Inspire UAS for very severe OSA and higher-BMI adults

Inspire UAS High AHI/High BMI Post-Approval Study

This study tests whether the implanted Inspire upper airway stimulation (UAS) system is safe and works long-term for adults with very severe obstructive sleep apnea or higher BMI who cannot use CPAP.

Quick facts

• Study type: Observational
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Inspire Medical Systems, Inc. (Industry-sponsored)
• Locations: 5 sites (Colorado Springs, Colorado and 4 other locations)
• Trial ID: NCT07113288 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older with severe OSA (65 ≤ AHI ≤ 100) or moderate-to-severe OSA (15 ≤ AHI ≤ 100) with BMI >32 to ≤40 kg/m2 who have failed or cannot tolerate PAP and are willing to be implanted and attend follow-up visits.

Not a fit: People who can use CPAP successfully, who have BMI >40 kg/m2, who have AHI >100 events/hr, or who are unwilling or unable to undergo implantation and follow-up are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this could offer a durable, implantable treatment option for adults with very severe OSA or higher BMI who cannot tolerate or use positive airway pressure.

How similar studies have performed: Previous clinical programs of the Inspire UAS system showed meaningful benefit in patients with lower AHI and BMI ranges, but this study expands into a less-studied, higher-AHI and higher-BMI population.

Eligibility criteria

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 this trial is running

Colorado Springs, Colorado and 4 other locations

• 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

Conditions Obstructive Sleep Apnea; OSA; Inspire; AHI