Obstructive Sleep ApneaEliSANCT04031040
A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults
A study testing Genio® system therapy in people with Obstructive Sleep Apnea, run by Nyxoah S.A. at 19 sites in 5 countries.
Trial summary
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Genio® system therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 1 Sep 2019to Oct 2030
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) < 35 kg/m2
- AHI between 15 to 65 events/hour documented by the closest PSG performed at the time of the patient ICF signature and within maximum 12 months of screening and fulfilling the required technical criteria or during the screening phase.
- Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments.
Who cannot join
- Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment;
- Taking medication that in the opinion of the Investigator may alter consciousness, the pattern of respiration, or sleep architecture;
- Major anatomical or functional abnormalities that would impair the ability of the Genio® system to treat OSA;
- Inadequately treated psychiatric disease that prevent patient compliance with the requirements of the investigational study testing;
- Life expectancy < 12 months;
- Participation in another clinical study (excluding registries) during the study period (3 years).
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
France10 sites
CHU - Angers
Angers, 49933
Hôpital Henri-Mondor AP-HP
Créteil, 94010
Hôpital Privé La Louvière
Lille, 59800
Clinique Beau-Soleil
Montpellier, 34070
Hôpital Bichat, Assistance Publique - Hôpitaux de Paris
Paris, 75018
CEREVES Paris Jean Jaurès - Centre du sommeil
Paris, 75019
Hôpital Tenon AP-HP
Paris, 75020
Clinique Mutualiste de la Sagesse
Rennes, 35000
Polyclinique Saint Laurent
Rennes, 35700
CHU Toulouse
Toulouse, 31400
Germany5 sites
Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie
Hamburg, 21075
HNO-Klinik des Universitätsklinikums Jena
Jena, 07747
Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum
Mannheim, 68167
Klinikum rechts der Isar der TU München
München, 81675
Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
Wuppertal, 42283
Belgium2 sites
Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn
Antwerp, 2170
Universitair Ziekenhuis Antwerpen
Antwerp, 2650
Switzerland1 site
Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie
Liestal, 4410
About this study
Official title: A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults.
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.
Read the detailed description
This study is a multicenter, prospective single arm PMCF. Following activation of the Genio® system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Genio® system therapy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genio® system therapyDevice
Hypoglossal nerve stimulation system
| Study group | Role | What they receive |
|---|---|---|
| Genio® system therapy | Experimental | Following activation of the Genio® system at 8 weeks post-surgery, patients will be followed at 12 weeks, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Receives: Device: Genio® system therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device-related Serious Adverse Events (SADEs)
Incidence of device-related Serious Adverse Events (SADEs)
Measured: 12 months post-surgery
Change in Apnea-Hypopnea Index from baseline
Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab
Measured: 12 months post-surgery
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire (FOSQ)
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Sep 2019
- Primary completion30 Oct 2026 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nyxoah S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joachim T. Maurer, MD, Principal investigator, Klinik für HNO-Heilkunde, Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031040
- Sponsor's protocol ID
- CL-GEN-002068
- Acronym
- EliSA
- Status last verified
- Feb 2026
- First submitted
- 18 Jul 2019
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults.
- ClinicalTrials.gov ID
- NCT04031040
- Acronym / sponsor ID
- EliSA / CL-GEN-002068
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Nyxoah S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 24 Jul 2019 (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 primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.
Detailed description
This study is a multicenter, prospective single arm PMCF. Following activation of the Genio® system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genio® system therapy | Experimental | Device: Genio® system therapyFollowing activation of the Genio® system at 8 weeks post-surgery, patients will be followed at 12 weeks, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) < 35 kg/m2
- AHI between 15 to 65 events/hour documented by the closest PSG performed at the time of the patient ICF signature and within maximum 12 months of screening and fulfilling the required technical criteria or during the screening phase.
- Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments.
Key exclusion criteria (6 listed)
- Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment;
- Taking medication that in the opinion of the Investigator may alter consciousness, the pattern of respiration, or sleep architecture;
- Major anatomical or functional abnormalities that would impair the ability of the Genio® system to treat OSA;
- Inadequately treated psychiatric disease that prevent patient compliance with the requirements of the investigational study testing;
- Life expectancy < 12 months;
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® system therapyHypoglossal nerve stimulation system | Device | Genio® system therapy |
Primary outcome
Incidence of device-related Serious Adverse Events (SADEs)
Time frame: 12 months post-surgery
Incidence of device-related Serious Adverse Events (SADEs)
Change in Apnea-Hypopnea Index from baseline
Time frame: 12 months post-surgery
Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire
Time frame: 12 months post-surgery
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire (FOSQ)
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 Mar 2026.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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. This study is not recruiting at the moment.
Joachim T. Maurer, MD principal investigator
Klinik für HNO-Heilkunde, Mannheim
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genio® system therapy in people with Obstructive Sleep Apnea, run by Nyxoah S.A. at 19 sites in 5 countries.
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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Germany, Belgium, Netherlands, Switzerland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of device-related Serious Adverse Events (SADEs) (time frame: 12 months post-surgery). The study lists 3 primary outcomes in all. 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 Mar 2026.