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Sleep apnea device put to the test in heavier, more severe patients

NCT ID NCT07113288

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a device called Inspire, which is implanted in the body to treat obstructive sleep apnea. It is being studied in people with more severe sleep apnea (higher AHI) and higher body weight (higher BMI) who cannot use CPAP machines. The study will follow 70 participants over time to see if the device is safe and helps improve their breathing 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
Inspire® UAS System (implantable device)
What this could lead to
If successful, this could expand the use of the Inspire device to more people with severe sleep apnea and higher body weight, offering an alternative to CPAP machines.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The device requires surgery and may have side effects like discomfort or infection.

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 70 people

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

Started

Jul 2025

Expected to finish

Jan 2032

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.

Who is studied

A post-market sample selected from enrolling center's real-world patient population

Ages

18 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: 1. Subject is at least 18 years of age; 2. Subject has a diagnosis of severe OSA (65 ≤ AHI ≤ 100) based on a recent sleep study (within 12 months) OR Subject has a diagnosis of moderate to severe OSA (15≤AHI≤100) AND a baseline Body Mass Index of 32\<BMI≤40 kg/m2; 3. Subject has documented failure of, or intolerance to, positive airway pressure treatments (such as CPAP or BPAP machines; NOTE: PAP failure is defined as an inability to eliminate OSA (AHI \> 15 despite PAP usage). PAP intolerance is defined as the inability to use PAP (\> 5 nights per week, 4 hours of usage per night) or unwillingness to use PAP (e.g. patient returns the PAP system after attempting to use it). 4. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation; 5. Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the study; 6. Subject is willing and able to provide informed consent. Exclusion Criteria: 1. Subject has a combination of central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI) based on a recent sleep study (within 12 months); 2. Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate; 3. Subject has any condition or procedure that has compromised neurological control of the upper airway; 4. Subject is unable or does not have the necessary assistance to operate the patient remote; 5. Subject is pregnant or plans to become pregnant; 6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System; 7. Subject has a terminal illness with life expectancy \< 12 months; 8. Any other reason the investigator deems the subject is unfit for participation in the 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.

  1. The places running it

    5 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

  • Colorado ENT & Allergy

    RECRUITING

    Colorado Springs, Colorado, 80923, United States

  • Florida Sleep Specialists

    RECRUITING

    Bradenton, Florida, 34209, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

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