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NCT04861038 · ClinicalTrials.gov registry record · NA
Study Using Negative Pressure to Reduce Apnea
A NA study of Sleep Apnea, Obstructive and Apnea, Sleep, sponsored by Sommetrics.
- Active
- Registry status
- NA
- Development phase
- 900
- Enrollment target
- 15
- Study locations
NCT04861038: Active NA study of Sleep Apnea, Obstructive and Apnea, Sleep, sponsored by Sommetrics.
NCT04861038 is a NA study of Sleep Apnea, Obstructive and Apnea, Sleep that is active but no longer recruiting, run by Sommetrics. The registered enrollment target is 900 participants, above the 242-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (272% higher). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04861038, a NA study of Sleep Apnea, Obstructive and Apnea, Sleep, is active but no longer recruiting, sponsored by Sommetrics.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 900 participants
- Enrollment target
- 15
- Study locations
Study Summary
The objective of this study is to determine the safety and effectiveness of the aerSleep® II device for treatment of moderate to severe Obstructive Sleep Apnea (OSA) over 24 weeks of home use in spontaneously breathing adult subjects who are intolerant of Continuous Positive Airway Pressure (CPAP) therapy.
Conditions Studied
Interventions
- DEVICE aerSleep II
Study Locations (15)
Ohio
- The MetroHealth System - Cleveland
- Cleveland Clinic Foundation - Cleveland
- The Ohio State University - Columbus
California
- Infinitive Bioresearch - Los Angeles
- BetterNight - San Diego
Pennsylvania
- Thomas Jefferson University - Philadelphia
- UPMC - Pittsburgh
South Carolina
- Bogan Sleep Consultants - Columbia
- BioSerenity - Columbia
Arizona
- University of Arizona - Tucson
Arkansas
- Preferred Research Partners - Little Rock
Colorado
- Delta Waves - Colorado Springs
Florida
- Baptist Hospital - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2021-11-29 |
| Est. Completion | 2025-12 |
| Phase | NA |
What the registry record for NCT04861038 still lists
NCT04861038 is an interventional study that assigns participants to a tested intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, above the 242-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (272% higher).
The record links to 2 conditions, with Sleep Apnea, Obstructive appearing as the primary indexed condition, and to 1 intervention - of which aerSleep II is the first listed.
NCT04861038 lists 15 locations in 10 states (Ohio, California, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT04861038 about?
NCT04861038 is a clinical study titled "Study Using Negative Pressure to Reduce Apnea". The objective of this study is to determine the safety and effectiveness of the aerSleep® II device for treatment of moderate to severe Obstructive Sleep Apnea (OSA) over 24 weeks of home use in spontaneously breathing adult subjects who are intolerant of Continuous Positive Airway Pressure (CPAP) t...
What is the current status of trial NCT04861038?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 900 participants. The study started on 2021-11-29. Estimated completion is 2025-12.
What conditions does trial NCT04861038 study?
This clinical trial studies the following conditions: Sleep Apnea, Obstructive, Apnea, Sleep.
What interventions are being tested in trial NCT04861038?
The interventions under investigation include: aerSleep II (DEVICE).
Who is sponsoring clinical trial NCT04861038?
This trial is sponsored by Sommetrics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04861038 being conducted?
This trial has 15 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sleep Apnea, Obstructive
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 NCT04861038's enrollment target sits among peer trials
900 3rd of 45 higher than 43 of 45 other Sleep Apnea, Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Apnea, Obstructive 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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