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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03868618




Registration number
NCT03868618
Ethics application status
Date submitted
7/03/2019
Date registered
11/03/2019
Date last updated
17/10/2024

Titles & IDs
Public title
Dual-sided Hypoglossal NeRvE StimulAtion for the TreatMent of Obstructive Sleep Apnea (DREAM)
Scientific 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
Secondary ID [1] 0 0
CL-GEN-002033
Universal Trial Number (UTN)
Trial acronym
DREAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Genio™ system

Experimental: Genio Therapy - The Genio™ system is an implantable neurostimulation system comprised of one implanted device


Treatment: Devices: 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 code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of device-related SAEs
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Change in Apnea Hypopnea Index (AHI4%)
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Change in Oxyhemoglobin Desaturation Index (ODI4%)
Timepoint [3] 0 0
12 months
Secondary outcome [1] 0 0
FOSQ-10
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
SNORE-25
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
ESS
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
ODI4
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
SaO2 < 90%
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
AHI4
Timepoint [6] 0 0
12 months

Eligibility
Key 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.
Minimum age
22 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2028
Actual
Sample size
Target
115
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Wollongong Private Hospital - Wollongong
Recruitment hospital [2] 0 0
Institute Breathing and Sleep Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Hollywood Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
6005 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Belgium
State/province [13] 0 0
Antwerpen
Country [14] 0 0
Germany
State/province [14] 0 0
München

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nyxoah S.A.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Nyxoah Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03868618
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tucker Woodson, MD
Address 0 0
Medical College of Wisconsin
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03868618