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

Children's Hospital of Philadelphia42 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Down Syndrome Obstructive Sleep Apnea

Interventions

Open-ended semi-structured interviewsBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: one day

Data from ClinicalTrials.gov

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