Clinical trial NCT04124471: 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
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Obstructive Sleep Apnea
Keywords: Down Syndrome
Obstructive Sleep Apnea
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Pennsylvania
name: Children's Hospital Medical Center, Cincinnati
First posted: 2019-10-11
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
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