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

Primary Purpose

Obstructive Sleep Apnea

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Genio™ system
Sponsored by
Nyxoah S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Hypoglossal nerve stimulation

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • ENT and Allegy Associates South Florida
  • University of South Florida-Tampa General Medical Center
  • Advanced Ear Nose & Throat Associates
  • CENTA (Center for ENT & Allergy)
  • University of Iowa- Institute for Clinical & Translational Science
  • Harvard/ Massachusetts Eye & Ear
  • Weill Cornell Medicine Otolaryngology - Head and Neck Surgery
  • The Ohio State University, Wexner Medical Center
  • Ohio Sleep Medicine Institute
  • Thomas Jefferson University Department of Otolaryngology
  • University of Pennsylvania
  • The University of Tennessee Health Science Center- Dept. of Otolaryngology
  • Vanderbilt University Medical Center
  • Virginia Commonwealth University
  • Medical College of Wisconsin
  • Wollongong Private Hospital
  • Institute Breathing and Sleep Austin Hospital
  • Hollywood Hospital
  • Universitair Ziekenhuis Antwerpen
  • Technische Universität München

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Genio Therapy

Arm Description

The Genio™ system is an implantable neurostimulation system comprised of one implanted device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 7, 2019
Last Updated
April 18, 2023
Sponsor
Nyxoah S.A.
Collaborators
Nyxoah Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03868618
Brief Title
Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nyxoah S.A.
Collaborators
Nyxoah Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Hypoglossal nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genio Therapy
Arm Type
Experimental
Arm Description
The Genio™ system is an implantable neurostimulation system comprised of one implanted device
Intervention Type
Device
Intervention Name(s)
Genio™ system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of device-related SAEs
Description
Incidence of device-related SAEs recorded during the study for a period of 12 months post-surgery.
Time Frame
12 months
Title
Change in Apnea Hypopnea Index (AHI4%)
Description
percentage of responders at 12 months based on AHI4
Time Frame
12 months
Title
Change in Oxyhemoglobin Desaturation Index (ODI4%)
Description
percentage of responders at 12 months based on ODI4
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tucker Woodson, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
ENT and Allegy Associates South Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
University of South Florida-Tampa General Medical Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Advanced Ear Nose & Throat Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
CENTA (Center for ENT & Allergy)
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
University of Iowa- Institute for Clinical & Translational Science
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Harvard/ Massachusetts Eye & Ear
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Weill Cornell Medicine Otolaryngology - Head and Neck Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
Facility Name
The Ohio State University, Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Ohio Sleep Medicine Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Thomas Jefferson University Department of Otolaryngology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
46032
Country
United States
Facility Name
The University of Tennessee Health Science Center- Dept. of Otolaryngology
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Wollongong Private Hospital
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Institute Breathing and Sleep Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Hollywood Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Facility Name
Universitair Ziekenhuis Antwerpen
City
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Technische Universität München
City
München
ZIP/Postal Code
80333
Country
Germany

12. IPD Sharing Statement

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

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