Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

Pediatric Down Syndrome Post-Approval Study

NCT06851338 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 60 participants
Start Date 2025-02
Est. Completion 2030-05
Phase NA

Sponsor

Inspire Medical Systems

34 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical 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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06851338 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Arizona, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06851338?

The interventions under investigation include: Hypoglossal Nerve Stimulation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06851338?

This trial is sponsored by Inspire Medical Systems, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial