NCT02344108View on ClinicalTrials.gov

A Pilot Study to Evaluate the Hypoglossal Nerve Stimulator in Adolescents With Down Syndrome and Obstructive Sleep Apnea

NACompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

July 23, 2021

Study Completion Date

September 2, 2021

Conditions
Sleep Apnea, ObstructiveDown Syndrome
Interventions
DEVICE

Inspire® Upper Airway Simulation System (Model 3028 IPG )

Subjects will be implanted with a hypoglossal nerve stimulator. Safety and efficacy of implantation will be evaluated.

Trial Locations (5)

15224

Children's Hospital of Pittsburgh, Pittsburgh

23507

Children's Hospital of The King's Daughters, Norfolk

30329

Children's Healthcare of Atlanta - Egleston Hospital, Atlanta

45229

Cincinnati Children's Hospital, Cincinnati

02115

Massachusetts Eye and Ear, Boston

Sponsors
All Listed Sponsors
collaborator

Emory University

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

Inspire Medical Systems, Inc.

INDUSTRY

collaborator

University of Pittsburgh

OTHER

collaborator

Children's Hospital of The King's Daughters

OTHER

lead

Christopher Hartnick, M.D.

OTHER

NCT02344108 - A Pilot Study to Evaluate the Hypoglossal Nerve Stimulator in Adolescents With Down Syndrome and Obstructive Sleep Apnea | Biotech Hunter | Biotech Hunter