Obstructive Sleep ApneaBETTER SLEEPNCT03763682
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse
A study testing Genio(TM) bilateral hypoglossal nerve stimulation system in people with Obstructive Sleep Apnea, run by Nyxoah S.A. at 4 sites in Australia.
Trial summary
The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5 months of treatment (i.e. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Genio(TM) bilateral hypoglossal nerve stimulation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesAustralia
- Study dates
- 10 Jan 2019to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Man or woman between 21 and 75 years of age
- Body mass index (BMI) ≤ 32 kg/m2
- Obstructive apnoea-hypopnea index (AHI) of 15-50 events/hour
- Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) treatments.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Institute Breathing and Sleep Austin Hospital
Heidelberg, Victoria, 3084
Hollywood Hospital
Nedlands, Western Australia, 6005
Westmead Private Hospital
Westmead, New South Wales, 2145
Wollongong Private Hospital
Wollongong, New South Wales, 2500
About this study
Official title: A Multicentre, Prospective, Open-label, 2 Groups Study to Assess the Safety and Performance of the Genio™ Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea in Adult Patients With and Without Complete Concentric Collapse of the Soft Palate
The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5 months of treatment (i.e. 6 months post-surgery) measured by the AHI, at rest to determine if there is a difference in performance between the two populations.
Read the detailed description
This is a prospective, open-label, multicentric, 2 groups study to assess the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate. Participants will be consented, enrolled and eligibility criteria checked. If the participant is eligible, participant will proceed with the Genio™ IS implantation. Six (6) weeks after implantation, the implant will be activated and study visits will be scheduled at Week 7, Month 2, Month 3, Month 4, Month 5 and Month 6.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Genio(TM) bilateral hypoglossal nerve stimulation system
- 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(TM) bilateral hypoglossal nerve stimulation systemDevice
Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Six (6) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4, 5 and 6 month(s) after implantation
| Study group | Role | What they receive |
|---|---|---|
| Genio(TM) system therapy | Experimental | Genio(TM) bilateral hypoglossal nerve stimulation system Receives: Device: Genio(TM) bilateral hypoglossal nerve stimulation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious device-related adverse events recorded during the study
Measured: 6 months
Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
Measured: Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
Secondary outcomes (2)
Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)
Measured: 6,12, 24, 36 months
Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)
Measured: 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start10 Jan 2019
- Primary completion28 Jun 2021
- Study completion18 Jun 2024
Why it stopped: The study was terminated due to operational challenges impacting protocol execution across sites.
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
- Model description
- prospective, open-label, 2 groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nyxoah S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763682
- Sponsor's protocol ID
- BETTER SLEEP
- Acronym
- BETTER SLEEP
- Status last verified
- May 2025
- First submitted
- 3 Dec 2018
- Last updated
- 6 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Open-label, 2 Groups Study to Assess the Safety and Performance of the Genio™ Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea in Adult Patients With and Without Complete Concentric Collapse of the Soft Palate
- ClinicalTrials.gov ID
- NCT03763682
- Acronym / sponsor ID
- BETTER SLEEP / BETTER SLEEP
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to operational challenges impacting protocol execution across sites.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Nyxoah S.A.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 4 Dec 2018 (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 explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5 months of treatment (i.e. 6 months post-surgery) measured by the AHI, at rest to determine if there is a difference in performance between the two populations.
Detailed description
This is a prospective, open-label, multicentric, 2 groups study to assess the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate. Participants will be consented, enrolled and eligibility criteria checked. If the participant is eligible, participant will proceed with the Genio™ IS implantation. Six (6) weeks after implantation, the implant will be activated and study visits will be scheduled at Week 7, Month 2, Month 3, Month 4, Month 5 and Month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, open-label, 2 groups
| Arm | Type | Receives |
|---|---|---|
| Genio(TM) system therapy | Experimental | Device: Genio(TM) bilateral hypoglossal nerve stimulation systemGenio(TM) bilateral hypoglossal nerve stimulation system |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Man or woman between 21 and 75 years of age
- Body mass index (BMI) ≤ 32 kg/m2
- Obstructive apnoea-hypopnea index (AHI) of 15-50 events/hour
- Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) treatments.
Key exclusion criteria (2 listed)
- 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
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(TM) bilateral hypoglossal nerve stimulation systemSubjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Six (6) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4, 5 and 6 month(s) after implantation | Device | Genio(TM) system therapy |
Primary outcome
Incidence of serious device-related adverse events recorded during the study
Time frame: 6 months
Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
Time frame: Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
2 secondary outcomes
Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)
Time frame: 6,12, 24, 36 months
Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)
Time frame: 12, 24, 36 months
Results and safety
The study was stopped early (reason given: The study was terminated due to operational challenges impacting protocol execution across sites.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genio(TM) bilateral hypoglossal nerve stimulation system in people with Obstructive Sleep Apnea, run by Nyxoah S.A. at 4 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 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 4 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?
The study was stopped early (reason given: The study was terminated due to operational challenges impacting protocol execution across sites.). Results are not available in the source record.
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 serious device-related adverse events recorded during the study (time frame: 6 months). The study lists 2 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 6 Jun 2025.