PAP for Children With DS and OSAS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 2)

Conditions
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Down Syndrome, Obstructive Sleep Apnea

Intervention / Treatment
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* Behavioral: Family-informed intervention
* Behavioral: Standard Clinical Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: family-informed intervention (INT) vs standard clinical care (CON).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Family-informed intervention (INT)<br>Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team. | Behavioral: Family-informed intervention<br>* Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team<br>|
| Active Comparator: Standard Clinical Care<br>Support which is given as part of the standard clinical care for patients who are currently prescribed PAP. | Behavioral: Standard Clinical Care<br>* Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of PAP adherence on quality of life and neurobehavioral outcomes | 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). | Baseline, 6 months, and 12 months | 
| Efficacy of INT-PAP in promoting PAP adherence | Adherence to PAP expressed as percentage of nights used, and minutes of usage on nights used. | 6 months, and 12 months | 
| Efficacy of CON in promoting PAP adherence | Adherence to PAP expressed as percentage of nights used, and minutes of usage on nights used. | 6 months, and 12 months | 
| 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 | 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. | Baseline, 6 months, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Down Syndrome, Obstructive Sleep Apnea, Positive Airway Pressure, PAP