All patients scheduled for attended overnight in-lab polysomnography (PSG) 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 with the results of the PSG on the same patient. There will be no separate arm to test a different device. Receives: Device: Belun Ring Pulse Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Ability of the Ring-REI Measured by Belun Ring to Gauge the AHI Measured by PSG
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Mar 2018
- Primary completion15 Apr 2019
- Study completion30 May 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belun Technology Company Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Clinimark, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121923
- Sponsor's protocol ID
- PR 2018-259
- Status last verified
- Apr 2026
- First submitted
- 9 Oct 2019
- Last updated
- 26 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gu W, Leung L, Kwok KC, Wu IC, Folz RJ, Chiang AA. Belun Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea. J Clin Sleep Med. 2020 Sep 15;16(9):1611-1617. doi: 10.5664/jcsm.8592.
PubMed 32464087