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NCT03868618 · ClinicalTrials.gov registry record · NA
Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)
A NA study of Obstructive Sleep Apnea, sponsored by Nyxoah S.A..
- Active
- Registry status
- NA
- Development phase
- 115
- Enrollment target
- 20
- Study locations
NCT03868618 is a NA study of Obstructive Sleep Apnea that is active but no longer recruiting, run by Nyxoah S.A.. The registered enrollment target is 115 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT03868618, a NA study of Obstructive Sleep Apnea, is active but no longer recruiting, sponsored by Nyxoah S.A..
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 115 participants
- Enrollment target
- 20
- Study locations
Study Summary
A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.
Conditions Studied
Interventions
- DEVICE Genio™ system
Study Locations (20)
Florida
- ENT and Allegy Associates South Florida - Boca Raton
- University of South Florida-Tampa General Medical Center - Tampa
Ohio
- The Ohio State University, Wexner Medical Center - Columbus
- Ohio Sleep Medicine Institute - Dublin
Pennsylvania
- Thomas Jefferson University Department of Otolaryngology - Philadelphia
- University of Pennsylvania - Philadelphia
Tennessee
- The University of Tennessee Health Science Center- Dept. of Otolaryngology - Memphis
- Vanderbilt University Medical Center - Nashville
Alabama
- University of Alabama at Birmingham - Birmingham
Georgia
- Advanced Ear Nose & Throat Associates - Atlanta
Indiana
- CENTA (Center for ENT & Allergy) - Carmel
Iowa
- University of Iowa- Institute for Clinical & Translational Science - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2020-10-14 |
| Est. Completion | 2028-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03868618
The ClinicalTrials.gov registry entry for NCT03868618 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 115 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 (48% lower). The listed sponsor is Nyxoah S.A., which has 2 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 Genio™ system is the first listed.
NCT03868618 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Florida, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03868618 about?
NCT03868618 is a clinical study titled "Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)". A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.
What is the current status of trial NCT03868618?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 115 participants. The study started on 2020-10-14. Estimated completion is 2028-02.
What conditions does trial NCT03868618 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT03868618?
The interventions under investigation include: Genio™ system (DEVICE).
Who is sponsoring clinical trial NCT03868618?
This trial is sponsored by Nyxoah S.A., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03868618 being conducted?
This trial has 20 study locations across Alabama, Florida, Georgia, Indiana, Iowa. 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
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.