Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 6 study locations across 6 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06851338
The ClinicalTrials.gov registry entry for NCT06851338 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inspire Medical Systems, which has 8 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.