Pediatric Down Syndrome Post-Approval Study
← catalyst calendarNCT06851338 · readout ≤ 1,381 d
Sponsored by Inspire Medical Systems, Inc. (industry) · INSP — their whole pipeline →.
Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
60estimated
Sites
6
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 | Feb 2025 | estimated | When the study began enrolling |
| Primary completion | May 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2025-02-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-02-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Pediatric Obstructive Sleep Apnea
- Down Syndrome (DS)
Intervention
- Device: Hypoglossal Nerve Stimulation — also filed as Inspire Upper Airway Stimulation (UAS) System
Primary outcomes
what the primary-completion date above is the date OFSafety Outcome Measure - Procedure and Device-related Adverse events
measured Implant through 5 Years
Effectiveness Outcome Measure - Comparison of Baseline and Annual Apnea-Hypopnea Index (AHI)
measured Baseline and Annually through 5 Years post-implant
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