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NCT04718142 · ClinicalTrials.gov registry record · NA
Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study
A NA study of Obstructive Sleep Apnea, sponsored by Somne.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT04718142 is a NA study of Obstructive Sleep Apnea that has completed, run by Somne. The registered enrollment target is 28 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04718142, a NA study of Obstructive Sleep Apnea, has completed, sponsored by Somne.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary treatment for OSA. Negative external pressure, applied over the anterior neck under the mandible, has shown encouraging results as an alternative therapy. This study assessed a variety of sizes and shapes of collars and a range of pressures for variable negative external pressure (vNEP) treatment in subjects having moderate OSA to identify combinations that improve the efficacy and comfort of this emerging therapy. Observations made in this study may be used to plan a more definitive follow-on investigation.
Conditions Studied
Interventions
- DEVICE vNEP
Study Locations (1)
California
- California Center for Sleep Disorders - San Leandro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-10-19 |
| Est. Completion | 2021-03-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04718142
The ClinicalTrials.gov registry entry for NCT04718142 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (87% lower). The listed sponsor is Somne, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which vNEP is the first listed.
NCT04718142 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04718142 about?
NCT04718142 is a clinical study titled "Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study". Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary treatment for OSA. Negative external pressure, applied over the anterior neck under the mandible, has shown encouraging results as an alternative therapy. This study assessed a variety of sizes and shapes of colla...
What is the current status of trial NCT04718142?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2020-10-19. Estimated completion is 2021-03-30.
What conditions does trial NCT04718142 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT04718142?
The interventions under investigation include: vNEP (DEVICE).
Who is sponsoring clinical trial NCT04718142?
This trial is sponsored by Somne, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04718142 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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