RecruitingNCT07113288

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

Inspire UAS High AHI/High BMI Post-Approval Study

Sponsor

Inspire Medical Systems, Inc.

Enrollment

70 participants

Start Date

Jul 31, 2025

Study Type

OBSERVATIONAL

Conditions

Obstructive Sleep Apnea (OSA)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Inspire® UAS System for people with obstructive sleep apnea (osa). The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEInspire® 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.