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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03868618




Registration number
NCT03868618
Ethics application status
Date submitted
7/03/2019
Date registered
11/03/2019
Date last updated
22/05/2024

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

Eligibility
Key inclusion criteria
- Body mass index (BMI) limitations

- Likely suffer from moderate to severe OSA based on history and physical

- Has either not tolerated, has failed or refused positive airway pressure (PAP)
treatments

- Willing and capable of providing informed consent
Minimum age
22 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inadequately treated sleep disorders other than OSA

- Significant co-morbidities that contraindicates surgery or general anesthesia

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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/ct2/show/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/ct2/show/NCT03868618