Clinical trialNCT04801771Active, not recruitingPhase 3Interventional

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

SponsorInspire Medical Systems, Inc.Enrollment57Down SyndromeObstructive Sleep Apnea

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Christopher Hartnick, MD
The Massachusetts Eye and Ear Infirmary
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Children'S Healthcare of Atlanta/ Emory University School of Medicine
Atlanta, Georgia, United States
Massachusetts General Hospital (mass Eye & Ear Infirmary)
Boston, Massachusetts, United States
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children'S Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern/children'S Hospital of Dallas
Dallas, Texas, United States
Children'S Hospital of the King'S Daughters/east Virginia Medical School
Norfolk, Virginia, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 24 Jun 2021
Primary completion: 28 Feb 2027
Completion: 30 Sept 2027
Last update posted: 18 Sept 2025
Registered enrollment: 57
Registry id: NCT04801771

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.