Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 2)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 27
- Locations
- 6
- Primary Endpoint
- Efficacy of INT-PAP in promoting PAP adherence
Study Overview
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 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 better patient-centered outcomes, and family-relevant outcomes identified during the first year of this research.
Determine the efficacy of INT vs. CON in promoting PAP adherence. It is being hypothesized that that children receiving INT will show significantly increased objectively-measured PAP adherence at 6 months compared with those receiving CON (Aim 4A). As a secondary aim (4B), it will be evaluated whether the improved adherence is maintained over 12 months. It is being hypothesized that participants initially randomized to the INT arm will have better adherence at 12 months compared to those in the CON arm.
Use mixed methods during the randomized controlled trial to identify family perceptions, such as empowerment and self-efficacy, regarding PAP use in youth with OSAS and DS. It is being hypothesized that INT-PAP will be associated with more positive perceptions compared to CON.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Family-informed intervention (INT)
Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team.
Intervention: Family-informed intervention (Behavioral)
Standard Clinical Care
Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.
Intervention: Standard Clinical Care (Behavioral)
Outcomes
Primary Outcomes
Efficacy of INT-PAP in promoting PAP adherence
Time Frame: 6 months, and 12 months
Adherence to PAP expressed as percentage of nights used, and minutes of usage on nights used.
Efficacy of CON in promoting PAP adherence
Time Frame: 6 months, and 12 months
Adherence to PAP expressed as percentage of nights used, and minutes of usage on nights used.
Effect of PAP adherence on quality of life and neurobehavioral outcomes
Time Frame: Baseline, 6 months, and 12 months
PedsQL score and measures of executive functioning will be compared in the 2 groups. PedsQL is a 5-point scale ranging from 0-4 (0 = Never, 4 = Always).
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
Time Frame: Baseline, 6 months, and 12 months
Patient-centered outcomes and family-relevant outcomes - identified during the R61 phase of the study (Stage 1) - will be compared between the intervention and control groups. These are qualitative measures, and require interviews and further analysis to be established.
Secondary Outcomes
- Change in Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) Parent Report Score(Baseline, 6 months, and 12 months)
Investigators
Ignacio Tapia
Associate Professor of Pediatrics
University of Miami