Pediatric Down Syndrome Post-Approval Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Inspire Medical Systems, Inc.
Study ID
NCT06851338
Status
Recruiting
Apply to this trial

Conditions

  • Down Syndrome (DS)
  • Pediatric Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
13 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.

Key Dates

Start date
Feb 28, 2025
Status verified
Feb 2025
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pediatric subjects with Down syndrome undergoing Inspire UAS Implant
    This study is a prospective, multi-center, single-arm study of pediatric subjects (age 13-18) with Down syndrome who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) system for the treatment of severe obstructive sleep apnea (OSA).

Primary Outcome Measure

Safety Outcome Measure - Procedure and Device-related Adverse events [ Time Frame: Implant through 5 Years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016
Chase Beckerman
[email protected]
Richard Law, MD
Children's Hospital Orange CountyOrangeCalifornia92868
Eric Rodriguez
[email protected]
Chana Chin, MD
University of South Florida Morsani College of MedicineTampaFlorida33602
Alex Czachor
[email protected]
Abhay Sharma, MD
Northwell Cohen Children's HospitalQueensNew York11040
Virginia Mullooly
[email protected]
Patrick Scheffler, MD
Cleveland Clinic FoundationClevelandOhio44195
Vaishal Shah, MD
Baylor College of Medicine/ Texas Children's HospitalHoustonTexas77030
Mary F Musso, MD

Find similar trials in Phoenix, AZ

By research site
Phoenix Children's Hospital· Phoenix, AZChildren's Hospital Orange County· Orange, CAUniversity of South Florida Morsani College of Medicine· Tampa, FLNorthwell Cohen Children's Hospital· Queens, NYCleveland Clinic Foundation· Cleveland, OHBaylor College of Medicine/ Texas Children's Hospital· Houston, TX

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