RecruitingNot ApplicableNCT06851338

Pediatric Down Syndrome Post-Approval Study

Sponsor

Inspire Medical Systems, Inc.

Enrollment

60 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Down Syndrome (DS)Pediatric Obstructive Sleep Apnea

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.

Eligibility

Min Age: 13 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Hypoglossal Nerve Stimulation for people with down syndrome (ds) and pediatric obstructive sleep apnea. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 13 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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