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

NCT03868618 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CL-GEN-002033
• Study Type: interventional
• Target: 115
• Locations: 4 countries
• Sites: 21

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.

Conditions

Obstructive Sleep Apnea

Keywords

Hypoglossal nerve stimulation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• FOSQ-10

  12 months

• SNORE-25

  12 months

• ESS

  12 months

• ODI4

  12 months

• SaO2 < 90%

  12 months

Other Outcomes (1)

• Incidence of device-related SAEs

  Observed during the study for a period of 12 months post-implantation.

Study Arms (1)

Genio Therapy

EXPERIMENTAL

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

Device: Genio™ system

Interventions

Genio™ system DEVICE

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.

Genio Therapy

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 22 to 75 years (inclusive). Participant cannot be under guardianship, under curatorship or under judicial protection.
• Body mass index (BMI) ≤ 32 kg/m2.
• Cricomental space positive (≥ 0 cm). The cricomental space is the distance between the neck and the bisection of a line from the chin to the cricoid membrane when the head is in a neutral position.
• Has either not tolerated, has failed or refused positive airway pressure (PAP) treatment
• Moderate to severe OSA (15≤AHI4≤65 where combined central and mixed AHI \< 25% of the total AHI) based on a screening PSG.
• Non-supine AHI \> 10 events on the screening PSG or participant has either not tolerated, has failed or refused positional therapy.
• Written informed consent obtained from the participant prior to performing any study specific procedure.
• Willing and capable to comply with all study requirements, including specific lifestyle considerations, performing all follow-up visits and sleep studies, evaluation procedures and questionnaires for the whole duration of the trial.
• Willing to consent to long term follow-up of 5 years post-surgery.

You may not qualify if:

• Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment:
• Severe chronic insomnia
• Insufficient sleep syndrome (\<6 hours sleep per night)
• Narcolepsy
• Restless legs syndrome
• REM behavior disorder
• Others deemed sufficient disorders that would confound functional sleep assessment in the judgment of the investigator
• Night shift worker defined as individual working between the hours of 10:00 pm and 7:00 am at least 3 nights per working week.
• Taking medications that in the opinion of the investigator may alter consciousness, the pattern of respiration, or sleep architecture.
• Major anatomical or functional abnormalities that would impair the ability of the Genio System to treat OSA:
• Craniofacial abnormalities narrowing the airway or the implantation site
• Palatine tonsil size 3+ or 4+ by the Brodsky Classification
• Fixed upper airway obstructions (tumor, polyps, nasal obstruction)
• Congenital malformations in the airway
• Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateral unintended tongue deviation during protrusion)

Sponsors & Collaborators

• Nyxoah S.A.: lead
• Nyxoah Inc.: collaborator

Study Sites (21)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

ENT and Allegy Associates South Florida

Boca Raton, Florida, 33487, United States

Location

University of South Florida-Tampa General Medical Center

Tampa, Florida, 33606, United States

Location

Advanced Ear Nose & Throat Associates

Atlanta, Georgia, 30342, United States

Location

CENTA (Center for ENT & Allergy)

Carmel, Indiana, 46032, United States

Location

University of Iowa- Institute for Clinical & Translational Science

Iowa City, Iowa, 52242, United States

Location

Harvard/ Massachusetts Eye & Ear

Boston, Massachusetts, 02114, United States

Location

Weill Cornell Medicine Otolaryngology - Head and Neck Surgery

New York, New York, 10024, United States

Location

The Ohio State University, Wexner Medical Center

Columbus, Ohio, 43221, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

Location

Thomas Jefferson University Department of Otolaryngology

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 46032, United States

Location

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

Memphis, Tennessee, 38163, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Wollongong Private Hospital

Wollongong, New South Wales, 2500, Australia

Location

Institute Breathing and Sleep Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Hollywood Hospital

Nedlands, Western Australia, 6005, Australia

Location

Universitair Ziekenhuis Antwerpen

Antwerp, 2650, Belgium

Location

Technische Universität München

München, 80333, Germany

Location

Related Publications (2)

• Woodson BT, Kent DT, Huntley C, Hancock MK, Van Daele DJ, Boon MS, Huntley TC, Mickelson S, Gillespie MB, Suurna MV, Kacker A, Roy A, MacKay S, Withrow KP, Dedhia RC, Huyett P, Heiser C, Nicola SD, Makori F, Vanderveken OM, Padyha TA, Magalang UJ, Chio E, Kezirian EJ, Lewis R. Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial. J Clin Sleep Med. 2025 Nov 1;21(11):1883-1891. doi: 10.5664/jcsm.11822.

  PMID: 40702817 DERIVED

• Woodson BT, Suurna MV, Gillespie MB, Huntley TC, Hancock M, Santos A, Subbaroyan J, Makori F, Fesneau G, Heiser C, Kent DT. Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study. BMJ Open. 2024 Dec 20;14(12):e085218. doi: 10.1136/bmjopen-2024-085218.

  PMID: 39806685 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Tucker Woodson, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 11, 2019
• Study Start: October 14, 2020
• Primary Completion: February 20, 2024
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

DE (1); BE (1); US (16); AU (3)