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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 is a NA study that has completed, run by Belun Technology Company Limited. The registered enrollment target is 70 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04121923
The ClinicalTrials.gov registry entry for NCT04121923 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Belun Technology Company Limited, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Belun Ring Pulse Oximeter is the first listed.
NCT04121923 reports 0 study locations.
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.
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