Status:
RECRUITING
Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome
Lead Sponsor:
Children's Health Ireland
Collaborating Sponsors:
University of Edinburgh
Birmingham Children's Hospital
Conditions:
Obstructive Sleep Apnea
Down Syndrome
Eligibility:
All Genders
6-16 years
Brief Summary
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...
Detailed Description
Our aim is to examine the impact of non-invasive ventilation for treatment of obstructive sleep apnoea syndrome in children with Down Syndrome on behavioural and quality of life outcomes and to establ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 28 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06030349
Start Date
November 28 2022
End Date
December 28 2027
Last Update
February 12 2024
Active Locations (6)
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1
Trinity College Dublin
Dublin, Ireland, D02 PN40
2
Children's Health Ireland
Dublin, Ireland, D12 N512
3
Royal Belfast Hospital for Sick Children
Belfast, United Kingdom, BT12 6BA
4
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH