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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03763682
Ethics application status
Date submitted
3/12/2018
Date registered
4/12/2018
Date last updated
7/05/2019

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 months post implantation in Oxygen Desaturation Index (ODI)
Timepoint [1] 0 0
6 moinths
Secondary outcome [2] 0 0
Therapy response rate - Response is defined as a reduction in AHI from baseline to 6 months of 50% or higher and apnoea-hypopnea index (AHI) at 6 months less than 20.
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Change from baseline to 6 months post implantation in daytime sleepiness measured with Epworth Sleepiness Scale (ESS) - The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought. A reduction in ESS is considered a better outcome with a decrease of 2 points considered to be clinically significant.
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Sleep-related quality of life, measured by functional Outcomes of Sleep Questionnaire (FOSQ-10) score - The questionnaire assesses the impact of excessive sleepiness on functional outcomes relevant to daily behaviors and sleep-related quality of life. It uses a 4-point Likert response format (1= extreme difficulty to 4=no difficulty) for 5 subscales: 1) activity level (3 items), 2) vigilance(3 items), 3) intimacy and sexual relationships (1 item), 4) general productivity (2 items), and 5) social outcomes (1 item). A total score is calculated and an increase is considered an improvement.
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Change from baseline to 6 months post implantation in snoring intensity - Measured subjectively by the bed partner using a 5 point scale of no scoring, light snoring, medium snoring, very loud snoring, to leaving the bedroom.
Timepoint [5] 0 0
6 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
Gender
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
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
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
The objective of this study is to explore the safety and performance of the Genio™ system in
adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse
of the soft palate over a period of 4.5 months of treatment (i.e. 6 months post-surgery)
measured by the AHI, at rest to determine if there is a difference in performance between the
two populations.
Trial website
https://clinicaltrials.gov/show/NCT03763682
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
Charles Czank, PhD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
clinical@nyxoah.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03763682