Clinical trial NCT03868618: Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Hypoglossal nerve stimulation
Lead sponsor: Nyxoah S.A.
Sponsor class: INDUSTRY
Collaborators: name: Nyxoah Inc.
First posted: 2019-03-11
Enrollment: 115
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Apnea Hypopnea Index (AHI4%)
timeFrame: 12 months
measure: Change in Oxyhemoglobin Desaturation Index (ODI4%)
timeFrame: 12 months
Secondary outcomes:
measure: FOSQ-10
timeFrame: 12 months
measure: SNORE-25
timeFrame: 12 months
measure: ESS
timeFrame: 12 months
measure: ODI4
timeFrame: 12 months
measure: SaO2 < 90%
timeFrame: 12 months
measure: AHI4
timeFrame: 12 months
Other outcomes:
measure: Safety Objectives
timeFrame: Observed during the study for a period of 12 months post-implantation.
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Boca Raton
country: United States
facility: ENT and Allegy Associates South Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida-Tampa General Medical Center
state: Florida
city: Atlanta
country: United States
facility: Advanced Ear Nose & Throat Associates
state: Georgia
city: Carmel
country: United States
facility: CENTA (Center for ENT & Allergy)
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa- Institute for Clinical & Translational Science
state: Iowa
city: Boston
country: United States
facility: Harvard/ Massachusetts Eye & Ear
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Medicine Otolaryngology - Head and Neck Surgery
state: New York
city: Columbus
country: United States
facility: The Ohio State University, Wexner Medical Center
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Department of Otolaryngology
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: The University of Tennessee Health Science Center- Dept. of Otolaryngology
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Wollongong
country: Australia
facility: Wollongong Private Hospital
state: New South Wales
city: Heidelberg
country: Australia
facility: Institute Breathing and Sleep Austin Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Hollywood Hospital
state: Western Australia
city: Antwerpen
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: München
country: Germany
facility: Technische Universität München
Study officials:
affiliation: Medical College of Wisconsin
name: Tucker Woodson, MD
role: PRINCIPAL_INVESTIGATOR
References: