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Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
NCT04950894 · View on ClinicalTrials.gov ↗
Study Summary
Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.
Conditions Studied
Interventions
- DEVICE Hypoglossal Nerve Stimulation
Study Locations (20)
Arizona
- Banner Health — Phoenix
- University of Arizona — Tucson
California
- Sacramento Ent — Roseville
- Paul Schalch Lepe, Md/Silenso Clinic — San Diego
Florida
- Sleep Medicine Specialists of South Florida — Miami
- Morton Plant Mease Health Care — Safety Harbor
Pennsylvania
- Penn State Health — Hershey
- Philadelphia Ear, Nose and Throat Associates — Philadelphia
South Carolina
- Medical University of South Carolina — Charleston
- Bogan Sleep Consultants, Llc — Columbia
Texas
- Houston Methodist — Houston
- Epic Medical Research — Red Oak
Alabama
- University of Alabama At Birmingham — Birmingham
Georgia
- Advanced Ent Associates — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-07-27 |
| Est. Completion | 2025-10-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04950894
The ClinicalTrials.gov registry entry for NCT04950894 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 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LivaNova, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention — of which Hypoglossal Nerve Stimulation 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: NCT04950894 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Arizona, California, Florida. 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 NCT04950894 about?
NCT04950894 is a clinical study titled "Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation". Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.
What is the current status of trial NCT04950894?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2021-07-27. Estimated completion is 2025-10-30.
What conditions does trial NCT04950894 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, OSA, Apnea, Obstructive Sleep, Apnea, Hypopnea, 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 NCT04950894?
The interventions under investigation include: Hypoglossal Nerve Stimulation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04950894?
This trial is sponsored by LivaNova, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04950894 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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