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

Running, not enrolling · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT03868618

Run by

Nyxoah S.A.

People needed

115

Starts

2020-10-14

Expected to finish

2028-02-01

Last updated by the study team

2026-04-14

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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)
• 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:

Where it is running

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

Full record on ClinicalTrials.gov

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