Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 2)
University of Miami
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.
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 PAP adherence will be associated with better quality of life, neurobehavioral, and healthcare utilization outcomes. Evaluate the effect of PAP adherence in children with DS and OSAS on patient-centered outcomes and family-relevant outcomes identified during the R61 phase of this research. It is being hypothesized that irrespective of study arm, increased PAP adherence will be associated with bette…
Eligibility
- Age range
- 6–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Clinical referral for PAP initiation to treat OSAS * Ages 6-18 years * Children are able to cooperate with testing * Naive to PAP treatment 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.
Interventions
- BehavioralFamily-informed intervention
Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team
- BehavioralStandard Clinical Care
Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.
Locations (3)
- University of MiamiMiami, Florida
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- The Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania