Real World Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea Syndrome in Children With Down Syndrome

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Observational
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 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
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Ireland
Children's Health Ireland
RECRUITING
Dublin
Trinity College Dublin
RECRUITING
Dublin
United Kingdom
Royal Belfast Hospital for Sick Children
NOT_YET_RECRUITING
Belfast
Birmingham Children's Hospital
NOT_YET_RECRUITING
Birmingham
Royal Hospital for Children & Young People
NOT_YET_RECRUITING
Edinburgh
Southampton Children's Hospital
NOT_YET_RECRUITING
Southampton
Contact Information
Primary
Roy G Stone
refreshed@olchc.ie
0035314282626
Time Frame
Start Date: 2022-11-28
Estimated Completion Date: 2027-12-28
Participants
Target number of participants: 200
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Dublin, Trinity College, University Hospital Southampton NHS Foundation Trust, Belfast Health and Social Care Trust, Birmingham Children's Hospital, University of Edinburgh
Leads: Children's Health Ireland

This content was sourced from clinicaltrials.gov