PAP for Children With DS and OSAS

Not Applicable

Recruiting

• Conditions: Down Syndrome; Obstructive Sleep Apnea
• Interventions: Behavioral: Family-informed intervention; Behavioral: Standard Clinical Care

• Registration Number: NCT04132999
• Lead Sponsor: University of Miami

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-21
• Study Start: 2021-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family-informed intervention (INT)	Family-informed intervention	Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team.
Standard Clinical Care	Standard Clinical Care	Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.

Primary Outcome Measures

Name	Time	Method
Efficacy of INT-PAP in promoting PAP adherence	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	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	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	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.

Trial Locations

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