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RECRUITINGOBSERVATIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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