Status:
COMPLETED
Investigating the Experience of Living With Down Syndrome and Obstructive Sleep Apnea Syndrome (Stage 1)
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Down Syndrome
Obstructive Sleep Apnea
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief Summary
To identify the perceptions, beliefs, and family-relevant outcomes regarding the treatment of obstructive sleep apnea syndrome (OSAS) with positive airway pressure (PAP) in children with Down's Syndro...
Detailed Description
This is a multi-center outpatient study to be performed at two clinical sites: Children's Hospital of Philadelphia and Cincinnati Children's Hospital. Forty Caregivers of children with DS and OSAS tre...
Eligibility Criteria
Inclusion
- Inclusion Criteria -- Patients
- Children with DS and OSAS treated with PAP for at least 6 months
- Children aged between 6 and 17.5 years
- English proficiency
- Inclusion Criteria -- Caregivers
- Parent or legal guardian of an eligible patient subject
- English proficiency
- Must live with the patient subject at least 4 nights of the week
- Exclusion Criteria -- Patients
- In foster care
- Diagnosed with major illness, such as leukemia or severe cyanotic congenital heart disease listed for cardiac transplant as these severe diseases may add confounders
- Exclusion Criteria -- Caregivers
- Foster parent
Exclusion
Key Trial Info
Start Date :
August 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04124471
Start Date
August 2 2019
End Date
August 1 2022
Last Update
April 25 2023
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104