Sleep apnea device put to the test in heavier, more severe patients
NCT ID NCT07113288
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
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jan 2032
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.
Who is studied
A post-market sample selected from enrolling center's real-world patient population
- 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: 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.
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The places running it
5 sites. 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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Colorado ENT & Allergy
RECRUITINGColorado Springs, Colorado, 80923, United States
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Florida Sleep Specialists
RECRUITINGBradenton, Florida, 34209, United States
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Rush University Medical Center
RECRUITINGChicago, Illinois, 60612, United States
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University of Kansas Medical Center
RECRUITINGKansas City, Kansas, 66160, United States
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University of Rochester
RECRUITINGRochester, New York, 14642, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New mask aims to make sleep apnea therapy easier to live with
- Can a weekly phone call keep sleep apnea patients on CPAP?
- A smart neck brace may replace CPAP for sleep apnea
- A blood test for liver trouble may flag hidden risk in sleep apnea patients
- Blood oxygen dips may reveal who stays on CPAP
- Can a simple questionnaire improve sleep apnea treatment?