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

NCT ID: NCT03868618

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-14
• Study Completion Date: 2028-02-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Genio Therapy

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

Group Type: EXPERIMENTAL

Genio™ system

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age from 22 to 75 years (inclusive). Participant cannot be under guardianship, under curatorship or under judicial protection.

2. Body mass index (BMI) ≤ 32 kg/m2.

3. 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.

4. Has either not tolerated, has failed or refused positive airway pressure (PAP) treatment

5. Moderate to severe OSA (15≤AHI4≤65 where combined central and mixed AHI < 25% of the total AHI) based on a screening PSG.

6. Non-supine AHI > 10 events on the screening PSG or participant has either not tolerated, has failed or refused positional therapy.

7. Written informed consent obtained from the participant prior to performing any study specific procedure.

8. 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.

9. Willing to consent to long term follow-up of 5 years post-surgery.

Exclusion Criteria

1. Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment:

1. Severe chronic insomnia

2. Insufficient sleep syndrome (<6 hours sleep per night)

3. Narcolepsy

4. Restless legs syndrome

5. REM behavior disorder

6. Others deemed sufficient disorders that would confound functional sleep assessment in the judgment of the investigator

2. 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.

3. Taking medications that in the opinion of the investigator may alter consciousness, the pattern of respiration, or sleep architecture.

4. Major anatomical or functional abnormalities that would impair the ability of the Genio System to treat OSA:

1. Craniofacial abnormalities narrowing the airway or the implantation site

2. Palatine tonsil size 3+ or 4+ by the Brodsky Classification

3. Fixed upper airway obstructions (tumor, polyps, nasal obstruction)

4. Congenital malformations in the airway

5. Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateral unintended tongue deviation during protrusion)

6. Existing swallowing difficulty as measured by a score of ≥3 on the EAT-10 questionnaire

7. Others deemed sufficient to impair the ability of the Genio® System to treat OSA in the judgment of the investigator

5. Significant comorbidities that contraindicate surgery or general anesthesia:

1. Revised Cardiac Risk Index Class III or IV

2. Persistent uncontrolled hypertension (defined as systolic pressure 160 mm Hg or a diastolic pressure of 120 mm Hg) despite medications

3. 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

4. Degenerative neurological disorder (i.e., Parkinson's disease, Alzheimer's disease)

5. Acute illness or infection

6. 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

7. Substance or alcohol abuse history within the previous 3 years. Alcohol and substance abuse are defined as follows:

i. Alcohol: no days with less than 3 or 4 standard drinks for women and men, respectively

ii. 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.

h) Life expectancy less than the primary endpoint study period (12 months post-surgery)

i) Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.

6. Prior surgery or treatments that could compromise the effectiveness of the Genio System:

1. Airway cancer surgery or radiation

2. Mandible or maxilla surgery in the previous 5 years (not counting dental treatments)

3. Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery)

4. Prior hypoglossal nerve stimulation device implantation

7. Has an Active Implantable Medical Device (AIMD) even if the device can be temporarily turned off.

8. Participation in another clinical study with an active treatment arm that could confound the results of the DREAM study.

9. Plan to become pregnant, currently pregnant, or breastfeeding during the study period.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nyxoah Inc.

INDUSTRY

Sponsor Role: collaborator

Nyxoah S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tucker Woodson, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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

Countries

United States; Australia; Belgium; Germany

References

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, di Nicola S, 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 Jul 24. doi: 10.5664/jcsm.11822. Online ahead of print.

Reference Type: DERIVED

PMID: 40702817 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39806685 (View on PubMed)

Other Identifiers

CL-GEN-002033

Identifier Type: -

Identifier Source: org_study_id