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NCT06851338 · ClinicalTrials.gov registry record · NA
Pediatric Down Syndrome Post-Approval Study
A NA study of Pediatric Obstructive Sleep Apnea and Down Syndrome (DS), sponsored by Inspire Medical Systems.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 6
- Study locations
NCT06851338: Recruiting NA study of Pediatric Obstructive Sleep Apnea and Down Syndrome (DS), sponsored by Inspire Medical Systems.
NCT06851338 is a NA study of Pediatric Obstructive Sleep Apnea and Down Syndrome (DS) that is actively recruiting participants, run by Inspire Medical Systems. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06851338, a NA study of Pediatric Obstructive Sleep Apnea and Down Syndrome (DS), is actively recruiting participants, sponsored by Inspire Medical Systems.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
Procedure-related and Device-related adverse events will be summarized by seriousness and severity. No formal hypothesis will be tested.
Conditions Studied
Interventions
- DEVICE Hypoglossal Nerve Stimulation
Study Locations (6)
Arizona
- Phoenix Children's Hospital - Phoenix
California
- Children's Hospital Orange County - Orange
Florida
- University of South Florida Morsani College of Medicine - Tampa
New York
- Northwell Cohen Children's Hospital - Queens
Ohio
- Cleveland Clinic Foundation - Cleveland
Texas
- Baylor College of Medicine/ Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-02 |
| Est. Completion | 2030-05 |
| Phase | NA |
What NCT06851338 shows while recruiting
NCT06851338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Pediatric Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which Hypoglossal Nerve Stimulation is the first listed.
NCT06851338 lists 6 locations in 6 states (Arizona, California, Florida).
Frequently Asked Questions
What is clinical trial NCT06851338 about?
NCT06851338 is a clinical study titled "Pediatric Down Syndrome Post-Approval Study". 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 ...
What is the current status of trial NCT06851338?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-02. Estimated completion is 2030-05.
What conditions does trial NCT06851338 study?
This clinical trial studies the following conditions: Pediatric Obstructive Sleep Apnea, Down Syndrome (DS).
What interventions are being tested in trial NCT06851338?
The interventions under investigation include: Hypoglossal Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT06851338?
This trial is sponsored by Inspire Medical Systems, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06851338 being conducted?
This trial has 6 study locations across Arizona, California, Florida, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pediatric Obstructive Sleep Apnea
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06851338's enrollment target sits among peer trials
60 1165th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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