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NCT04121923 · ClinicalTrials.gov registry record · NA
Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea
A NA study, sponsored by Belun Technology Company Limited.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
NCT04121923: Completed NA study, sponsored by Belun Technology Company Limited.
NCT04121923 is a NA study that has completed, run by Belun Technology Company Limited. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04121923, a NA study, has completed, sponsored by Belun Technology Company Limited.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
Study 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). 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.
Primary Outcome
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 fro
Interventions
- DEVICE Belun Ring Pulse Oximeter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2019-05-30 |
| Phase | NA |
What the finished NCT04121923 record still lists
NCT04121923 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Belun Ring Pulse Oximeter is the first listed.
NCT04121923 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04121923 about?
NCT04121923 is a clinical study titled "Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea". 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, i...
What is the current status of trial NCT04121923?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2018-03-01. Estimated completion is 2019-05-30.
What interventions are being tested in trial NCT04121923?
The interventions under investigation include: Belun Ring Pulse Oximeter (DEVICE).
Who is sponsoring clinical trial NCT04121923?
This trial is sponsored by Belun Technology Company Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04121923's enrollment target sits among peer trials
70 1103rd of 2000 higher than 868 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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