Actively Recruiting

Phase Not Applicable
Age: 6Years - 18Years
All Genders
NCT04132999

PAP for Children With DS and OSAS

Led by University of Miami · Updated on 2025-08-12

86

Participants Needed

3

Research Sites

252 weeks

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PAP for Children With DS and OSAS

Who Can Participate

Age: 6Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical referral for PAP initiation to treat OSAS
  • Ages 6-18 years
  • Children are able to cooperate with testing
  • Naive to PAP treatment
Not Eligible

You will not qualify if you...

  • 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 previously treated with PAP
  • Caregivers who do not speak English well enough to complete behavioral and performance measures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 3 locations

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

2

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

3

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here