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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03763682




Registration number
NCT03763682
Ethics application status
Date submitted
3/12/2018
Date registered
4/12/2018

Titles & IDs
Public title
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse
Scientific title
A Multicentre, Prospective, Open-label, 2 Groups Study to Assess the Safety and Performance of the Genio™ Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea in Adult Patients With and Without Complete Concentric Collapse of the Soft Palate
Secondary ID [1] 0 0
BETTER SLEEP
Universal Trial Number (UTN)
Trial acronym
BETTER SLEEP
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(TM) bilateral hypoglossal nerve stimulation system

Experimental: Genio(TM) system therapy - Genio(TM) bilateral hypoglossal nerve stimulation system


Treatment: Devices: Genio(TM) bilateral hypoglossal nerve stimulation system
Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Six (6) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4, 5 and 6 month(s) after implantation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of serious device-related adverse events recorded during the study
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
Timepoint [2] 0 0
Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
Secondary outcome [1] 0 0
Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)
Timepoint [1] 0 0
6,12, 24, 36 months
Secondary outcome [2] 0 0
Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)
Timepoint [2] 0 0
12, 24, 36 months

Eligibility
Key inclusion criteria
* Man or woman between 21 and 75 years of age
* Body mass index (BMI) = 32 kg/m2
* Obstructive apnoea-hypopnea index (AHI) of 15-50 events/hour
* Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) treatments.
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Unable or incapable of providing informed written consent
* Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Westmead Private Hospital - Westmead
Recruitment hospital [2] 0 0
Wollongong Private Hospital - Wollongong
Recruitment hospital [3] 0 0
Institute Breathing and Sleep Austin Hospital - Heidelberg
Recruitment hospital [4] 0 0
Hollywood Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
6005 - Nedlands

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03763682