NCT06851338View on ClinicalTrials.gov

Pediatric Down Syndrome Post-Approval Study

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

May 31, 2030

Study Completion Date

May 31, 2030

Conditions
Pediatric Obstructive Sleep ApneaDown Syndrome (DS)
Interventions
DEVICE

Hypoglossal Nerve Stimulation

Implant of Inspire Upper Airway Stimulation (UAS) system for treatment of obstructive sleep apnea (OSA) in the pediatric down syndrome population

Trial Locations (6)

11040

NOT_YET_RECRUITING

Northwell Cohen Children's Hospital, Queens

33602

NOT_YET_RECRUITING

University of South Florida Morsani College of Medicine, Tampa

44195

NOT_YET_RECRUITING

Cleveland Clinic Foundation, Cleveland

77030

RECRUITING

Baylor College of Medicine/ Texas Children's Hospital, Houston

85016

NOT_YET_RECRUITING

Phoenix Children's Hospital, Phoenix

92868

NOT_YET_RECRUITING

Children's Hospital Orange County, Orange

Sponsors
All Listed Sponsors
lead

Inspire Medical Systems, Inc.

INDUSTRY