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NCT04885062 · ClinicalTrials.gov registry record · NA
Belun Ring Platform With an Improved Algorithm for OSA Assessment
A NA study of Sleep Disordered Breathing and Sleep Architecture, sponsored by Belun Technology Company Limited.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04885062: Recruiting NA study of Sleep Disordered Breathing and Sleep Architecture, sponsored by Belun Technology Company Limited.
NCT04885062 is a NA study of Sleep Disordered Breathing and Sleep Architecture that is actively recruiting participants, run by Belun Technology Company Limited. The registered enrollment target is 100 participants, below the 193-participant average among 19 other Sleep Disordered Breathing trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04885062, a NA study of Sleep Disordered Breathing and Sleep Architecture, is actively recruiting participants, sponsored by Belun Technology Company Limited.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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 analytic algorithm. This study investigates the hypothesis that the BLS-100 is a reasonable HSAT device for OSA assessment.
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
Conditions Studied
Interventions
- DEVICE Belun Ring
- DIAGNOSTIC_TEST PSG
Study Locations (1)
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2022-06-30 |
| Phase | NA |
What NCT04885062 shows while recruiting
NCT04885062 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 193-participant average among 19 other Sleep Disordered Breathing trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with Sleep Disordered Breathing appearing as the primary indexed condition, and to 2 interventions - of which Belun Ring is the first listed.
NCT04885062 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04885062 about?
NCT04885062 is a clinical study titled "Belun Ring Platform With an Improved Algorithm for OSA Assessment". 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...
What is the current status of trial NCT04885062?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-02-01. Estimated completion is 2022-06-30.
What conditions does trial NCT04885062 study?
This clinical trial studies the following conditions: Sleep Disordered Breathing, Sleep Architecture.
What interventions are being tested in trial NCT04885062?
The interventions under investigation include: Belun Ring (DEVICE), PSG (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04885062?
This trial is sponsored by Belun Technology Company Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04885062 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04885062's enrollment target sits among peer trials
100 9th of 19 higher than 11 of 19 other Sleep Disordered Breathing trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Disordered Breathing 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.
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