Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome
Recruiting now
Conditions studied: Obstructive Sleep Apnea, Down Syndrome, Quality of Life, Behavior, Adherence, Treatment
In brief
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.
Key facts
- Study ID
- NCT06030349
- Run by
- Children's Health Ireland
- People needed
- 200
- Starts
- 2022-11-28
- Expected to finish
- 2027-12-28
- Last updated by the study team
- 2024-02-12
Who can join
Age: 1 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Trinity College Dublin — Dublin, Ireland (enrolling)
- Children's Health Ireland — Dublin, Ireland (enrolling)
- 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
Full record on ClinicalTrials.gov
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