RECRUITINGINTERVENTIONAL
PAP for Children With DS and OSAS
Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 2)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Clinical referral for PAP initiation to treat OSAS
- Ages 6-18 years
- Children are able to cooperate with testing
- Naive to PAP treatment
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
BEHAVIORAL
Family-informed intervention
Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team
BEHAVIORAL
Standard Clinical Care
Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.
Locations (3)
University of Miami
Miami, Florida, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States