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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/NCT03048604




Registration number
NCT03048604
Ethics application status
Date submitted
7/02/2017
Date registered
9/02/2017
Date last updated
11/10/2021

Titles & IDs
Public title
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
Scientific title
A Multicentre, Prospective, Open-label, Non-randomized, Single Arm Treatment Study to Assess the Safety, Performance and Initial Efficacy Trends of the Genio(TM) Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea.
Secondary ID [1] 0 0
BLAST OSA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea of Adult 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 -


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. Four (4) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4 and 6 month(s) after implantation.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety (Incidence of serious device-related adverse events)
Timepoint [1] 0 0
6-months post implantation
Primary outcome [2] 0 0
Performance
Timepoint [2] 0 0
6-months post implantation

Eligibility
Key inclusion criteria
Main

- Body mass index =32 kg/m2

- Patients who do not tolerate or do not accept positive airway pressure (PAP)
treatments.

- Obstructive apnoea-hypopnea index (AHI) of 20-60 events/hour

Main
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

- Significant co-morbidities making the patient unable or inappropriate to participate
in the trial

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/09/2018
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
Pert
Recruitment hospital [1] 0 0
Hollywood Private UWA Centre for Sleep Science Facility - Nedlands
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Paris
Country [2] 0 0
United Kingdom
State/province [2] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
The study is designed as a prospective, open-label, multicentre, non-randomized, single arm
treatment study to assess the safety, performance and initial efficacy trends of the GenioTM
System in patients with Obstructive Sleep Apnoea (OSA).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03048604
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Valérie Attali, Dr.
Address 0 0
La Pitié Salpêtrière, Paris
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/NCT03048604