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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04124471
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 16, 2019
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
The primary objective of this study is to identify the perceptions, beliefs, and family-relevant outcomes regarding the treatment of OSAS with PAP in children with DS.

Condition or disease Intervention/treatment Phase
Down Syndrome Obstructive Sleep Apnea Behavioral: Open-ended semi-structured interviews Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 1)
Actual Study Start Date : August 2, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Intervention Details:
  • Behavioral: Open-ended semi-structured interviews
    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 Outcome Measures :
  1. PAP Acceptability [ Time Frame: one day ]
    Perform qualitative interviews to determine factors that impact PAP acceptability and use in youth with DS and OSAS, and identify family-centered outcomes to inform the development of an intervention to improve adherence to CPAP

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04124471

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Contact: Ignacio E Tapia, MD (267) 426-5842
Contact: Ruth Bradford (267) 246-5747

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United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ignacio E Tapia, MD    267-426-5842   
Contact: Mary Pipan, MD    (267) 426-5200   
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital of Philadelphia Identifier: NCT04124471     History of Changes
Other Study ID Numbers: 19-016222
R61HL151253-01 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
Down Syndrome
Obstructive Sleep Apnea
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Down Syndrome
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn