Clinical Trial

Pediatric Post-Approval Registry

Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2020-06-30; most recent amendment 2025-02-24.
Status change: Not Yet Recruiting → Recruiting 2022-01-11
Trial Details
NCT Number NCT04457154
Lead Sponsor Inspire Medical Systems, Inc.
Conditions Obstructive Sleep Apnea
Enrollment 60 participants
Start Date 2021-11-30
Primary Completion 2027-12 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2025-02-25