Obstructive Sleep ApneaNCT02312479
Safety and Performance Study of the Nyxoah SAT System for Treating OSA
A study testing Nyxoah SAT system in people with Obstructive Sleep Apnea, run by Nyxoah S.A. at 2 sites in 2 countries.
Trial summary
A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Nyxoah SAT system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2014to Apr 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with moderate to severe Obstructive Sleep Apnea
- Have failed or have not tolerated CPAP treatment
- Willing and capable of providing informed consent
- Willing and capable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
Who cannot join
- BMI limits
- Subjects with complete concentric collapse at the soft palate level per endoscopy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Safety and Performance Study of the Use of the Nyxoah SAT System for the Treatment of Obstructive Sleep Apnea
A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Nyxoah SAT 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.
Nyxoah SAT systemDevice
The Nyxoah SAT system is comprised of an implantable nerve stimulator implanted over one of the tongue muscles via a minimally invasive procedure. Stimulation of the Hypoglossal nerves causes the tongue muscles to contract, thus maintaining an open airway during sleep.
| Study group | Role | What they receive |
|---|---|---|
| Nyxoah SAT therapy | Experimental | Not described Receives: Device: Nyxoah SAT 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
Measured: 6-months post-implantation
Mean change of AHI (Apnea-Hypopnea Index) measured by in-lab polysomnography (PSG) from baseline measurement to 6-months post-implantation
Measured: 6-months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionApr 2016
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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nyxoah S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joachim T Maurer, OA Dr. med., Principal investigator, Universitäts-HNO-Klinik MannheimEvert Hamans, PhD Dr., Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312479
- Sponsor's protocol ID
- SAT2014A
- Status last verified
- Sep 2016
- First submitted
- 4 Dec 2014
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Study of the Use of the Nyxoah SAT System for the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02312479
- Acronym / sponsor ID
- SAT2014A
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nyxoah S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 9 Dec 2014 (estimated)
- 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.
A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nyxoah SAT therapy | Experimental | Device: Nyxoah SAT system |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with moderate to severe Obstructive Sleep Apnea
- Have failed or have not tolerated CPAP treatment
- Willing and capable of providing informed consent
- Willing and capable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
Key exclusion criteria (2 listed)
- BMI limits
- Subjects with complete concentric collapse at the soft palate level per endoscopy
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 |
|---|---|---|
| Nyxoah SAT systemThe Nyxoah SAT system is comprised of an implantable nerve stimulator implanted over one of the tongue muscles via a minimally invasive procedure. Stimulation of the Hypoglossal nerves causes the tongue muscles to contract, thus maintaining an open airway during sleep. | Device | Nyxoah SAT therapy |
Primary outcome
Incidence of serious device related adverse events
Time frame: 6-months post-implantation
Mean change of AHI (Apnea-Hypopnea Index) measured by in-lab polysomnography (PSG) from baseline measurement to 6-months post-implantation
Time frame: 6-months post-implantation
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
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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.
Joachim T Maurer, OA Dr. med. principal investigator
Universitäts-HNO-Klinik Mannheim
Evert Hamans, PhD Dr. principal investigator
Universiteit Antwerpen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nyxoah SAT system in people with Obstructive Sleep Apnea, run by Nyxoah S.A. at 2 sites in 2 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 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 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Germany. 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. 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 (time frame: 6-months post-implantation). 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 27 Sep 2016.