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Could a tiny implant cure your snoring? new trial tests nerve zap for sleep apnea

NCT ID NCT07049744

Disease control Sponsor: XII Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This pilot study tests a device implanted in the neck that stimulates nerves to keep the airway open during sleep. It is for adults with moderate to severe obstructive sleep apnea who cannot use a CPAP machine. The study will check if the device is safe and improves sleep quality in 30 participants over several months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XII Medical HGNS System (implantable nerve stimulator)
What this could lead to
If successful, this could offer a new treatment option for people with obstructive sleep apnea who cannot use a CPAP machine.
What could go wrong
This is a small early pilot study with only 30 participants, so results may not apply to everyone. The device requires surgery and carries risks like infection or nerve damage.

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

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

21 years and older

Sex

Anyone

Healthy volunteers

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

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 of 15-50 events/hour * Central + mixed apnea index ≤ 25% * 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 * Hypoglossal nerve weakness * Central sleep apnoea condition * Significant positionally-dependent OSA. * Complete concentric patterns of soft palate collapse on DISE * Inadequately treated non-OSA sleep disorder(s). * Significant co-morbidities or prior surgeries that contra-indicate a surgical procedure or general anesthesia * Taking medications that in the opinion of the investigator may alter consciousness, the pattern of respiration, or sleep architecture * Participants on a GLP-1

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obstructive sleep apnea (OSA)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Canberra ENT

    RECRUITING

    Canberra, Australian Capital Territory, Australia

  • Perth Head & Neck Surgery

    RECRUITING

    Perth, Western Australia, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Brisbane, Queensland, Australia

  • The Wollongong Hospital

    RECRUITING

    Wollongong, New South Wales, 2500, Australia

  • Westmead Hospital / Chris O'Brien Lifehouse

    RECRUITING

    Sydney, New South Wales, Australia

  • Woolcock Institute Of Medical Research

    RECRUITING

    Sydney, New South Wales, 2113, Australia

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