Pediatric Down Syndrome Post-Approval Study

The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.

NCT Number	NCT06851338
Lead Sponsor	Inspire Medical Systems, Inc.
Conditions	Pediatric Obstructive Sleep Apnea, Down Syndrome (DS)
Enrollment	60 participants
Start Date	2025-02
Primary Completion	2030-05 (estimated)
Study Completion	2030-05 (estimated)
Updated on ClinicalTrials.gov	2025-02-28