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

This study aims to understand how a breathing machine, called non-invasive ventilation, helps children with Down Syndrome who have a sleep condition called obstructive sleep apnoea. Researchers want to see if this treatment improves their sleep, daily behaviour, and overall quality of life. The study also explores the difficulties children and their families might encounter when getting used to and using the machine regularly. They'll use questionnaires, sleep study results, and information from the breathing machines, which are all part of standard care. Some families will also be invited to talk about their experiences in interviews, helping researchers gather valuable insights into making the treatment easier to manage.

At a glance

Status

Recruiting

Sponsor

Children's Health Ireland

Enrolment target

200

Start

28 Nov 2022

Estimated completion

28 Dec 2027

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

What is this study about?

This research is looking into how a special breathing machine, called non-invasive ventilation, helps children with Down Syndrome who also have a condition called obstructive sleep apnoea. Sleep apnoea means that a child's breathing repeatedly stops and starts during sleep. This can lead to restless nights, daytime sleepiness, and sometimes affect their behaviour and how they feel overall. When a child has both Down Syndrome and sleep apnoea, managing their breathing can be especially important.

The main goal of this study is to understand two key things. Firstly, how does using this breathing machine affect the child's daily actions, feelings, and general well-being? Researchers want to see if it makes a positive difference to their quality of life. Secondly, they want to find out what problems or challenges children and their families might face when starting and regularly using the non-invasive ventilation machine. Understanding these difficulties is really important so that support can be improved for other families in the future.

To gather this information, the researchers will use questionnaires that families complete before and after the child starts treatment. They will also look at information from the child's sleep studies and the breathing machine itself, which are done as part of their usual medical care. Additionally, a smaller group of families will be invited to have a private chat with the researchers to share their expectations, experiences, and any problems they've come across while using the breathing machine. All this information will help doctors understand how to best support children with Down Syndrome and sleep apnoea.

Key takeaways

Focuses on children with Down Syndrome and sleep apnoea.
Examines effects of breathing support machines (non-invasive ventilation).
Aims to understand well-being, behaviour, and daily challenges.
Involves questionnaires and reviewing medical records.
A small number of families may be interviewed.
No changes to your child's medical treatment in the study.

Who may be eligible?

This study is looking for children who have both Down Syndrome and have been diagnosed with obstructive sleep apnoea. A doctor must have already decided that non-invasive ventilation, which is a breathing support machine, is the right treatment for their sleep apnoea.

To be included, the child must be at least 4 months old when they start this breathing treatment. Their sleep study results should show a certain level of breathing problems during sleep, or they should have symptoms of disturbed breathing along with milder sleep study results. It's also important that the families speak English, as questionnaires and interviews will be in English.

Children cannot join the study if they are unwilling to follow the study steps, are already using similar breathing support machines, or are involved in another study testing new support treatments. Also, children who have tubes to help them breathe (like a tracheostomy) cannot take part.

Quick self-check

Does your child have Down Syndrome and obstructive sleep apnoea?
Has a doctor decided your child needs a non-invasive ventilation machine?
Is your child at least 4 months old when starting this treatment?
Do you and your family speak English?
Are you willing to share your experiences through questionnaires?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part in this study, you will be asked to complete some questionnaires. These questionnaires will ask about your child's sleep, behaviour, and overall well-being. You will fill them in before your child starts using the non-invasive ventilation machine and again after they have been using it for a while. The researchers will also use information from your child's usual medical care, such as results from their sleep studies and data from their breathing machine. For a small number of families (up to 20), there will be an invitation to take part in an interview lasting about 45 to 60 minutes. This interview will be a chance to talk about your expectations, experiences, and any challenges you've faced with the breathing treatment. There are no extra visits specifically for this study; all assessments mentioned are part of standard care or can be done at home.

Potential risks and benefits

Participating in this study might offer a chance for your experiences with the breathing machine to help other families in the future, as the study aims to improve support for children with Down Syndrome and sleep apnoea. There are no medical risks directly associated with being part of this study itself, as it mainly involves answering questionnaires and sharing experiences, and your child's medical care and treatment decisions will continue as normal. You are free to withdraw from the study at any time without giving a reason, and this will not affect your child's medical care in any way.

Locations (6)

Trinity College Dublin
Dublin, Ireland· Recruiting
Children's Health Ireland
Dublin, Ireland· Recruiting
Royal Belfast Hospital for Sick Children
Belfast, United Kingdom· Not yet recruiting
Birmingham Children's Hospital
Birmingham, United Kingdom· Not yet recruiting
Royal Hospital for Children & Young People
Edinburgh, United Kingdom· Not yet recruiting
Southampton Children's Hospital
Southampton, United Kingdom· Not yet recruiting

Common questions

What is 'non-invasive ventilation'?

It's a type of breathing machine that helps people breathe more easily while they sleep, without needing surgery.

What is 'obstructive sleep apnoea'?

It's a condition where a child's breathing repeatedly stops and starts during sleep, leading to lighter sleep and sometimes daytime tiredness.

Do we have to visit a special clinic for this study?

No, the study mostly uses information from your child's regular medical checks and involves questionnaires you can complete.

Will my child get a different treatment if we join?

No, your child will receive the same standard medical care and treatment as decided by their doctors; this study just observes the effects.

How long will our participation last?

You will complete questionnaires before and after starting treatment. If invited, the interview would be a single 45-60 minute session.

How to find out more

Roy G Stone

refreshed@olchc.ie 0035314282626 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.