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ACTIVE NOT RECRUITING Phase 3

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

NCT04801771 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 57 participants
Start Date 2021-06-24
Est. Completion 2027-09-30
Phase Phase 3

Sponsor

Inspire Medical Systems

34 total trials

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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. It is categorized as Phase 3, 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 57 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 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. 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: NCT04801771 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Pennsylvania, Georgia, Massachusetts. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04801771?

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

Who is sponsoring clinical trial NCT04801771?

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 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.

Related

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