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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Genio™ system

• Study Type: Interventional
• Enrollment (Estimated): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Wollongong, New South Wales, Australia, 2500
      • Wollongong Private Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Institute Breathing and Sleep Austin Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6005
      • Hollywood Hospital
• Belgium
  • Antwerpen, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
• Germany
  • München, Germany, 80333
    • Technische Universität München
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Florida
    • Boca Raton, Florida, United States, 33487
      • ENT and Allegy Associates South Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida-Tampa General Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Advanced Ear Nose & Throat Associates
  • Indiana
    • Carmel, Indiana, United States, 46032
      • CENTA (Center for ENT & Allergy)
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa- Institute for Clinical & Translational Science
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Harvard/ Massachusetts Eye & Ear
  • New York
    • New York, New York, United States, 10024
      • Weill Cornell Medicine Otolaryngology - Head and Neck Surgery
  • Ohio
    • Columbus, Ohio, United States, 43221
      • The Ohio State University, Wexner Medical Center
    • Dublin, Ohio, United States, 43017
      • Ohio Sleep Medicine Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Department of Otolaryngology
    • Philadelphia, Pennsylvania, United States, 46032
      • University of Pennsylvania
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • The University of Tennessee Health Science Center- Dept. of Otolaryngology
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College Of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genio Therapy; The Genio™ system is an implantable neurostimulation system comprised of one implanted device	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nyxoah S.A.
• Collaborators: Nyxoah Inc.
• Investigators: Principal Investigator: Tucker Woodson, MD, Medical College Of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Actual): February 20, 2024
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Hypoglossal nerve stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: CL-GEN-002033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes