Actively Recruiting
Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome
Led by Children's Health Ireland · Updated on 2024-02-12
200
Participants Needed
6
Research Sites
265 weeks
Total Duration
On this page
Sponsors
C
Children's Health Ireland
Lead Sponsor
U
University of Edinburgh
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals with confirmed Down Syndrome where a decision has been made to start non-invasive ventilation.
- Obstructive Apnoea Hypopnoea Index greater than 2 episodes/hour or symptoms combined with an index over 1 episode/hour.
- English language proficiency.
- Age 4 months or older when starting therapy.
You will not qualify if you...
- Individuals unwilling to follow study procedures or assessments.
- Individuals already using ventilatory support devices or with artificial airways.
- Individuals participating in clinical trials of investigational support therapies.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Trinity College Dublin
Dublin, Ireland, D02 PN40
Actively Recruiting
2
Children's Health Ireland
Dublin, Ireland, D12 N512
Actively Recruiting
3
Royal Belfast Hospital for Sick Children
Belfast, United Kingdom, BT12 6BA
Not Yet Recruiting
4
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Not Yet Recruiting
5
Royal Hospital for Children & Young People
Edinburgh, United Kingdom, EH16 4TJ
Not Yet Recruiting
6
Southampton Children's Hospital
Southampton, United Kingdom, SO16 6YD
Not Yet Recruiting
Research Team
R
Roy G Stone
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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