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

NAActive, not recruitingINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

October 14, 2020

Primary Completion Date

February 20, 2024

Study Completion Date

February 29, 2028

Conditions
Obstructive Sleep Apnea
Interventions
DEVICE

Genio™ system

The Genio™ device is a permanent implant. It is implanted in the chin area and delivers stimulation to both hypoglossal nerve branches (i.e., the left and right branches). The implant does not include a battery or an embedded software and is externally powered.

Trial Locations (21)

2500

Wollongong Private Hospital, Wollongong

2650

Universitair Ziekenhuis Antwerpen, Antwerp

3084

Institute Breathing and Sleep Austin Hospital, Heidelberg

6005

Hollywood Hospital, Nedlands

10024

Weill Cornell Medicine Otolaryngology - Head and Neck Surgery, New York

19107

Thomas Jefferson University Department of Otolaryngology, Philadelphia

23298

Virginia Commonwealth University, Richmond

30342

Advanced Ear Nose & Throat Associates, Atlanta

33487

ENT and Allegy Associates South Florida, Boca Raton

33606

University of South Florida-Tampa General Medical Center, Tampa

35233

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nashville

38163

The University of Tennessee Health Science Center- Dept. of Otolaryngology, Memphis

43017

Ohio Sleep Medicine Institute, Dublin

43221

The Ohio State University, Wexner Medical Center, Columbus

46032

CENTA (Center for ENT & Allergy), Carmel

University of Pennsylvania, Philadelphia

52242

University of Iowa- Institute for Clinical & Translational Science, Iowa City

53226

Medical College of Wisconsin, Milwaukee

80333

Technische Universität München, München

02114

Harvard/ Massachusetts Eye & Ear, Boston

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Nyxoah Inc.

INDUSTRY

lead

Nyxoah S.A.

INDUSTRY

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