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RecruitingNCT04132999

PAP for Children With DS and OSAS

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Trial Parameters

ConditionDown Syndrome
SponsorUniversity of Miami
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment86
SexALL
Min Age6 Years
Max Age18 Years
Start Date2021-03-01
Completion2026-01-01
Interventions
Family-informed interventionStandard Clinical Care

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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.

Eligibility Criteria

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.

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