Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 2)
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:
• Clinical referral for PAP initiation to treat OSAS
• Ages 6-18 years
• Children are able to cooperate with testing
• Naive to PAP treatment
Locations
United States
Florida
University of Miami
RECRUITING
Miami
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Pennsylvania
The Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Time Frame
Start Date: 2021-03-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 86
Treatments
Active_comparator: Family-informed intervention (INT)
Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team.
Active_comparator: Standard Clinical Care
Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.
Related Therapeutic Areas
Sponsors
Collaborators: Children's Hospital Medical Center, Cincinnati, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania
Leads: University of Miami