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

Recruitingn/aAges 6 Months - 16 YearsAllChildren's Health Ireland
NCT06030349 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Individuals with a confirmed diagnosis of Down Syndrome where a clinical decision has been made to initiate respiratory support with non-invasive ventilation. * Obstructive Apnoea Hypopnoea Index \> 2 episodes/hour or where sleep disordered breathing symptoms occur in combination with an Apnoea Hypopnoea Index \> 1 episode/hr. - English language proficiency. * Age ≥ 4 months at the commencement of therapy. Exclusion Criteria: * Individuals not willing to comply with study procedures or assessments. * Individuals for whom ventilatory support devices are already prescribed and those with artificial airways. * Individuals on clinical trials of investigational support therapies.
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What it tests

  • Non-invasive ventilation
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Where

6 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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