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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Down Syndrome
• Interventions: Behavioral: Open-ended semi-structured interviews

• Registration Number: NCT04124471
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Study Timeline

• Study Start: 2019-08-02
• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Primary Completion: 2022-01-01
• Study Completion: 2022-08-01
• Results First Submitted: 2022-11-08
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Results First Posted: 2023-04-25
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants treated with PAP	Open-ended semi-structured interviews	This is a qualitative study for participants with Down Syndrome who use PAP to treat obstructive sleep apnea syndrome.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability	one day	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.

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States