Pediatric Post-Approval Registry

Recruiting now

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID: NCT04457154
Run by: Inspire Medical Systems, Inc.
People needed: 60
Starts: 2021-11-30
Expected to finish: 2028-04-01
Last updated by the study team: 2025-02-25

Who can join

Age: 18 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is between 18 and 21 years of age;
Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;
Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;
Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;
Subject has followed standard of care in considering all other alternative/adjunct therapies;
Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the registry;
Subject is willing and able to provide informed consent.

You may not qualify if…

Subject has a combination of central + mixed apneas > 25% of the total apnea-hypopnea index (AHI);
Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
Subject has any condition or procedure that has compromised neurological control of the upper airway;
Subject is unable, or does not have the necessary assistance, to operate the patient remote;
Subject is pregnant or plans to become pregnant;
Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
Subject has a terminal illness with life expectancy < 12 months;
Any other reason the investigator deems the subject is unfit for participation in the registry.

Where it is running

Children's Hospital of the King's Daughters/East Virginia Medical School — Norfolk, Virginia, United States (enrolling)
Childrens Hospital of Colorado — Aurora, Colorado, United States (enrolling)
Duke University — Durham, North Carolina, United States (enrolling)
Cincinnati Childrens Hospital — Cincinnati, Ohio, United States (enrolling)
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
Children's Hospital of Pittsburgh — Sewickley, Pennsylvania, United States (enrolling)
University of Texas Southwestern/Children's Hospital of Dallas — Dallas, Texas, United States (enrolling)
Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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