124
Participants
Start Date
December 28, 2022
Primary Completion Date
September 30, 2026
Study Completion Date
September 30, 2028
Genio System
The Genio® IS electrode placement does not require an extensive surgical manipulation of the hypoglossal nerve, it requires only a single incision site and does not require battery replacements as those are external components. Whereas UPPP surgery and other similar upper airway enlargement surgeries are much more extensive, are irreversible and tend to have more complications and modest long-term results in reducing OSA severity and symptoms. In summary, 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.
University of Rochester, Rochester
Hospital of the University Pennsylvania, Philadelphia
Thomas Jefferson University Department of Otolaryngology, Philadelphia
Eastern Virginia Medical School, Norfolk
Bogan Sleep Consultants, LLC, Columbia
University of Miami, Miami
PharmaDev Clinical Research Institute,, Miami
ENT and Allergy Associates of Florida, LLC, Boca Raton
University of South Florida, Tampa
Vanderbilt University Medical Center, Nashville
Center for ENT and Allergy, PC Ascension Medical Group, Carmel
University of Iowa Institute for Clinical & Translational Science, Iowa City
University of Kansas, Kansas City
University of Texas Southwestern Medical Center, Dallas
Colorado ENT & Allergy, Colorado Springs
Massachusetts Eye & Ear, Boston
Lead Sponsor
Collaborators (1)
Nyxoah Inc.
INDUSTRY
Nyxoah S.A.
INDUSTRY