RecruitingNot ApplicableNCT04132999

PAP for Children With DS and OSAS

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


Sponsor

University of Miami

Enrollment

86 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 18 Years

Inclusion Criteria4

  • Clinical referral for PAP initiation to treat OSAS
  • Ages 6-18 years
  • Children are able to cooperate with testing
  • Naive to PAP treatment

Exclusion Criteria5

  • 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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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.


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

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NCT04132999


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