Status:
ENROLLING_BY_INVITATION
Computer Models of Airways in Children and Young Adults With Sleep Apnea and Down Syndrome
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Down Syndrome
Obstructive Sleep Apnea
Eligibility:
All Genders
1-90 years
Brief Summary
The purpose of this research study is to develop a way of predicting with computers how surgery on the airway will affect night time breathing called Obstructive Sleep Apnea (OSA) in children with Dow...
Detailed Description
This is a proof-of-concept study to determine if a dynamic computational model can be used to predict surgical outcomes. If the results from the study are positive, they can be used to help design a l...
Eligibility Criteria
Inclusion
- All patients seen at CCHMC (up to 90 years of age) who are scheduled to have a clinical sleep MRI or CT scan for their OSA airway or lung disease.
- Both Sleep diagnostic tests (Sleep MRI and CT scans).
Exclusion
- Those patients whose body weight (\>350 pounds) or circumference is greater than what can be safely accommodated by the MRI scanner
- Patients with pacemakers or other non-MRI compatible devices
- Patients with extensive dental hardware that causes MR artifact obscuring visualization of the area of interest.
- Body Mass Index (BMI) \> 40
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01902407
Start Date
March 1 2011
End Date
December 1 2028
Last Update
September 29 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229