U.S., March 1 -- ClinicalTrials.gov registry received information related to the study (NCT06851338) titled 'Pediatric Down Syndrome Post-Approval Study' on Feb. 24.
Brief Summary: 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.
Study Start Date: Feb., 2025
Study Type: INTERVENTIONAL
Condition:
Pediatric Obstructive Sleep Apnea
Down Syndrome (DS)
Intervention:
DEVICE: Hypoglossal Nerve Stimulation
Implant of Inspire Upper Ai...