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NCT04801771 · ClinicalTrials.gov registry record · Phase 3
Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea
A Phase 3 study of Obstructive Sleep Apnea and Down Syndrome, sponsored by Inspire Medical Systems.
- Active
- Registry status
- Phase 3
- Development phase
- 57
- Enrollment target
- 8
- Study locations
NCT04801771 is a Phase 3 study of Obstructive Sleep Apnea and Down Syndrome that is active but no longer recruiting, run by Inspire Medical Systems. The registered enrollment target is 57 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (74% lower). The trial reports 8 study locations across 7 states.
The verdict
NCT04801771, a Phase 3 study of Obstructive Sleep Apnea and Down Syndrome, is active but no longer recruiting, sponsored by Inspire Medical Systems.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 57 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing implant of the Inspire Upper Airway Stimulation (UAS) System. The study is being conducted in order to evaluate objective change in cognition and expressive language after implant and therapy with the Inspire UAS System.
Conditions Studied
Interventions
- DEVICE Inspire Upper Airway Stimulation (UAS) System
Study Locations (8)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh - Pittsburgh
Georgia
- Children's Healthcare of Atlanta/ Emory University School of Medicine - Atlanta
Massachusetts
- Massachusetts General Hospital (Mass Eye & Ear Infirmary) - Boston
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
Wisconsin
- University of Wisconsin School of Medicine and Public Health - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2021-06-24 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04801771
The ClinicalTrials.gov registry entry for NCT04801771 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 57 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 (74% lower). The listed sponsor is Inspire Medical Systems, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which Inspire Upper Airway Stimulation (UAS) System is the first listed.
NCT04801771 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Pennsylvania, Georgia, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04801771 about?
NCT04801771 is a clinical study titled "Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea". This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months af...
What is the current status of trial NCT04801771?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 57 participants. The study started on 2021-06-24. Estimated completion is 2027-09-30.
What conditions does trial NCT04801771 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Down Syndrome.
What interventions are being tested in trial NCT04801771?
The interventions under investigation include: Inspire Upper Airway Stimulation (UAS) System (DEVICE).
Who is sponsoring clinical trial NCT04801771?
This trial is sponsored by Inspire Medical Systems, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04801771 being conducted?
This trial has 8 study locations across Georgia, Massachusetts, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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