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PAP for Children With DS and OSAS

NCT04132999 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-08-12

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Family-informed intervention

Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team

BEHAVIORAL

Standard Clinical Care

Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • University of Miami

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2026-01-01
Completion
2026-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04132999 on ClinicalTrials.gov