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NCT06255613 · ClinicalTrials.gov registry record · NA
Validation of Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor
A NA study of Sleep Disordered Breathing and Arrhythmia, sponsored by Belun Technology Company Limited.
- Active
- Registry status
- NA
- Development phase
- 79
- Enrollment target
- 2
- Study locations
NCT06255613: Active NA study of Sleep Disordered Breathing and Arrhythmia, sponsored by Belun Technology Company Limited.
NCT06255613 is a NA study of Sleep Disordered Breathing and Arrhythmia that is active but no longer recruiting, run by Belun Technology Company Limited. The registered enrollment target is 79 participants, below the 194-participant average among 19 other Sleep Disordered Breathing trials with a reported enrollment target (59% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06255613, a NA study of Sleep Disordered Breathing and Arrhythmia, is active but no longer recruiting, sponsored by Belun Technology Company Limited.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 79 participants
- Enrollment target
- 2
- Study locations
Study Summary
Hypothesis: BR's Gen3 DL algorithms, combined with its subxiphoid body sensor, can accurately diagnose OSA, categorize its severity, identify REM OSA and supine OSA, and detect central sleep apnea (CSA). Primary Objective: To rigorously evaluate the overall performance of the BR with Gen3 DL Algorithms and Subxiphoid Body Sensor in assessing SDB in individuals referred to the sleep labs with clinical suspicion of sleep apnea and a STOP-Bang score \> 3, by comparing to the attended in-lab PSG, the gold standard. Secondary Objectives: To determine the accuracy of BR sleep stage parameters using the Gen3 DL algorithms by comparing to the in-lab PSG; To assess the accuracy of the BR arrhythmia detection algorithm; To assess the impact of CPAP on HRV (both time- and frequency-domain), delta HR, hypoxic burden, and PWADI during split night studies; To assess if any of the baseline HRV parameters (both time- and frequency-domain), delta heart rate (referred to as Delta HR), hypoxic burden, and pulse wave amplitude drop index (PWADI) or the change of these parameters may predict CPAP compliance; To evaluate the minimum duration of quality data necessary for BR to achieve OSA diagnosis; To examine the performance of OSA screening tools using OSA predictive AI models formulated by National Taiwan University Hospital (NTUH) and Northeast Ohio Medical University (NEOMED).
Primary Outcome
To establish mean, standard deviation, and target clinical agreement limit values for the differences in sleep-disordered breathing parameters (including AHI3%, AHI4%, REM AHI 3%, REM AHI4%, Supine AHI3%, Supine AHI4%, and CAI) from the BR against PSG. To calculate the sensitivity and specificity values, along with 95% confidence intervals (CIs), for sleep-disordered breathing parameters from the BR against PSG at PSG cutoffs of 5, 15, and 30 events/h. Pearson correlation and regression analysis
Conditions Studied
Interventions
- DEVICE Belun Ring
- DEVICE Belun Cor
Study Locations (2)
Ohio
- UH Geauga Health Center Services - Chardon
- University Hospitals Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2024-07-19 |
| Est. Completion | 2027-09-30 |
| Phase | NA |
What the registry record for NCT06255613 still lists
NCT06255613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 194-participant average among 19 other Sleep Disordered Breathing trials with a reported enrollment target (59% lower).
The record links to 3 conditions, with Sleep Disordered Breathing appearing as the primary indexed condition, and to 2 interventions - of which Belun Ring is the first listed.
NCT06255613 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06255613 about?
NCT06255613 is a clinical study titled "Validation of Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor". Hypothesis: BR's Gen3 DL algorithms, combined with its subxiphoid body sensor, can accurately diagnose OSA, categorize its severity, identify REM OSA and supine OSA, and detect central sleep apnea (CSA). Primary Objective: To rigorously evaluate the overall performance of the BR with Gen3 DL Algor...
What is the current status of trial NCT06255613?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 79 participants. The study started on 2024-07-19. Estimated completion is 2027-09-30.
What conditions does trial NCT06255613 study?
This clinical trial studies the following conditions: Sleep Disordered Breathing, Arrhythmia, Sleep Architecture.
What interventions are being tested in trial NCT06255613?
The interventions under investigation include: Belun Ring (DEVICE), Belun Cor (DEVICE).
Who is sponsoring clinical trial NCT06255613?
This trial is sponsored by Belun Technology Company Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06255613 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06255613's enrollment target sits among peer trials
79 11th of 19 higher than 9 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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