Down Syndrome, Obstructive Sleep Apnea
Conditions
Keywords
Down Syndrome, Obstructive Sleep Apnea, PAP, Positive Airway Pressure
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.
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.
Sponsors
University of Miami
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital Medical Center, Cincinnati
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
family-informed intervention (INT) vs standard clinical care (CON).
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Nights Adherent to PAP Therapy from Initiation to 6 Months | 6 months | PAP adherence will be assessed as the percentage of nights in which the participant is adherent to PAP therapy from initiation (T0) through 6 months (T6). This is calculated as the number of nights meeting adherence criteria divided by the total number of nights during the participant's study participation period, multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Minutes of PAP Use on Nights Used | 6 months | PAP adherence will be measured as the number of minutes of PAP use per night among nights with any recorded PAP use, calculated per participant from PAP initiation through the end of the 6-month intervention period. |
| Change in PedsQL Total Score (Quality of Life) | Baseline, 6 months, and 12 months | Quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL) total score. The PedsQL is a 5-point scale ranging from 0 to 4(0 = Never, 4 = Always), with higher scores indicating better quality of life. |
| Change in Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) Parent Report Score | Baseline, 6 months, and 12 months | Executive functioning will be assessed using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) Parent Report. Scores are reported as standardized T-scores, which range from 30 to 120. Lower T-scores indicate better executive functioning, while higher T-scores indicate greater executive dysfunction. |
| Percentage of Nights Adherent to PAP Therapy from Initiation to 12 Months | 12 months | PAP adherence will be assessed as the percentage of nights in which the participant is adherent to PAP therapy from initiation (T0) through 12 months (T12). This is calculated as the number of nights meeting adherence criteria divided by the total number of days during the participant's study participation period, multiplied by 100. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORIgnacio E. Tapia, M.D., M.S.
University of Miami
Outcome results
None listed