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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: Active NA study of Obstructive Sleep Apnea, sponsored by Nyxoah S.A..
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
percentage of responders at 12 months based on AHI4
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 |
What the registry record for NCT03868618 still lists
NCT03868618 is an interventional study that assigns participants to a tested intervention. The registered 115 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 (48% lower).
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 names 20 study sites across 16 states, led by 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.
Learn More About Clinical Trials
Similar trials for Obstructive Sleep Apnea
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 NCT03868618's enrollment target sits among peer trials
115 65th of 155 higher than 91 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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