Pediatric Down Syndrome Post-Approval Study
Key facts
- Where
- Cleveland, Houston, Orange, Phoenix, Queens, and Tampa, United StatesSee the 6 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 13 and 18 years old?
Source: NCT06851338, who can take part
Where in United States
- Cleveland Clinic FoundationCleveland, United StatesContact: Alex PiczerNot yet recruiting
- Baylor College of Medicine/ Texas Children's HospitalHouston, United StatesContact: Sadaf BatlaTaking people
- Children's Hospital Orange CountyOrange, United StatesContact: Eric RodriguezNot yet recruiting
- Phoenix Children s HospitalPhoenix, United StatesContact: Chase BeckermanNot yet recruiting
- Northwell Cohen Children's HospitalQueens, United StatesContact: Virginia MulloolyNot yet recruiting
- University of South Florida, Morsani College of MedicineTampa, United StatesContact: Alex CzachorNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Inspire Medical Systems, Inc.
- Trial code
- NCT06851338
- Record updated
- 28 February 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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 ≥ 10 and ≤ 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.
Exclusion: Patient has any condition or procedure that has compromised neurological control of the upper airway; Patient has a terminal illness with life expectancy of less than 12 months; 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, 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; Any other reason the investigator deems the patient is unfit for participation in the study.