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New implant offers hope for sleep apnea patients who hate CPAP

NCT ID NCT06332404

Disease control Sponsor: University Hospital, Antwerp 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This registry follows 225 adults with moderate-to-severe obstructive sleep apnea who receive the Inspire hypoglossal nerve stimulation implant. The device is for people who cannot use CPAP, the standard treatment. Researchers will measure how well it reduces breathing pauses during sleep and how often patients actually use it in daily life.

What this could mean

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

Active substance
Inspire hypoglossal nerve stimulation device
What this could lead to
If successful, this registry could confirm that the Inspire device is a safe and effective long-term option for people with sleep apnea who cannot tolerate CPAP.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less definitive. The device requires surgery and may not work for everyone.

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.

Participants

About 225 people

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

Started

Apr 2024

Expected to finish

Apr 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Any patient implanted with or receiving HNS therapy in routine clinical care in Belgium and that is able to give informed consent is eligible to participate in the registry.

Ages

18 to 99 years

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: Any patient implanted with or receiving the Inspire HNS system and who is able to give informed consent is eligible to participate in the registry. A patient is eligible for HNS implantation if he/she meets the following criteria: * At least 18 years old at the time of implantation * The patient suffers from moderate to severe OSA (15 events/h ≤ AHI ≤ 65 events/h) * The patient has failed, not tolerated or has a contraindication for continuous positive airway pressure (CPAP) and/or mandibular advancement device (MAD) therapy * Absence of complete concentric collapse of the level of the soft palate during Drug-Induced Sleep Endoscopy (DISE) Exclusion Criteria: * Body mass index (BMI) \>32 kg/m². * Combined mixed and central AHI is more than 25% of the total AHI * Patients with complete concentric collapse at the level of the soft palate or any other anatomical deviation that could impede the proper functioning of HNS * Patients with severely impaired neurological control over the upper airway * Pregnancy * Surgery performed on the soft palate in the past three months before implantation.

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Conditions

The condition(s) this trial relates to.

Apnea obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

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

Apnea Obstructive sleep apnea Sleep apnea

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

  • AZ Sint-Jan Brugge

    RECRUITING

    Bruges, West-Vlaanderen, 8000, Belgium

  • Antwerp University Hospital

    RECRUITING

    Edegem, Antwerp, 2650, Belgium

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