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Search / Trial NCT04132999

PAP for Children With DS and OSAS

Launched by UNIVERSITY OF MIAMI · Oct 17, 2019

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Down Syndrome Obstructive Sleep Apnea Pap Positive Airway Pressure

ClinConnect Summary

This clinical trial is studying how well a family-informed approach to treatment works for children with Down Syndrome who also have obstructive sleep apnea (OSAS). Obstructive sleep apnea is a condition where breathing is repeatedly interrupted during sleep, which can cause various health issues. The trial will compare this family-informed treatment to the standard care that is usually provided over a period of twelve months.

To participate in this study, children must be aged between 6 and 18 years, be newly diagnosed with OSAS, and be able to cooperate during testing. Unfortunately, some children may not be eligible if they have serious health issues, are planning to move away soon, or have previously used a specific treatment called PAP (Positive Airway Pressure). If they join the trial, participants can expect regular check-ins and support as they learn about managing their condition with the help of their families. This study is currently looking for participants, and it aims to provide valuable insights into the best ways to help children cope with sleep apnea.

Gender

ALL

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.

About University Of Miami

The University of Miami, a leading academic institution, is dedicated to advancing medical research and improving patient care through innovative clinical trials. With a commitment to excellence in education and research, the university fosters collaboration among multidisciplinary teams to explore new therapies and treatment modalities. Its extensive clinical programs are supported by state-of-the-art facilities and a diverse patient population, enabling the exploration of cutting-edge solutions to complex health challenges. The University of Miami is poised to contribute significantly to the field of medicine through its rigorous scientific inquiry and a steadfast commitment to ethical research practices.

Locations

Cincinnati, Ohio, United States

Miami, Florida, United States

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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