An Extension Study to Assess the Long-term Safety of the Genio® System
OLE
A Prospective, Open-label, Multicentric Extension Study to Assess the Long-term Safety of the Genio® System in Study Subjects Who Have Been Implanted With the Genio® Implantable Stimulator (IS) for the Treatment of OSA in Adult Patients.
1 other identifier
observational
39
1 country
7
Brief Summary
The objective of this study is to assess the long-term safety of the Genio® system in adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a Nyxoah sponsored Clinical Investigation. (Serious) Adverse Device Effects and Device Deficiencies in subjects previously implanted with a Nyxoah Genio implantable stimulator (IS) and having the IS still in-situ (with therapy activated or deactivated) will be collected. The main question it aims to answer is: what is the long term safety profile of the Genio System? Participants will be asked to refer back to the site per standard of care and report on any (Serious) Adverse Device Effects and Device Deficiencies that may have occurred.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2025
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2023
CompletedFirst Posted
Study publicly available on registry
July 11, 2023
CompletedStudy Start
First participant enrolled
November 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 17, 2029
June 4, 2025
May 1, 2025
3.7 years
June 16, 2023
June 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term safety
Long term safety of the Genio System as measured by the rate and type of Adverse Device Effects, Serious Adverse device Effects and Device Deficiencies overtime in subjects in Australia previously implanted with a Nyxoah Genio implantable stimulator (IS) and having the IS still in-situ (with therapy activated or deactivated).
Yearly (until commercial availability of the device in Australia OR until no subjects remain implanted), anticipated average 5 years"
Study Arms (1)
OLE Subjects
adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a Nyxoah sponsored Clinical Investigation and having the device in-situ at the time of enrollment (with therapy activated or de-activated).
Interventions
All participants have previously been implanted with a Genio® system implantable stimulator. This research is observational in nature (long term safety follow-up) and participants will not be exposed to additional procedures. The Genio System comprises of a bilateral Implantable Stimulator (IS), which is implanted via a minimally invasive surgery procedure and positioned over the genioglossus muscle with its electrodes positioned over both the left and right hypoglossal nerve branches. Stimulation of the hypoglossal nerve causes the tongue muscles to contract with the intention to maintain an open airway. The Implantable Stimulator receives energy pulses transmitted via the DP placed under the patient's chin and connected to the Activation Chip (AC), which contains the patient's stimulation parameters and contain a battery that provides energy.
Eligibility Criteria
Adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a Nyxoah sponsored Clinical Investigation in Australia.
You may qualify if:
- Subject voluntarily signed an Informed Consent Form
- Subject is currently implanted with a Genio® Implantable Stimulator (IS), with therapy active or inactive, and was included in and subsequently exited a Nyxoah sponsored clinical investigation (either by study completion or withdrawal). These studies include, but are not limited to BLAST OSA (CL-GEN-001203), BETTER SLEEP (CL-GEN-001908), DREAM (CL-GEN-002033) or, subject is currently implanted with a Genio® Implantable Stimulator (IS) and accessing therapy via the TGA special access scheme (SAS).
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nyxoah S.A.lead
- Nyxoah Pty. Ltd.collaborator
Study Sites (7)
The Woolcock Institute Of Medical Research
Sydney, New South Wales, 2037, Australia
Westmead Public Hospital
Sydney, New South Wales, 2145, Australia
Illawarra ENT and Head & Neck Clinic
Sydney, New South Wales, 2500, Australia
Complete ENT
Brisbane, Queensland, 4000, Australia
Institute for Breathing and Sleep (IBAS)
Melbourne, Victoria, 3084, Australia
Monash Health - Department of Respiratory and Sleep Medicine
Melbourne, Victoria, 3168, Australia
Perth Head & Neck Surgery
Perth, Western Australia, 6009, Australia
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Lewis, MBBS
Perth Head & Neck Surgery
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2023
First Posted
July 11, 2023
Study Start
November 1, 2025
Primary Completion (Estimated)
July 17, 2029
Study Completion (Estimated)
July 17, 2029
Last Updated
June 4, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share