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NCT03868618 Clinical Trial

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

Obstructive Sleep Apnea Clinical Trial

— DREAM  

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03868618
Other study ID # CL-GEN-002033
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 14, 2020
Est. completion date February 2028

Study information
Verified date May 2024
Source Nyxoah S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 115
Est. completion date February 2028
Est. primary completion date February 20, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years to 75 Years
Eligibility Inclusion Criteria: - Body mass index (BMI) limitations - Likely suffer from moderate to severe OSA based on history and physical - Has either not tolerated, has failed or refused positive airway pressure (PAP) treatments - Willing and capable of providing informed consent Exclusion Criteria: - Inadequately treated sleep disorders other than OSA - Significant co-morbidities that contraindicates surgery or general anesthesia

Study Design

Related Conditions & MeSH terms

Intervention

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.

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

Sponsors (2)
Lead Sponsor Collaborator
Nyxoah S.A. Nyxoah Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of device-related SAEs Incidence of device-related SAEs recorded during the study for a period of 12 months post-surgery. 12 months
Primary Change in Apnea Hypopnea Index (AHI4%) percentage of responders at 12 months based on AHI4 12 months
Primary Change in Oxyhemoglobin Desaturation Index (ODI4%) percentage of responders at 12 months based on ODI4 12 months
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