Actively Recruiting
Real World Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea Syndrome in Children With Down Syndrome
Led by Children's Health Ireland · Updated on 2024-02-12
200
Participants Needed
6
Research Sites
4 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
Researchers are studying the effects of non-invasive ventilation on children with Down Syndrome who have obstructive sleep apnea syndrome. The study aims to understand how this treatment impacts sleep behaviors and quality of life, as well as to identify challenges children and their families face when adapting to the therapy. This observational research combines clinical data with patient-reported experiences to provide a comprehensive view of treatment outcomes. Participants will undergo standard clinical assessments, sleep studies, and ventilator data collection as part of their usual care. Alongside this, they will complete questionnaires tailored to their age group to evaluate behavior, quality of life, and barriers to treatment tolerance. A smaller group of up to 20 participants will also take part in in-depth interviews to explore their experiences and challenges in more detail. During the study, children aged 3 years and older will complete specific sleep and quality of life questionnaires before and after 8 weeks of non-invasive ventilation treatment, while younger children will complete age-appropriate assessments. Researchers will analyze changes in sleep behavior, caregiver concerns, and treatment adherence barriers. The study will last through the treatment initiation period, with data collected to assess the overall impact on quality of life and sleep in these children.
CONDITIONS
Brief 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 a confirmed diagnosis of Down Syndrome where a clinical decision has been made to start non-invasive ventilation.
- Obstructive Apnoea Hypopnoea Index greater than 2 episodes per hour or sleep disordered breathing symptoms with an index greater than 1 episode per hour.
- English language proficiency.
- Age 4 months or older at the start of therapy.
You will not qualify if you...
- Individuals unwilling to comply with study procedures or assessments.
- Individuals already prescribed ventilatory support devices or with artificial airways.
- Individuals currently participating in clinical trials of investigational support therapies.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks attempted initiation
Participants start treatment with non-invasive ventilation as part of their routine clinical care for obstructive sleep apnoea syndrome.
Visits as per standard care and device monitoring
Duration - After 8 weeks of attempted initiation
Participants complete questionnaire assessments evaluating behaviour, quality of life, and barriers to treatment adherence before and after the 8 weeks of treatment. A sub-group may participate in interviews exploring experiences and barriers.
1 follow-up visit with questionnaires; up to 20 participants invited for 45-60 minute interviews
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
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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