Back to resultsBiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
Primary Purpose
Obstructive Sleep Apnea of Adult
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Genio(TM) bilateral hypoglossal nerve stimulation system
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea of Adult
Eligibility Criteria
Main Inclusion Criteria:
- 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 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
Sites / Locations
- Hollywood Private UWA Centre for Sleep Science Facility
- La Pitié Salpêtrière - Paris
- Royal National Throat, Nose and Ear Hospital - London
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Genio(TM) system therapy
Arm Description
Outcomes
Primary Outcome Measures
Safety (Incidence of serious device-related adverse events)
Incidence of serious device-related adverse events
Performance
Change from baseline to 6-month post implantation in the apnoea-hypopnea index (AHI)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03048604
Brief Title
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
September 10, 2018 (Actual)
Study Completion Date
September 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nyxoah S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Genio(TM) system therapy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Genio(TM) bilateral hypoglossal nerve stimulation system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety (Incidence of serious device-related adverse events)
Description
Incidence of serious device-related adverse events
Time Frame
6-months post implantation
Title
Performance
Description
Change from baseline to 6-month post implantation in the apnoea-hypopnea index (AHI)
Time Frame
6-months post implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Attali, Dr.
Organizational Affiliation
La Pitié Salpêtrière, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hollywood Private UWA Centre for Sleep Science Facility
City
Nedlands
State/Province
Perth
Country
Australia
Facility Name
La Pitié Salpêtrière - Paris
City
Paris
Country
France
Facility Name
Royal National Throat, Nose and Ear Hospital - London
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31601716
Citation
Eastwood PR, Barnes M, MacKay SG, Wheatley JR, Hillman DR, Nguyen XL, Lewis R, Campbell MC, Petelle B, Walsh JH, Jones AC, Palme CE, Bizon A, Meslier N, Bertolus C, Maddison KJ, Laccourreye L, Raux G, Denoncin K, Attali V, Gagnadoux F, Launois SH. Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. Eur Respir J. 2020 Jan 9;55(1):1901320. doi: 10.1183/13993003.01320-2019. Print 2020 Jan.
Results Reference
derived
Learn more about this trial
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
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