Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-16
SponsorChildren's Health Ireland
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Non-invasive ventilation
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Children's Health Ireland
Lead sponsor
University of Edinburgh
Collaborator
Birmingham Children's Hospital
Collaborator
Belfast Health and Social Care Trust
Collaborator
University Hospital Southampton NHS Foundation Trust
Collaborator
University of Dublin, Trinity College
Collaborator
Source ClinicalTrials.gov