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

NCT07113288 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Obstructive Sleep Apnea (OSA)

Interventions

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.

Sponsors & Collaborators

  • Inspire Medical Systems, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2032-01-01
Completion
2032-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07113288 on ClinicalTrials.gov