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NCT04950894 · ClinicalTrials.gov registry record · NA
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
A NA study of Obstructive Sleep Apnea and OSA, sponsored by LivaNova.
- Active
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT04950894: Active NA study of Obstructive Sleep Apnea and OSA, sponsored by LivaNova.
NCT04950894 is a NA study of Obstructive Sleep Apnea and OSA that is active but no longer recruiting, run by LivaNova. The registered enrollment target is 150 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (32% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04950894, a NA study of Obstructive Sleep Apnea and OSA, is active but no longer recruiting, sponsored by LivaNova.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The primary efficacy endpoint is to demonstrate that the AHI responder rate of subjects with the device stimulation activated (Active Group) is statistically significantly higher than the AHI responder rate of subjects with the device stimulation not activated (Control Group) at M7.
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 |
What the registry record for NCT04950894 still lists
NCT04950894 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (32% lower).
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.
NCT04950894 names 20 study sites across 14 states, led by Arizona, California, Florida.
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.
What interventions are being tested in trial NCT04950894?
The interventions under investigation include: Hypoglossal Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT04950894?
This trial is sponsored by LivaNova, which has 13 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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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 NCT04950894's enrollment target sits among peer trials
150 47th of 155 higher than 108 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea 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.
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