Actively Recruiting
Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study
Led by Inspire Medical Systems, Inc. · Updated on 2026-03-27
70
Participants Needed
5
Research Sites
335 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.
CONDITIONS
Official Title
Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Diagnosis of severe obstructive sleep apnea (AHI between 65 and 100) based on a sleep study within 12 months OR diagnosis of moderate to severe OSA (AHI 15 to 100) with BMI over 32 and up to 40 kg/m2
- Documented failure or intolerance to positive airway pressure treatments such as CPAP or BPAP
- Willing and able to have the stimulation device implanted and use the patient remote each night
- Willing and able to attend follow-up visits, complete sleep studies and questionnaires
- Willing and able to provide informed consent
You will not qualify if you...
- Central plus mixed apneas greater than 25% of total AHI based on recent sleep study
- Anatomical issues that prevent effective upper airway stimulation, including complete concentric collapse of the soft palate
- Conditions or procedures compromising neurological control of the upper airway
- Unable or lacking assistance to operate the patient remote
- Pregnant or planning pregnancy
- Having implantable devices that could interfere with Inspire System
- Terminal illness with life expectancy less than 12 months
- Any condition that the investigator believes makes the subject unfit for the study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Colorado ENT & Allergy
Colorado Springs, Colorado, United States, 80923
Actively Recruiting
2
Florida Sleep Specialists
Bradenton, Florida, United States, 34209
Actively Recruiting
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
5
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
G
Gwen Gimmestad
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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