Long-term safety study of Inspire implant for severe sleep apnea

Plain-English translation of NCT07113288 on ClinicalTrials.gov ↗ · Source last updated March 2026 · Translation generated June 2026 · How we translate trials

What is this trial?

This trial is testing the Inspire UAS System—a small implanted device that stimulates throat muscles during sleep to keep airways open—in patients with very severe sleep apnea or those with moderate-to-severe sleep apnea plus higher body weight. The study will follow participants for 5 years to make sure the implant is safe and works well in these groups.

The FDA approved this device for certain sleep apnea patients, but wants more information about how it performs in people with the most severe cases or those with higher body weight. This study will gather that long-term safety and effectiveness data.

Do you qualify?

You likely qualify if…

you are at least 18 years old
you have been diagnosed with severe sleep apnea (very frequent breathing pauses during sleep) within the past 12 months, or moderate-to-severe sleep apnea combined with a higher body mass index
you have tried or tried to use continuous positive airway pressure (CPAP or BIPAP machines) but it did not work well enough or you could not tolerate it
you are willing to have a small device surgically implanted under your skin and use a remote control to turn it on each night
you can commit to returning for follow-up visits and sleep studies over 5 years

You likely don't qualify if…

you have certain types of central or mixed apneas making up more than 25% of your total breathing events
you have anatomical features of your throat that would prevent the device from working properly
you have a condition affecting nerve control of your upper airway
you are pregnant or planning to become pregnant during the study
you have another implanted medical device that could interfere with the Inspire System

What participation looks like

You would have the Inspire device surgically implanted, then use a patient remote control to activate it each night before sleep. Over the next 5 years, you will return for regular follow-up visits, complete sleep studies (both in a lab and at home), and answer questionnaires about your symptoms and quality of life. The study is designed to ensure the device remains safe and effective for people in your situation.

AI-generated summary from trial data · Jun 6, 2026 · Not medical advice

Trial locations(5 sites)

United States

Colorado ENT & Allergy, Colorado Springs, Colorado

Florida Sleep Specialists, Bradenton, Florida

Rush University Medical Center, Chicago, Illinois

University of Kansas Medical Center, Kansas City, Kansas

University of Rochester, Rochester, New York