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RECRUITING
NCT06030349

Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome

Sponsor: Children's Health Ireland

View on ClinicalTrials.gov

Summary

The goal of this observational study is to learn about the use of non-invasive ventilation for treatment of obstructive sleep apnoea syndrome in children with Down Syndrome. The main questions it aims to answer are: * What is the impact of non-invasive ventilation on sleep behaviours and quality of life? * What barriers are faced by children and their families in establishing tolerance to non-invasive ventilation? Participants will be asked to complete questionnaires before and after starting treatment. Researchers will compare this data with the results of sleep studies and non-invasive ventilator downloads recorded as part of standard medical care. A sub-group of up to 20 participants will be invited to take part in 45-60 minute interviews exploring expectations, experiences and barriers encountered during non-invasive ventilation therapy.

Official title: Real World Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea Syndrome in Children With Down Syndrome

Key Details

Gender

All

Age Range

6 Months - 16 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2022-11-28

Completion Date

2027-12-28

Last Updated

2024-02-12

Healthy Volunteers

No

Interventions

DEVICE

Non-invasive ventilation

Non-invasive ventilation

Locations (6)

Trinity College Dublin

Dublin, Ireland

Children's Health Ireland

Dublin, Ireland

Royal Belfast Hospital for Sick Children

Belfast, United Kingdom

Birmingham Children's Hospital

Birmingham, United Kingdom

Royal Hospital for Children & Young People

Edinburgh, United Kingdom

Southampton Children's Hospital

Southampton, United Kingdom