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)
3 other identifiers
interventional
86
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2019
CompletedFirst Posted
Study publicly available on registry
October 21, 2019
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedAugust 12, 2025
August 1, 2025
4.8 years
October 10, 2019
August 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Effect of PAP adherence on quality of life and neurobehavioral outcomes
PedsQL score and measures of executive functioning will be compared in the 2 groups. PedsQL is a 5-point scale ranging from 0-4 (0 = Never, 4 = Always).
Baseline, 6 months, and 12 months
Efficacy of INT-PAP in promoting PAP adherence
Adherence to PAP expressed as percentage of nights used, and minutes of usage on nights used.
6 months, and 12 months
Efficacy of CON in promoting PAP adherence
Adherence to PAP expressed as percentage of nights used, and minutes of usage on nights used.
6 months, and 12 months
Effect of PAP adherence in children with DS and OSAS on patient-centered outcomes and family-relevant outcomes identified during the R61 phase of this research
Patient-centered outcomes and family-relevant outcomes - identified during the R61 phase of the study (Stage 1) - will be compared between the intervention and control groups. These are qualitative measures, and require interviews and further analysis to be established.
Baseline, 6 months, and 12 months
Study Arms (2)
Family-informed intervention (INT)
ACTIVE COMPARATORMultiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team.
Standard Clinical Care
ACTIVE COMPARATORSupport which is given as part of the standard clinical care for patients who are currently prescribed PAP.
Interventions
Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team
Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.
Eligibility Criteria
You may qualify if:
- Clinical referral for PAP initiation to treat OSAS
- Ages 6-18 years
- Children are able to cooperate with testing
- Naive to PAP treatment
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- National Institutes of Health (NIH)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
- University of Pennsylvaniacollaborator
Study Sites (3)
University of Miami
Miami, Florida, 33136, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Xanthopoulos MS, Byars K, Meinzen-Derr J, Ebensen A, Xiao R, Heubi C, Gurbani NS, Ishman SL, Bradford R, Hicks S, Redline S, Tapia IE. Standard medical care versus enhanced interdisciplinary care for implementation of positive airway pressure in youth with Down syndrome: a randomised controlled trial protocol. BMJ Open. 2025 Nov 23;15(11):e110990. doi: 10.1136/bmjopen-2025-110990.
PMID: 41285506DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2019
First Posted
October 21, 2019
Study Start
March 1, 2021
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
August 12, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share