NCT04124471

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Down Syndrome
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2019-08-02
• Primary completion: 2022-01-01
• Completion: 2022-08-01
• First posted: 2019-10-11
• Last updated: 2023-04-25
• Results posted: 2023-04-25

Locations

1 site across 1 country: United States