NCT07113288

Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study

Inspire UAS High AHI/High BMI Post-Approval Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Inspire Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
DEVICE	Inspire® UAS System	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.

Timeline

• Start date: 2025-07-31
• Primary completion: 2032-01-01
• Completion: 2032-01-01
• First posted: 2025-08-08
• Last updated: 2026-03-27

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study