Actively Recruiting
Pediatric Down Syndrome Post-Approval Study
Led by Inspire Medical Systems, Inc. · Updated on 2025-02-28
60
Participants Needed
6
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 been diagnosed with severe obstructive sleep apnea, with an AHI of 6 10 and 4 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG)
- Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance
- Patient is contraindicated for, or not effectively treated by, adenotonsillectomy
- Treatment of patient's OSA has followed standard of care in considering all other alternative/adjunctive therapies
- Patient, and their parents/guardians, is willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative in-lab sleep studies (PSGs), and questionnaire completion.
You will not qualify if you...
- Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
- Patient has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
- Patient has any condition or procedure that has compromised neurological control of the upper airway
- Patient, or their parent/guardian, is unable or does not have the necessary assistance to operate the patient remote
- Patient is pregnant or plans to become pregnant
- Patient has an implantable device that may be susceptible to unintended interaction with the Inspire system
- Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling
- Patient has a terminal illness with life expectancy of less than 12 months
- Any other reason the investigator deems the patient is unfit for participation in the study.
AI-Screening
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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
CONTACT
G
Gwen Gimmestad, VP Clinical
CONTACT
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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