Study of Inspire Upper Airway Stimulation for Severe Sleep Apnea in Adolescents with Down Syndrome

What this Trial Is About

Researchers are evaluating the ongoing safety and effectiveness of the Inspire Upper Airway Stimulation UAS system in adolescents and young adults aged 13 to 18 years with Down syndrome and severe obstructive sleep apnea OSA. This post-approval study focuses on this specific pediatric population to better understand how this device performs over time. The study involves implanting the Inspire UAS system in 60 participants across multiple centers. After the implant, participants will be followed for five years with regular visits to monitor safety and effectiveness. Data collected include sleep studies, therapy usage, quality of life questionnaires, and any adverse events related to the device or procedure. Participants will undergo assessments before the implant, including sleep studies and surgical consultations. Throughout the five-year follow-up, researchers will gather sleep data, monitor device use, and evaluate quality of life. The main outcomes measured are safety events and changes in sleep apnea severity annually. Participants will complete their involvement after their five-year follow-up visit.

Pediatric Down Syndrome Post-Approval Study