clinical trial · NCT07113288
Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study
Inspire Medical Systems, Inc.·—·recruiting·n = 70
Obstructive Sleep Apnea (OSA)Inspire® UAS System
brief 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.
started
Jul 31, 2025
primary completion
Jan 1, 2032
completion
Jan 1, 2032
last updated
Mar 27, 2026
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.
official title
Inspire UAS High AHI/High BMI Post-Approval Study
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol