Clinical Trial

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

Active, Not Recruiting Phase 3
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Summary
This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing implant of the Inspire Upper Airway Stimulation (UAS) System. The study is being conducted in order to evaluate objective change in cognition and expressive language after implant and therapy with the Inspire UAS System.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2021-03-12; most recent amendment 2025-09-17.
Status change: Recruiting → Active, Not Recruiting 2025-09-17
Status change: Not Yet Recruiting → Recruiting 2021-08-17
Trial Details
NCT Number NCT04801771
Lead Sponsor Inspire Medical Systems, Inc.
Collaborators: National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions Down Syndrome, Obstructive Sleep Apnea
Enrollment 57 participants
Start Date 2021-06-24
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-18