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New study aims to end guesswork in sleep apnea implant success

NCT ID NCT05429983

Knowledge-focused Sponsor: Johns Hopkins University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 60 people with moderate to severe sleep apnea who are being evaluated for a nerve stimulator implant (Inspire). During a routine sleep endoscopy, researchers will measure how the airway responds to direct muscle stimulation. They want to see if these measurements can predict who will have a good response to the implant, defined as a 50% reduction in apnea events. The goal is to improve patient selection and avoid implanting the device in people who won't benefit.

What this could mean

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

Active substance
hypoglossal nerve stimulation device (Inspire)
What this could lead to
If successful, this could help doctors better predict which sleep apnea patients will benefit from the Inspire device, reducing the number of people who get the implant but don't improve.
What could go wrong
This is an early-stage observational study with only 60 participants. The measurements may not reliably predict outcomes, and results may not apply to all patients.

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 60 people

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

Started

Nov 2022

Expected to finish

Nov 2028

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

Participants will be those undergoing drug-induced sleep endoscopy as part of routine clinical care for work up hypoglossal nerve stimulation therapy candidacy. All participants will have a confirmed diagnosis of obstructive sleep apnea with an apnea-hypopnea index \>15 and deemed to be intolerant of continuous positive airway pressure.

Ages

18 years and older

Sex

Anyone

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: * Male and female participants with moderate or severe sleep apnea (defined by \> 15 apneas and hypopneas per hour of sleep), who are undergoing DISE as part of routine evaluation for Inspire hypoglossal nerve stimulation therapy or for ineffective HGNS therapy. Exclusion Criteria: * Significant cardiac disease, unstable or recent cardiac events * Active pulmonary, liver or renal disease * Uncontrolled hypertension (BP\>160/100) * Neuromuscular disease * Major psychiatric disease * Pregnancy * Anticoagulation therapy (e.g. Coumadin, Dabigatran)

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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.

Sleep apnea, obstructive

How to take part

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

  1. The places running it

    1 site. 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

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

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