Status:
RECRUITING
PAP for Children With DS and OSAS
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Down Syndrome
Obstructive Sleep Apnea
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
Determine the efficacy of family-informed intervention (INT) vs standard clinical care over a period of twelve months in children with obstructive sleep apnea and Down Syndrome.
Detailed Description
Evaluate the effect of PAP adherence on quality of life, neurobehavioral, and healthcare utilization in children with DS and OSAS. It is being hypothesized that, irrespective of study arm, increased P...
Eligibility Criteria
Inclusion
- Clinical referral for PAP initiation to treat OSAS
- Ages 6-18 years
- Children are able to cooperate with testing
- Naive to PAP treatment
Exclusion
- Major illnesses, such as leukemia or severe cyanotic congenital heart disease listed for cardiac transplant.
- Family planning to move out of the city within the next year
- Children in foster care
- Child with previously treated with PAP
- Caregivers who do not speak English well enough to complete behavioral and performance measures.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04132999
Start Date
March 1 2021
End Date
January 1 2026
Last Update
August 12 2025
Active Locations (3)
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1
University of Miami
Miami, Florida, United States, 33136
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
3
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104