Positive Airway Pressure (PAP) for Children With Down Syndrome (DS) and Obstructive Sleep Apnea Syndrome (OSAS)

University of Miami27 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Down Syndrome Obstructive Sleep Apnea

Interventions

Family-informed interventionBEHAVIORAL

Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team

Standard Clinical CareBEHAVIORAL

Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Percentage of Nights Adherent to PAP Therapy from Initiation to 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.

Time frame: 6 months

Secondary Outcomes

Number of Minutes of PAP Use on Nights Used

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.

Time frame: 6 months

Change in PedsQL Total Score (Quality of Life)

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.

Time frame: Baseline, 6 months, and 12 months

Change in Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) Parent Report Score

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.

Time frame: Baseline, 6 months, and 12 months

Percentage of Nights Adherent to PAP Therapy from Initiation to 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.

Data from ClinicalTrials.gov

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