Skip to main content
OpenTrials
Completed

NCT Number: NCT04124471

Investigating the Experience of Living With Down Syndrome and Obstructive Sleep Apnea Syndrome (Stage 1)

To identify the perceptions, beliefs, and family-relevant outcomes regarding the treatment of obstructive sleep apnea syndrome (OSAS) with positive airway pressure (PAP) in children with Down's Syndrome (DS).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

This is a multi-center outpatient study to be performed at two clinical sites: Children's Hospital of Philadelphia and Cincinnati Children's Hospital. Forty Caregivers of children with DS and OSAS treated with PAP and their children will be enrolled. The study comprises one 30-minute open-ended semi-structured interview per caregiver. The duration of the interview is approximate. It will last up to 30 minutes as some families may want to include more details.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-- Patients

  • Children with DS and OSAS treated with PAP for at least 6 months
  • Children aged between 6 and 17.5 years
  • English proficiency

Inclusion criteria

-- Caregivers

  • Parent or legal guardian of an eligible patient subject
  • English proficiency
  • Must live with the patient subject at least 4 nights of the week

Exclusion criteria

-- Patients

  • In foster care
  • Diagnosed with major illness, such as leukemia or severe cyanotic congenital heart disease listed for cardiac transplant as these severe diseases may add confounders

Exclusion criteria

-- Caregivers

  • Foster parent

Treatment and study plan

Open-ended semi-structured interviews

Behavioral

Semi-structured interviews will explore such key constructs as knowledge/belief about OSAS and PAP therapy, routines and resources that promote or limit PAP use, barriers, self-efficacy, and communication and attitudes about PAP. The interviews will be performed with the parent and that they will be audio-recorded.

Primary outcomes

  1. Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability

    Time frame: one day

    PAP feasibility will be measured by completion of semi-structured interviews to explore attitudes about PAP therapy in youth with Down Syndrome and Obstructive Sleep Apnea Syndrome.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

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

Registry information

Official study title

Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 1)

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 11, 2019
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.