Positive Airway Pressure (PAP) for Children With Down Syndrome (DS) and Obstructive Sleep Apnea Syndrome (OSAS)

NCT04132999 | Completed

• 3 other identifiers: 20230780R61HL151253R33HL151253
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 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.

Conditions

Down Syndrome; Obstructive Sleep Apnea

Keywords

Down Syndrome; Obstructive Sleep Apnea; PAP; Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• Percentage of Nights Adherent to PAP Therapy from Initiation to 6 Months

  PAP adherence will be assessed as the percentage of nights in which the participant is adherent to PAP therapy from initiation (T0) through 6 months (T6). This is calculated as the number of nights meeting adherence criteria divided by the total number of nights during the participant's study participation period, multiplied by 100.

  6 months

Secondary Outcomes (4)

• Number of Minutes of PAP Use on Nights Used

  6 months

• Change in PedsQL Total Score (Quality of Life)

  Baseline, 6 months, and 12 months

• Change in Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) Parent Report Score

  Baseline, 6 months, and 12 months

• Percentage of Nights Adherent to PAP Therapy from Initiation to 12 Months

  12 months

Study Arms (2)

Family-informed intervention (INT)

ACTIVE COMPARATOR

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

Behavioral: Family-informed intervention

Standard Clinical Care

ACTIVE COMPARATOR

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

Behavioral: Standard Clinical Care

Interventions

Family-informed intervention BEHAVIORAL

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

Family-informed intervention (INT)

Standard Clinical Care BEHAVIORAL

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

Standard Clinical Care

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical referral for PAP initiation to treat OSAS
• Ages 6-18 years
• Children are able to cooperate with testing
• Have not used PAP for the past 3 years prior to enrollment

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.

Sponsors & Collaborators

• University of Pennsylvania: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• University of Miami: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

University of Miami

Miami, Florida, 33136, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

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: 41285506 DERIVED

MeSH Terms

Conditions

Down Syndrome; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Ignacio E. Tapia, M.D., M.S.

  University of Miami

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: family-informed intervention (INT) vs standard clinical care (CON).

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 21, 2019
• Study Start: March 1, 2021
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 30, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)