Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea
Condition(s) studied
Investigational drug(s) / intervention(s)
Inspire Upper Airway Stimulation (UAS) System: The Inspire UAS System is an implantable device that provides hypoglossal nerve stimulation for the treatment of obstructive sleep apnea.
Study 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.
Eligibility
Primary outcome measure(s)
- Change in intelligence using the Kaufman Brief Intelligence Scale (KBIT-2) — 6 Months post-implant
Change in the Intelligence Quotient Standard Score of at least 0.5 standard deviation from baseline - Change in attention using the Wechsler Intelligence Scale — 6 Months post-implant
Change in Cancellation scaled score of at least 0.5 standard deviation from baseline - Change in processing speed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) — 6 Months post-implant
Change in RTIFMDRT and RTIFMDMT raw scores of at least 0.5 standard deviation from baseline - Change in executive functioning using the Delis-Kaplan Executive Functioning System (DKEFS) — 6 Months post-implant
Change in Category Functioning scaled score of at least 0.5 standard deviation from baseline - Change in learning and memory using the Cambridge Neuropsychological Test Automated Battery - Paired Associates Learning — 6 Months post-implant
Change in PAL-TEA raw score of at least 0.5 standard deviation from baseline - Change in language using Expressive Language Sampling — 6 Months post-implant
Change in % of unintelligible C-units, number of different word roots and mean length of C-units in morphemes of at least 0.5 standard deviation from baseline
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Inspire Medical Systems, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04801771 on ClinicalTrials.gov ↗ ← All trials in the USA