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Study Using Negative Pressure to Reduce Apnea
NCT04861038 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04861038
The ClinicalTrials.gov registry entry for NCT04861038 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sommetrics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04861038 reports 15 study locations spanning 10 distinct geographic areas — top geographies include Ohio, California, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04861038?
The interventions under investigation include: aerSleep II (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04861038?
This trial is sponsored by Sommetrics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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