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Completed
NCT04132999
Positive Airway Pressure (PAP) for Children With Down Syndrome (DS) and Obstructive Sleep Apnea Syndrome (OSAS)
Conditions: Down Syndrome, Obstructive Sleep Apnea
Sex: All
Ages: 6 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 27
Sponsor: University of Miami
Location: University of Miami Miami Florida
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.
Eligibility Criteria
Inclusion Criteria:
* Clinical referral for PAP initiation to treat OSAS
* Ages 6-18 years
* Children are able to cooperate with testing
* Have not used PAP for the past 3 years prior to enrollment
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT04132999). StuddyBuddy aggregates publicly available trial information.