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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03868618
Ethics application status
Date submitted
7/03/2019
Date registered
11/03/2019
Date last updated
19/04/2021

Titles & IDs
Public title
Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea
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 - Incidence of device-related SAEs recorded during the study for a period of 12 months post-surgery.
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Change in Apnea Hypopnea Index (AHI4%) - percentage of responders at 12 months based on AHI4
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Change in Oxyhemoglobin Desaturation Index (ODI4%) - percentage of responders at 12 months based on 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
Belgium
State/province [9] 0 0
Antwerpen
Country [10] 0 0
Germany
State/province [10] 0 0
München

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Nyxoah S.A.
Address
Country

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/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
Guillaume Raux, PhD
Address 0 0
Country 0 0
Phone 0 0
+32 10 22 23 55
Fax 0 0
Email 0 0
guillaume.raux@nyxoah.com
Contact person for scientific queries

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