RecruitingNCT04457154

Pediatric Post-Approval Registry

Inspire Pediatric Post-Approval Registry

Sponsor

Inspire Medical Systems, Inc.

Enrollment

60 participants

Start Date

Nov 30, 2021

Study Type

OBSERVATIONAL

Conditions

Obstructive Sleep Apnea

Summary

This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.

Eligibility

Min Age: 18 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Inspire Upper Airway Stimulation System for people with obstructive sleep apnea. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years to 21 Years.

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 Upper Airway Stimulation System

Implant of the Inspire Upper Airway Stimulation System

Locations(8)

Childrens Hospital of Colorado

Aurora, Colorado, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Duke University

Durham, North Carolina, United States

Cincinnati Childrens Hospital

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh

Sewickley, Pennsylvania, United States

University of Texas Southwestern/Children's Hospital of Dallas

Dallas, Texas, United States

Children's Hospital of the King's Daughters/East Virginia Medical School

Norfolk, Virginia, United States

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NCT04457154

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