Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study
Start Date
7/31/2025
Completion Date
1/1/2032
Summary
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.
Detailed Description
This post-approval study is a condition of FDA approval and will collect long-term safety and effectiveness data on an expanded population that includes patients with very severe obstructive sleep apnea (65\<AHI≤100 events/hr), as well as those with a higher BMI (32\<BMI≤40 kg/m2). Participants will be implanted with a commercially available Inspire UAS System. In addition, participants will receive a patient remote which is used to initiate therapy each night.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Inspire® UAS System
Conditions
Locations
Colorado ENT & Allergy
Colorado Springs, Colorado 80923
United States
Florida Sleep Specialists
Bradenton, Florida 34209
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
University of Rochester
Rochester, New York 14642
United States