Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea (NCT04801771)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Healthcare of Atlanta/ Emory University School of Medicine — Atlanta, Georgia
Age range: 10 Years to 21 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- Children's Healthcare of Atlanta/ Emory University School of Medicine — Atlanta, Georgia
- Massachusetts General Hospital (Mass Eye & Ear Infirmary) — Boston, Massachusetts
- Cincinnati Childrens Hospital — Cincinnati, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania
- University of Texas Southwestern/Children's Hospital of Dallas — Dallas, Texas
- Children's Hospital of the King's Daughters/East Virginia Medical School — Norfolk, Virginia
- University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Down Syndrome
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- Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD) — Ottawa, Ontario
- Executive Function Play Opportunities for Children With Down Syndrome — Fort Collins, Colorado
- Escalating Doses of Memantine in Down Syndrome (MEDS-123) — Cleveland, Ohio
- Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy — Bethesda, Maryland
Explore by condition: All Down Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.