πŸ›οΈ Verified NIH Record β€’ Updated 2026-04-09

Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM) (NCT03868618)

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

πŸ”΅ Active, Not Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: Nyxoah S.A.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham β€” Birmingham, Alabama

Age range: 22 Years to 75 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (21 Sites)

  • University of Alabama at Birmingham β€” Birmingham, Alabama
  • ENT and Allegy Associates South Florida β€” Boca Raton, Florida
  • University of South Florida-Tampa General Medical Center β€” Tampa, Florida
  • Advanced Ear Nose & Throat Associates β€” Atlanta, Georgia
  • CENTA (Center for ENT & Allergy) β€” Carmel, Indiana
  • University of Iowa- Institute for Clinical & Translational Science β€” Iowa City, Iowa
  • Harvard/ Massachusetts Eye & Ear β€” Boston, Massachusetts
  • Weill Cornell Medicine Otolaryngology - Head and Neck Surgery β€” New York, New York
  • The Ohio State University, Wexner Medical Center β€” Columbus, Ohio
  • Ohio Sleep Medicine Institute β€” Dublin, Ohio
  • Thomas Jefferson University Department of Otolaryngology β€” Philadelphia, Pennsylvania
  • University of Pennsylvania β€” Philadelphia, Pennsylvania
  • The University of Tennessee Health Science Center- Dept. of Otolaryngology β€” Memphis, Tennessee
  • Vanderbilt University Medical Center β€” Nashville, Tennessee
  • Virginia Commonwealth University β€” Richmond, Virginia
  • Medical College of Wisconsin β€” Milwaukee, Wisconsin
  • Wollongong Private Hospital β€” Wollongong, New South Wales
  • Institute Breathing and Sleep Austin Hospital β€” Heidelberg, Victoria
  • Hollywood Hospital β€” Nedlands, Western Australia
  • Universitair Ziekenhuis Antwerpen β€” Antwerp,
  • Technische UniversitΓ€t MΓΌnchen β€” MΓΌnchen,

πŸ’° 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 Β§ 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.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—