Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea
← catalyst calendarNCT04801771 · readout in 192 d
Sponsored by Inspire Medical Systems, Inc. (industry) · INSP — their whole pipeline →. With National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD).
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
57estimated
Sites
8
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-06-24 | actual | When the study began enrolling |
| Primary completion | 2027-02-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-09-30 | estimated | The whole study's end, after follow-up |
| First posted | 2021-03-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-09-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Down Syndrome
- Obstructive Sleep Apnea
Intervention
- Device: Inspire Upper Airway Stimulation (UAS) System — also filed as Hypoglossal nerve stimulation
Primary outcomes
what the primary-completion date above is the date OFChange in intelligence using the Kaufman Brief Intelligence Scale (KBIT-2)
measured 6 Months post-implant
Change in attention using the Wechsler Intelligence Scale
measured 6 Months post-implant
Change in processing speed using the Cambridge Neuropsychological Test Automated Battery (CANTAB)
measured 6 Months post-implant
Change in executive functioning using the Delis-Kaplan Executive Functioning System (DKEFS)
measured 6 Months post-implant
Change in learning and memory using the Cambridge Neuropsychological Test Automated Battery - Paired Associates Learning
measured 6 Months post-implant
Change in language using Expressive Language Sampling
measured 6 Months post-implant
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