Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome
NCT ID: NCT06030349
Last Updated: 2024-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2022-11-28
2027-12-28
Brief Summary
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* 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.
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Detailed Description
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Information from clinical assessment, sleep studies and device downloads recorded as part of standard care will be combined with questionnaire data to assess for changes in behaviour and quality of life. All participants will undergo questionnaire assessment of barriers experienced. A sub-group of up to 20 participants will be invited to take part in 45-60 minute semi-structured interviews exploring expectations, experiences and barriers encountered.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard
In addition to data from clinical assessment, sleep studies and non-invasive ventilator downloads recorded as part of standard care participants will undergo questionnaire assessment of behaviour, quality of life and barriers to tolerating treatment. Participants aged 3 years and above will receive the Child Sleep Habits Questionnaire, Obstructive Sleep Apnoea-18 questionnaire and Adherence Barriers to CPAP (Continuous Positive Airway Pressure) Questionnaire. Participants aged 6 months to 3 years will receive the Brief Infant Sleep Questionnaire, Infant Toddler Quality of Life - Short Form 47, Obstructive Sleep Apnoea -18 Caregiver Concern Domain and a modified version of the Adherence Barriers to CPAP Questionnaire.
Non-invasive ventilation
Non-invasive ventilation
Advanced
In addition to all elements of the standard testing group, a sub-group of up to 20 participants will be invited to take part in 45-60 minute semi-structured interviews exploring expectations, experiences and barriers encountered.
Non-invasive ventilation
Non-invasive ventilation
Interventions
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Non-invasive ventilation
Non-invasive ventilation
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Individuals for whom ventilatory support devices are already prescribed and those with artificial airways.
* Individuals on clinical trials of investigational support therapies.
6 Months
16 Years
ALL
No
Sponsors
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University of Edinburgh
OTHER
Birmingham Children's Hospital
OTHER
Belfast Health and Social Care Trust
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
University of Dublin, Trinity College
OTHER
Children's Health Ireland
OTHER_GOV
Responsible Party
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Sheila Javadpour
Clinical Lead for Respiratory Sleep Medicine
Principal Investigators
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Sheila Javadpour
Role: PRINCIPAL_INVESTIGATOR
Children's Health Ireland
Locations
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Trinity College Dublin
Dublin, , Ireland
Children's Health Ireland
Dublin, , Ireland
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
Countries
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Central Contacts
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Facility Contacts
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Ruth Monaghan
Role: primary
Dara O'Donoghue
Role: primary
Priti Kenia
Role: primary
Florian Gahleitner
Role: primary
Hazel Evans
Role: primary
Catherine M Hill
Role: backup
Other Identifiers
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REC137-22
Identifier Type: -
Identifier Source: org_study_id
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