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

Primary Purpose

Down Syndrome, Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open-ended semi-structured interviews
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Down Syndrome focused on measuring Down Syndrome, Obstructive Sleep Apnea

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Participants treated with PAP

Arm Description

This is a qualitative study for participants with Down Syndrome who use PAP to treat obstructive sleep apnea syndrome.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 4, 2019
Last Updated
April 4, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
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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1. Study Identification

Unique Protocol Identification Number
NCT04124471
Brief Title
Investigating the Experience of Living With Down Syndrome and Obstructive Sleep Apnea Syndrome (Stage 1)
Official Title
Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 1)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania, Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome, Obstructive Sleep Apnea
Keywords
Down Syndrome, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants treated with PAP
Arm Type
Other
Arm Description
This is a qualitative study for participants with Down Syndrome who use PAP to treat obstructive sleep apnea syndrome.
Intervention Type
Behavioral
Intervention Name(s)
Open-ended semi-structured interviews
Intervention Description
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 Measure Information:
Title
Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability
Description
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.
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Investigating the Experience of Living With Down Syndrome and Obstructive Sleep Apnea Syndrome (Stage 1)

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