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

Study Overview
=================
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.

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

Conditions
-----------------
Down Syndrome, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Behavioral: Open-ended semi-structured interviews


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants treated with PAP<br>This is a qualitative study for participants with Down Syndrome who use PAP to treat obstructive sleep apnea syndrome. | Behavioral: Open-ended semi-structured interviews<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Down Syndrome, Obstructive Sleep Apnea