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NCT04457154 · ClinicalTrials.gov registry record
Pediatric Post-Approval Registry
A clinical trial of Obstructive Sleep Apnea, sponsored by Inspire Medical Systems.
- Recruiting
- Registry status
- 60
- Enrollment target
- 8
- Study locations
NCT04457154 is a study of Obstructive Sleep Apnea that is actively recruiting participants, run by Inspire Medical Systems. The registered enrollment target is 60 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (73% lower). The trial reports 8 study locations across 7 states.
The verdict
NCT04457154, a study of Obstructive Sleep Apnea, is actively recruiting participants, sponsored by Inspire Medical Systems.
- RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 8
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2028-04 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (73% lower). The listed sponsor is Inspire Medical Systems, which has 8 total studies on file at ClinicalTrials.gov.
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.
NCT04457154 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Pennsylvania, Colorado, Georgia.
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.
What interventions are being tested in trial NCT04457154?
The interventions under investigation include: Inspire Upper Airway Stimulation System (DEVICE).
Who is sponsoring clinical trial NCT04457154?
This trial is sponsored by Inspire Medical Systems, which has 8 total clinical trials registered on ClinicalTrials.gov.
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.
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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.