Obstructive Sleep Apnea of AdultOLENCT05939141
An Extension Study to Assess the Long-term Safety of the Genio® System
An observational study of Obstructive Sleep Apnea of Adult, run by Nyxoah S.A. at 7 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Genio System
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 7 sitesAustralia
- Study dates
- Nov 2025to 17 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sharondeep Gill contact
7 sites in 1 country
Australia7 sites
Complete ENT
Brisbane, Queensland, 4000
Leon Kitipornchai, MBBS
Leon Kitipornchai, MBBS
Institute for Breathing and Sleep (IBAS)
Melbourne, Victoria, 3084
Maree Barnes, MBBS
Maree Barnes, MBBS
Monash Health - Department of Respiratory and Sleep Medicine
Melbourne, Victoria, 3168
Darren Mansfield
Darren Mansfield, MBBS
Perth Head & Neck Surgery
Perth, Western Australia, 6009
Richard Lewis, MBBS
Richard Lewis, MBBS
The Woolcock Institute Of Medical Research
Sydney, New South Wales, 2037
Ronald Grunstein
Ronald Grunstein, MBBS
Westmead Public Hospital
Sydney, New South Wales, 2145
John Wheatley, MBBS
John Wheatley, MBBS
Illawarra ENT and Head & Neck Clinic
Sydney, New South Wales, 2500
Stuart MacKay, MBBS
Stuart MacKay, MBBS
About this study
Official title: 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.
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.
Read more
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.
Read the detailed description
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.
All subjects that have previously participated in a Nyxoah sponsored clinical investigation in Australia, and who are currently still implanted with an implantable stimulator (with therapy activated or de-activated) will be asked to participate in this long-term safety follow-up study and will be asked to report any (Serious) Adverse Device Effects and Device Deficiencies that may have occurred.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- Genio System
- Keywords
- OSA HGNS Hypoglossal Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genio SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Genio System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Yearly (until commercial availability of the device in Australia OR until no subjects remain implanted), anticipated average 5 years"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study startNov 2025 (estimated)
- Primary completion17 Jul 2029 (estimated)
- Study completion17 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nyxoah S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nyxoah Pty. Ltd.
- Responsible party
- Sponsor
- Investigators
- Richard Lewis, MBBS, Principal investigator, Perth Head & Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939141
- Sponsor's protocol ID
- CL-OLE2023
- Acronym
- OLE
- Status last verified
- May 2025
- First submitted
- 16 Jun 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05939141
- Acronym / sponsor ID
- OLE / CL-OLE2023
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- OSA HGNS Hypoglossal Nerve Stimulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Nyxoah S.A.Industry (pharma, biotech, devices)
- Collaborators
- Nyxoah Pty. Ltd.
- Study start
- Nov 2025 (estimated)
- Primary completion
- 17 Jul 2029 (estimated)
- Study completion
- 17 Jul 2029 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
All subjects that have previously participated in a Nyxoah sponsored clinical investigation in Australia, and who are currently still implanted with an implantable stimulator (with therapy activated or de-activated) will be asked to participate in this long-term safety follow-up study and will be asked to report any (Serious) Adverse Device Effects and Device Deficiencies that may have occurred.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OLE Subjects | – | Device: Genio Systemadult 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genio SystemAll 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. | Device | OLE Subjects |
Primary outcome
Long-term safety
Time frame: Yearly (until commercial availability of the device in Australia OR until no subjects remain implanted), anticipated average 5 years"
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sharondeep Gill contact
Richard Lewis, MBBS principal investigator
Perth Head & Neck Surgery
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea of Adult, run by Nyxoah S.A. at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Mans (+17633703594, Dan.Mans@Nyxoah.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety (time frame: Yearly (until commercial availability of the device in Australia OR until no subjects remain implanted), anticipated average 5 years"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.