RecruitingObstructive Sleep Apnea

Pediatric Post-Approval Registry

Eligible age

18–21 yrs

Accepts

All genders

Locations

7 states

Healthy volunteers

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About this study

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.

Sponsor: Inspire Medical Systems, Inc.

You may qualify if…

✓ 1. Subject is between 18 and 21 years of age;
✓ 2. Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;
✓ 3. Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;
✓ 4. Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;
✓ 5. Subject has followed standard of care in considering all other alternative/adjunct therapies;
✓ 6. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
✓ 7. 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;
✓ 8. Subject is willing and able to provide informed consent.

You may not qualify if…

✕ 1. Subject has a combination of central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI);
✕ 2. 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;
✕ 3. Subject has any condition or procedure that has compromised neurological control of the upper airway;
✕ 4. Subject is unable, or does not have the necessary assistance, to operate the patient remote;
✕ 5. Subject is pregnant or plans to become pregnant;
✕ 6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
✕ 7. Subject has a terminal illness with life expectancy \< 12 months;
✕ 8. Any other reason the investigator deems the subject is unfit for participation in the registry.

Where it's recruiting

Aurora

Atlanta

Durham

Cincinnati

Philadelphia · Sewickley

Texas

Dallas

Virginia

Norfolk

Source: ClinicalTrials.gov · NCT04457154 · last updated 2025-02-25