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NCT06221124 · ClinicalTrials.gov registry record · NA
Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study
A NA study, sponsored by Belun Technology Company Limited.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT06221124: Completed NA study, sponsored by Belun Technology Company Limited.
NCT06221124 is a NA study that has completed, run by Belun Technology Company Limited. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06221124, a NA study, has completed, sponsored by Belun Technology Company Limited.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
Recently, various electronic lifestyle activity monitoring devices (ELAM) are increasingly commercially available. However, the quality and reliability of the data from ELAM are unclear, compared with polysomnography (PSG), which is the gold-standard sleep assessment method. Thus, combining ELAM with PSG will validate ELAM and improve its clinical and research utilization. The investigators propose to conduct this study to validate ELAM device for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab PSG measures of Sleep-Disordered Breathing (SDB) and sleep architecture in adults with obstructive sleep apnea (OSA) symptoms. The investigators propose to recruit a total of 40 participants with symptoms of OSA. The overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep architecture will be validated by using PSG analysis as a gold standard.
Primary Outcome
Concordance rate of bAHI from Belun Ring and apnea-hypopnea Index (AHI) from PSG
Interventions
- DEVICE Belun Ring Pulse Oximeter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-07-15 |
| Est. Completion | 2023-06-12 |
| Phase | NA |
What the finished NCT06221124 record still lists
NCT06221124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Belun Ring Pulse Oximeter is the first listed.
NCT06221124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06221124 about?
NCT06221124 is a clinical study titled "Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study". Recently, various electronic lifestyle activity monitoring devices (ELAM) are increasingly commercially available. However, the quality and reliability of the data from ELAM are unclear, compared with polysomnography (PSG), which is the gold-standard sleep assessment method. Thus, combining ELAM wit...
What is the current status of trial NCT06221124?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2020-07-15. Estimated completion is 2023-06-12.
What interventions are being tested in trial NCT06221124?
The interventions under investigation include: Belun Ring Pulse Oximeter (DEVICE).
Who is sponsoring clinical trial NCT06221124?
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 NCT06221124's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 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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