Investigating the Experience of Living With Down Syndrome and Obstructive Sleep Apnea Syndrome (Stage 1)
NCT ID: NCT04124471
Last Updated: 2023-04-25
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
42 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-08-02
Study Completion Date
2022-08-01
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Down Syndrome
Obstructive Sleep Apnea
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Participants treated with PAP
This is a qualitative study for participants with Down Syndrome who use PAP to treat obstructive sleep apnea syndrome.
Group Type
OTHER
Open-ended semi-structured interviews
Intervention Type
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.
Interventions
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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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Children with DS and OSAS treated with PAP for at least 6 months
* Children aged between 6 and 17.5 years
* English proficiency
* Parent or legal guardian of an eligible patient subject
* English proficiency
* Must live with the patient subject at least 4 nights of the week
* Children aged between 6 and 17.5 years
* English proficiency
* 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
* 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
* Foster parent
* Diagnosed with major illness, such as leukemia or severe cyanotic congenital heart disease listed for cardiac transplant as these severe diseases may add confounders
* Foster parent
Minimum Eligible Age
6 Years
Maximum Eligible Age
17 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
University of Pennsylvania
OTHER
Sponsor Role
collaborator
Children's Hospital Medical Center, Cincinnati
OTHER
Sponsor Role
collaborator
Children's Hospital of Philadelphia
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Site Status
Countries
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United States
References
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Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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19-016222
Identifier Type: -
Identifier Source: org_study_id
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