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
This trial does not accept healthy volunteersQualifiers
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 population
Children with Down Syndrome referred for evaluation for suspected sleep disordered breathing
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-invasive ventilation
DeviceNon-invasive ventilation
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Standard1 intervention
Group B: Advanced1 intervention
Trial outcomes
Primary outcomes
1
To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on quality of life in children with Down Syndrome > 3 years.
Change in Obstructive Sleep Apnoea - 18 scores (Range 0- 126, Higher scores indicating worse quality of life) from baseline will be used to evaluate for improvement in sleep related breathing specific quality of life in children \>3 years. Sleep disturbance, physical suffering, emotional distress, daytime problems and caregiver concern subscales will also be evaluated for change.
Time frame
Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment2
To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on quality of life in children with Down Syndrome < 3 years.
Change in Infant Toddler Quality of Life - Short Form 47 scores (Range 0 - 100, Higher scores indicating greater quality of life) from baseline will be used to evaluate for improvement in sleep related breathing specific quality of life in children \< 3 years. Infant and parent subscales will also be evaluated for change.
Time frame
Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment3
To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on caregiver concerns regarding sleep disordered breathing for caregivers of children with Down Syndrome < 3 years.
Change in Caregiver-concern domain of the Obstructive Sleep Apnoea - 18 (Range 0 - 28, Higher scores indicating worse quality of life) from baseline will be used to evaluate for change in caregiver concern regarding sleep disordered breathing.
Time frame
Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment4
To determine the effect of treatment of obstructive sleep apnoea with non-invasive ventilation on sleep behaviours in children with Down Syndrome > 3 years.
Change in Child Sleep Habits Questionnaire scores (Range 0 - 97, Higher scores indicating greater sleeping difficulties) from baseline will be used to evaluate for overall improvement in sleep behaviours in children \> 3 years. Bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night waking, parasomnia, sleep disordered breathing and daytime sleepiness subscales will also be evaluated for change.
Time frame
Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
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