Obstructive Sleep ApneaREST-HGN+ACNCT07303452
Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea
A study testing Neurostimulation in people with Obstructive Sleep Apnea, run by Restera, Inc. at 1 site in Australia.
Trial summary
The purpose of this multi-center proof-of-concept safety and efficacy study is to collect chronic sleep-related data following percutaneous placement of electrode arrays near the hypoglossal nerve and the ansa cervicalis in adults with obstructive sleep apnea. 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?
- Neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2025to May 2029
- 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) ≤ 32 kg/m2
- AHI between 15-65 events/hour
- Participants who have either not tolerated, have failed or refused positive airway pressure (PAP)
Who cannot join
- Pregnancy or breast-feeding
- Significant upper airway anatomic abnormalities
- Significant positionally-dependent OSA
- Participants taking medications that may alter body weight
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
University of Western Australia
Perth
About this study
Official title: A Multi-center Proof-of-concept Study to Assess the Safety and Effectiveness of the Restera™ Serene™ System When Stimulating the Hypoglossal Nerve Alone or the Hypoglossal Nerve Plus the Ansa Cervicalis Nerve for the Treatment of Obstructive Sleep Apnoea in Adult Participants.
The purpose of this multi-center proof-of-concept safety and efficacy study is to collect chronic sleep-related data following percutaneous placement of electrode arrays near the hypoglossal nerve and the ansa cervicalis in adults with obstructive sleep apnea.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Neurostimulation
- 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.
NeurostimulationDevice
Neurostimulation via Restera Serene System
| Study group | Role | What they receive |
|---|---|---|
| Single Target | Experimental | Not described Receives: Device: Neurostimulation |
| Dual Target | Experimental | Not described Receives: Device: Neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the Restera Serene System
Incidence of device and/or procedure-related serious adverse events
Measured: 6 months
Effectiveness of the Restera Serene System
Change from baseline in the Apnea-Hypopnea Index
Measured: 6 months
Secondary outcomes (2)
Long-term Safety of the Restera Serene System
Incidence of device and/or procedure-related serious adverse events
Measured: 36 months
Long-term Effectiveness of the Restera Serene System
Change from baseline in the Apnea-Hypopnea Index
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionMay 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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Restera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303452
- Sponsor's protocol ID
- IM-010
- Acronym
- REST-HGN+AC
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Proof-of-concept Study to Assess the Safety and Effectiveness of the Restera™ Serene™ System When Stimulating the Hypoglossal Nerve Alone or the Hypoglossal Nerve Plus the Ansa Cervicalis Nerve for the Treatment of Obstructive Sleep Apnoea in Adult Participants.
- ClinicalTrials.gov ID
- NCT07303452
- Acronym / sponsor ID
- REST-HGN+AC / IM-010
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Restera, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 24 Dec 2025 (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 purpose of this multi-center proof-of-concept safety and efficacy study is to collect chronic sleep-related data following percutaneous placement of electrode arrays near the hypoglossal nerve and the ansa cervicalis in adults with obstructive sleep apnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Target | Experimental | Device: Neurostimulation |
| Dual Target | Experimental | Device: Neurostimulation |
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) ≤ 32 kg/m2
- AHI between 15-65 events/hour
- Participants who have either not tolerated, have failed or refused positive airway pressure (PAP)
Key exclusion criteria (4 listed)
- Pregnancy or breast-feeding
- Significant upper airway anatomic abnormalities
- Significant positionally-dependent OSA
- Participants taking medications that may alter body weight
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 |
|---|---|---|
| NeurostimulationNeurostimulation via Restera Serene System | Device | Dual Target, Single Target |
Primary outcome
Safety of the Restera Serene System
Time frame: 6 months
Incidence of device and/or procedure-related serious adverse events
Effectiveness of the Restera Serene System
Time frame: 6 months
Change from baseline in the Apnea-Hypopnea Index
2 secondary outcomes
Long-term Safety of the Restera Serene System
Time frame: 36 months
Long-term Effectiveness of the Restera Serene System
Time frame: 36 months
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 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostimulation in people with Obstructive Sleep Apnea, run by Restera, Inc. at 1 site 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Tim Fayram (408-612-7570, tfayram@resterasleep.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the Restera Serene System (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 24 Dec 2025.