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

Sponsor
Children's Health Ireland
Study ID
NCT06030349
Status
Recruiting
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Conditions

  • Adherence, Treatment
  • Behavior
  • Down Syndrome
  • Obstructive Sleep Apnea
  • Quality of Life

Eligibility Criteria

Sex
ALL
Age
6 Months - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • Non-invasive ventilation — DEVICE
    Non-invasive ventilation

Study Details

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.

Key Dates

First listed
Sep 11, 2023
Start date
Nov 28, 2022
Status verified
Feb 2024
Primary completion
Nov 28, 2027
Completion
Dec 28, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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. [ Time Frame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment ]

Central Contacts

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