🏛️ Verified NIH Record • Updated 2025-08-27
Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA. (NCT05592002)
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 Subjects With Complete Concentric Collapse of the Soft Palate.
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Nyxoah S.A.
🩺 Plain-English Summary (8th-Grade Level)
The solution offered by the Genio System to treat OSA patients with CCC using bilateral HGNS has a favorable risk-benefit ratio, as demonstrated by evidence from 2 studies.
Who can join: Review the eligibility criteria below.
Location: Colorado ENT & Allergy — Colorado Springs, Colorado
Age range: 22 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- Colorado ENT & Allergy — Colorado Springs, Colorado
- ENT and Allergy Associates of Florida, LLC — Boca Raton, Florida
- University of Miami — Miami, Florida
- PharmaDev Clinical Research Institute, — Miami, Florida
- University of South Florida — Tampa, Florida
- Center for ENT and Allergy, PC Ascension Medical Group — Carmel, Indiana
- University of Iowa Institute for Clinical & Translational Science — Iowa City, Iowa
- University of Kansas — Kansas City, Kansas
- Massachusetts Eye & Ear — Boston, Massachusetts
- University of Rochester — Rochester, New York
- Hospital of the University Pennsylvania — Philadelphia, Pennsylvania
- Thomas Jefferson University Department of Otolaryngology — Philadelphia, Pennsylvania
- Bogan Sleep Consultants, LLC — Columbia, South Carolina
- Vanderbilt University Medical Center — Nashville, Tennessee
- University of Texas Southwestern Medical Center — Dallas, Texas
- Eastern Virginia Medical School — Norfolk, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Sleep Apnea, Obstructive
- Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy With Stimulated Upper Airway Mechanics — Baltimore, Maryland
- Long-term Evaluation of a Nasopharyngeal Airway — Ann Arbor, Michigan
- The REPOSE (Reach for Equity in Pediatric Sleep Evaluation) Navigation Intervention — Charleston, South Carolina
- A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight — Cullman, Alabama
- The IPAD Cohort Study: Insomnia and Positive Airway Pressure Adherence in Children and Adolescents — Vancouver, British Columbia
Explore by condition: All Sleep Apnea, Obstructive clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.