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Obstructive Sleep ApneaDREAMNCT03868618

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

A study testing Genio™ system in people with Obstructive Sleep Apnea, run by Nyxoah S.A. at 21 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 22 to 75 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Genio™ system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
21 sitesin 4 countries
Study dates
14 Oct 2020to Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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)
  • Existing swallowing difficulty as measured by a score of ≥3 on the EAT-10 questionnaire
  • Others deemed sufficient to impair the ability of the Genio® System to treat OSA in the judgment of the investigator
  • Significant comorbidities that contraindicate surgery or general anesthesia:
  • Revised Cardiac Risk Index Class III or IV
  • Persistent uncontrolled hypertension (defined as systolic pressure 160 mm Hg or a diastolic pressure of 120 mm Hg) despite medications
  • Coagulopathy or required anticoagulant medications (such as warfarin, clopidogrel (Plavix) or similar; prophylactic aspirin not exclusionary) that cannot be safely stopped in the perioperative period
  • Degenerative neurological disorder (i.e., Parkinson's disease, Alzheimer's disease)
  • Acute illness or infection
  • Diagnosed psychiatric disease (e.g., psychotic illness, uncontrolled major depression or acute anxiety attacks) that prevents participant compliance with the requirements of the investigational study testing
  • Substance or alcohol abuse history within the previous 3 years. Alcohol and substance abuse are defined as follows:
  • Alcohol: no days with less than 3 or 4 standard drinks for women and men, respectively
  • Substance: the use of any substance in an amount unapproved by the investigator or considered illegal. The drugs most commonly abused include cocaine, marijuana, heroin (or substitution treatment), prescription drugs (especially painkillers), methamphetamines, and various other illegal substances.
  • Life expectancy less than the primary endpoint study period (12 months post-surgery)
  • Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
  • Prior surgery or treatments that could compromise the effectiveness of the Genio System:
  • Airway cancer surgery or radiation
  • Mandible or maxilla surgery in the previous 5 years (not counting dental treatments)
  • Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery)
  • Prior hypoglossal nerve stimulation device implantation
  • Has an Active Implantable Medical Device (AIMD) even if the device can be temporarily turned off.
  • Participation in another clinical study with an active treatment arm that could confound the results of the DREAM study.
  • Plan to become pregnant, currently pregnant, or breastfeeding during the study period.

Trial locations and contacts

21 sites in 4 countries.

21 sites in 4 countries

United States16 sites

  • Advanced Ear Nose & Throat Associates

    Atlanta, Georgia, 30342

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • ENT and Allegy Associates South Florida

    Boca Raton, Florida, 33487

  • Harvard/ Massachusetts Eye & Ear

    Boston, Massachusetts, 02114

  • CENTA (Center for ENT & Allergy)

    Carmel, Indiana, 46032

  • The Ohio State University, Wexner Medical Center

    Columbus, Ohio, 43221

  • Ohio Sleep Medicine Institute

    Dublin, Ohio, 43017

  • University of Iowa- Institute for Clinical & Translational Science

    Iowa City, Iowa, 52242

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

    Memphis, Tennessee, 38163

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Weill Cornell Medicine Otolaryngology - Head and Neck Surgery

    New York, New York, 10024

  • Thomas Jefferson University Department of Otolaryngology

    Philadelphia, Pennsylvania, 19107

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 46032

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • University of South Florida-Tampa General Medical Center

    Tampa, Florida, 33606

Other trials in United States

Australia3 sites

  • Institute Breathing and Sleep Austin Hospital

    Heidelberg, Victoria, 3084

  • Hollywood Hospital

    Nedlands, Western Australia, 6005

  • Wollongong Private Hospital

    Wollongong, New South Wales, 2500

Other trials in Australia

Belgium1 site

  • Universitair Ziekenhuis Antwerpen

    Antwerp, 2650

Other trials in Belgium

Germany1 site

  • Technische Universität München

    München, 80333

Other trials in Germany

About this study

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

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.

Being tested
Genio™ system
Keywords
Hypoglossal nerve stimulation
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genio™ systemDevice

    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.

Study groups in NCT03868618
Study groupRoleWhat they receive
Genio TherapyExperimentalThe Genio™ system is an implantable neurostimulation system comprised of one implanted device
Receives: Device: Genio™ system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Apnea Hypopnea Index (AHI4%)

    percentage of responders at 12 months based on AHI4

    Measured: 12 months

  2. Change in Oxyhemoglobin Desaturation Index (ODI4%)

    percentage of responders at 12 months based on ODI4

    Measured: 12 months

Secondary outcomes (6)

  1. FOSQ-10

    Mean change from baseline to the 12-month visit in FOSQ-10

    Measured: 12 months

  2. SNORE-25

    Mean change from baseline to the 12-month visit in SNORE-25

    Measured: 12 months

  3. ESS

    Mean change from baseline to the 12-month visit in ESS

    Measured: 12 months

  4. ODI4

    Mean change from baseline to the 12-month visit in ODI4

    Measured: 12 months

  5. SaO2 < 90%

    Mean change from baseline to the 12-month visit in SaO2 <90%

    Measured: 12 months

  6. AHI4

    Mean change from baseline to the 12-month visit in AHI4

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2019
  2. Study start14 Oct 2020
  3. Primary completion20 Feb 2024
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
115 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03868618
Sponsor's protocol ID
CL-GEN-002033
Acronym
DREAM
Status last verified
Apr 2026
First submitted
7 Mar 2019
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 40702817

  • 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.

    PubMed 39806685

Questions about this trial

What is this clinical trial studying?

A study testing Genio™ system in people with Obstructive Sleep Apnea, run by Nyxoah S.A. at 21 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Australia, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Apnea Hypopnea Index (AHI4%) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03868618, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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