Actively Recruiting
Pediatric Down Syndrome Post-Approval Study of Inspire Upper Airway Stimulation System for Severe Obstructive Sleep Apnea
Led by Inspire Medical Systems, Inc. · Updated on 2025-02-28
60
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the ongoing safety and effectiveness of the Inspire Upper Airway Stimulation (UAS) system in adolescents and young adults aged 13 to 18 years with Down syndrome and severe obstructive sleep apnea (OSA). This post-approval study focuses on this specific pediatric population to better understand how this device performs over time. The study involves implanting the Inspire UAS system in 60 participants across multiple centers. After the implant, participants will be followed for five years with regular visits to monitor safety and effectiveness. Data collected include sleep studies, therapy usage, quality of life questionnaires, and any adverse events related to the device or procedure. Participants will undergo assessments before the implant, including sleep studies and surgical consultations. Throughout the five-year follow-up, researchers will gather sleep data, monitor device use, and evaluate quality of life. The main outcomes measured are safety events and changes in sleep apnea severity annually. Participants will complete their involvement after their five-year follow-up visit.
CONDITIONS
Brief Title
Pediatric Down Syndrome Post-Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has been diagnosed with Down syndrome
- Patient is 13-18 years of age
- Patient has severe obstructive sleep apnea with an apnea-hypopnea index (AHI) between 10 and 50 based on a recent in-lab sleep study
- Patient has failed or cannot tolerate positive airway pressure therapies such as CPAP or BiPAP
- Patient is not effectively treated by or is contraindicated for adenotonsillectomy
- Patient's treatment has followed standard care considering all alternative therapies
- Patient and their parents/guardians agree to permanent device implantation and participation in follow-up visits, sleep studies, and questionnaires
You will not qualify if you...
- Central plus mixed apneas make up more than 25% of total AHI on recent sleep study
- Anatomical issues that would affect upper airway stimulation performance, such as complete concentric collapse of the soft palate
- Conditions or procedures compromising neurological control of the upper airway
- Patient or guardian unable to operate the patient remote
- Patient is pregnant or plans to become pregnant
- Presence of an implantable device that may interfere with the Inspire system
- Need for MRI scans not allowed by the device's MRI conditional labeling
- Terminal illness with life expectancy under 12 months
- Any other investigator-determined reasons making the patient unfit for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 day
Participants undergo implant of the Inspire Upper Airway Stimulation (UAS) system for treatment of severe obstructive sleep apnea.
1 implant visit (in-person)
Duration - 5 years
Participants are followed for 5 years after implant to assess safety and effectiveness, including collection of safety information, sleep data, therapy usage, and quality of life at multiple follow-up visits.
Multiple follow-up visits annually over 5 years
Trial Site Locations
Total: 6 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Not Yet Recruiting
2
Children's Hospital Orange County
Orange, California, United States, 92868
Not Yet Recruiting
3
University of South Florida Morsani College of Medicine
Tampa, Florida, United States, 33602
Not Yet Recruiting
4
Northwell Cohen Children's Hospital
Queens, New York, United States, 11040
Not Yet Recruiting
5
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
6
Baylor College of Medicine/ Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Angela Chapin, Sr. Clinical Study Manager
G
Gwen Gimmestad, VP Clinical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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