RecruitingInterventional

A feasibility randomised controlled trial of a novel postural management night-time intervention to improve respiratory health of children with complex neurodisability (ADAPT)

The ADAPT study is exploring a new overnight sleeping position called Breathe-Easy for children with complex neurological conditions. These children often have chest infections because food or liquid can accidentally enter their lungs when lying on their backs. Breathe-Easy suggests lying partway on their front to help drain fluids. This study aims to find out if parents can safely use Breathe-Easy at home, if families are willing to take part in such a study, and if the tools we use to measure health and well-being are suitable. The goal is to see if Breathe-Easy could improve breathing and sleep for these children, and whether we can run a larger trial in the future to prove it works.

At a glance

Status

Recruiting

Sponsor

Sussex Community NHS Foundation Trust

Enrolment target

150

Start

01 Nov 2025

Estimated completion

31 Dec 2026

Neurological and respiratory, other diseases of the respiratory system, other disorders of the nervous system

What is this study about?

The ADAPT study is looking into a new way to help children with complex health needs, specifically those with nerve and breathing problems. These children often get sick with chest infections, which can lead to many hospital visits and are a serious concern. One common reason for these infections is when things like spit, food, or drink accidentally go down the wrong way into their lungs, especially when they're lying down. Currently, some advice suggests children lie on their backs to help with their body's position, but this can actually increase the risk of things going into their lungs.

Our team has developed a new approach called Breathe-Easy. This involves children sleeping partly on their front, which we believe could help drain fluids from their mouth and reduce the risk of chest infections. This study is the first step, designed to check if Breathe-Easy can be safely used by parents at home, if our instructions are easy to follow, and if families are happy to be part of this type of research. We also want to make sure we're asking the right questions to measure how well children are doing.

The main goal of this study is not to prove that Breathe-Easy works perfectly yet. Instead, it's to gather important information that will help us plan a bigger study in the future. That larger study would then definitively check if Breathe-Easy genuinely improves children's breathing and overall health in the long term.

Key takeaways

ADAPT tests a new sleeping position (Breathe-Easy) for children with complex needs.
It aims to improve breathing and reduce chest infections at night.
The study wants to check if Breathe-Easy is safe and easy for parents to use.
Children aged 2-18 with swallowing difficulties and feeding tubes may be eligible.
Participants will be in the study for six months, with regular checks.
This is a first step to see if a larger study on Breathe-Easy is possible.

Who may be eligible?

This study is looking for around 50 children aged between 2 and 18 years old. To be able to take part, a child must need help from others to move or change their position. They should also have difficulties with swallowing, which puts them at a high risk of food or liquid entering their lungs.

Additionally, children must be fed through a special tube called a gastrostomy or jejunostomy, and they should have had at least one chest infection needing antibiotics in the last year. This helps us ensure the study focuses on children who are most likely to benefit from this type of intervention.

However, some children won't be able to join. For example, if they use a feeding tube through their nose, or if their gastrostomy feeds cannot be changed to daytime only (jejunostomy feeds are still okay). Children who are about to move into adult care, or who have planned surgery on their bones during the study period, also won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 2 and 18 years?
Does your child need help from others to move or change their body position?
Does your child have trouble swallowing, putting them at high risk of food or liquid entering their lungs?
Is your child fed using a gastrostomy or jejunostomy tube?
Has your child had a chest infection needing antibiotics in the last year?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will be randomly assigned to one of two groups for six months. One group will try the new Breathe-Easy sleeping position, while the other will continue with their usual night-time sleeping position. Your child will not be able to choose which group they are in, as this helps make the study fair.

Throughout the six months, we will collect information at the very beginning of the study, then after three months, and again at six months. This will involve filling out questionnaires about your child's breathing, sleep, pain, and how they feel generally. We will also look at medical records for information about their use of antibiotics, X-rays, and any hospital stays for chest infections. We will also ask children (if able), parents, and healthcare staff to share their experiences of taking part in the study through surveys.

Potential risks and benefits

Taking part in this study could offer some potential benefits. The new Breathe-Easy sleeping position might help improve your child's breathing during the night and possibly lead to better sleep for them. Even if your child is in the usual care group, both groups are likely to receive closer attention and monitoring than typical community care, which can be reassuring. However, this new sleeping position might not suit every child's individual needs. It could potentially impact your child's sleep, or even yours as a parent, and might change your usual night-time routines. You are free to withdraw from the study at any time, for any reason, without it affecting your child's usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Alder Hey Children's NHS Foundation Trust
City only
Liverpool, England
Sussex Community NHS Foundation Trust
City only
Brighton, England
Guy's and St Thomas' NHS Foundation Trust
City only
London, England
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle upon Tyne, England

Common questions

What is the Breathe-Easy position?

It's a special sleeping position where a child lies partly on their front, designed to help drain fluids from their mouth and reduce the risk of chest infections overnight.

Will my child automatically receive the Breathe-Easy position?

No, your child will be randomly put into either the Breathe-Easy group or the group that continues with usual night-time sleeping positions. You won't be able to choose.

How long does the study last?

If your child participates, they will be part of the study for six months.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

What if we change our mind about participating?

You are free to withdraw your child from the study at any time, for any reason, and it will not affect their normal medical care.

How to find out more

Sarah Crombie

sarah.crombie@nhs.net - Official trial record

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