New implant zaps nerves to treat sleep apnea without a mask
NCT ID NCT07303452
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a device called the Restora Serene System, which uses mild electrical pulses to stimulate nerves in the neck during sleep. The goal is to keep the airway open in people with obstructive sleep apnea who cannot use a CPAP machine. Twenty adults will be enrolled to see if the device is safe and reduces breathing pauses during sleep.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Restera Serene System (nerve stimulation device)
- What this could lead to
- If it works, this could offer a new treatment option for people with obstructive sleep apnea who cannot tolerate CPAP machines.
- What could go wrong
- This is a very small, early proof-of-concept study with only 20 participants. The device is still experimental, and it may not prove safe or effective enough for wider use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) Exclusion Criteria: * Pregnancy or breast-feeding * Significant upper airway anatomic abnormalities * Significant positionally-dependent OSA * Participants taking medications that may alter body weight
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Western Australia
RECRUITINGPerth, Australia
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