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RECRUITING

Pediatric Post-Approval Registry

NCT04457154 · View on ClinicalTrials.gov ↗

Study Summary

This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.

Conditions Studied

Interventions

  • DEVICE Inspire Upper Airway Stimulation System

Study Locations (8)

Pennsylvania

  • Children's Hospital of Philadelphia — Philadelphia
  • Children's Hospital of Pittsburgh — Sewickley

Colorado

  • Childrens Hospital of Colorado — Aurora

Georgia

  • Children's Healthcare of Atlanta — Atlanta

North Carolina

  • Duke University — Durham

Ohio

  • Cincinnati Childrens Hospital — Cincinnati

Texas

  • University of Texas Southwestern/Children's Hospital of Dallas — Dallas

Virginia

  • Children's Hospital of the King's Daughters/East Virginia Medical School — Norfolk

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-11-30
Est. Completion 2028-04

Sponsor

Inspire Medical Systems

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04457154

The ClinicalTrials.gov registry entry for NCT04457154 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention — of which Inspire Upper Airway Stimulation System 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: NCT04457154 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Pennsylvania, Colorado, Georgia. 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 NCT04457154 about?

NCT04457154 is a clinical study titled "Pediatric Post-Approval Registry". This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 yea...

What is the current status of trial NCT04457154?

This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2021-11-30. Estimated completion is 2028-04.

What conditions does trial NCT04457154 study?

This clinical trial studies the following conditions: Obstructive Sleep Apnea. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04457154?

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

Who is sponsoring clinical trial NCT04457154?

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 NCT04457154 being conducted?

This trial has 8 study locations across Colorado, Georgia, North Carolina, Ohio, Pennsylvania. 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