Inspire UAS for very severe OSA and higher-BMI adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a post-approval, observational study required by the FDA to collect long-term safety and effectiveness data after commercial use of the Inspire UAS system. The study enrolls adults with very severe OSA (65 ≤ AHI ≤ 100 events/hr) or those with moderate-to-severe OSA (15 ≤ AHI ≤ 100) and a BMI over 32 up to 40 kg/m2. Participants receive the commercially available Inspire implant and a patient remote and are followed with scheduled in-lab and at-home sleep studies, clinic visits, and questionnaires. Data will characterize outcomes and adverse events in this expanded patient population outside the original trial eligibility limits.

Why it matters

Who can join: the full rules

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.

Where it's running

• Colorado ENT & Allergy
  Colorado Springs, Colorado, United States Recruiting
• Florida Sleep Specialists
  Bradenton, Florida, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• University of Rochester
  Rochester, New York, United States Recruiting

Study contacts

• Study coordinator: Gwen Gimmestad
• Email: gwengimmestad@inspiresleep.com
• Phone: 763-392-9966

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.