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N-WATCH: Nottingham Wheeze Assessment in Tidal Children

The N-WATCH study is exploring a new device called N-Tidal C for children aged 5-15 who have breathing difficulties like asthma. Often, current tools for checking lung health in children are expensive, too big, or hard for them to use. This new, small device measures carbon dioxide levels when a child breathes normally, which could show how their lungs are working. The researchers want to find out how well the N-Tidal C device compares to standard lung tests and how many children would need to take part in a bigger study in the future. The goal is to see if this easy-to-use device can help families manage long-term lung conditions better, allowing them to spot problems sooner and get help quickly.

At a glance

Status
Recruiting
Sponsor
University of Nottingham
Enrolment target
340
Start
15 Jul 2024
Estimated completion
31 Dec 2026

What is this study about?

Children who have long-term lung conditions, like asthma, often need good ways to find out what’s wrong and to keep an eye on their health. If they have better tools to monitor their condition, it can help both the children and their parents manage their breathing problems more effectively. This could mean spotting when their condition is getting worse earlier, like before an asthma attack, so they can get help sooner.

However, many of the current devices that could be used at home are either too expensive, too large, or need children to breathe in specific ways that are difficult for younger children or that patients don't like. This means there's a real need for better and simpler devices.

This study is looking at a new medical device called the N-Tidal C. It's a small device that measures the amount of carbon dioxide a child breathes out. What's special about it is that it's easy to use and doesn't require any special breathing – children just breathe normally into it. Early tests in adults with lung problems like COPD suggest it can pick up changes in how the lungs are working. The researchers want to find out if this device could be useful for children by seeing how well its measurements match up with standard lung tests.

Key takeaways

  • This study is testing a new, simple device for children with breathing problems.
  • The device, N-Tidal C, measures breathed-out carbon dioxide and is easy to use.
  • It aims to find better ways to monitor children's lung health, especially for conditions like asthma.
  • Children aged 5-15 are needed for a single visit to the hospital.
  • No medication is involved, and it’s a low-risk study.
  • Results will help plan bigger studies for the future.

Who may be eligible?

The N-WATCH study is looking for children aged between 5 and 15 years old. This means children who are at least 5 years old but not yet 16.

There are two main groups of children they are looking for:

* **Group 1:** Children who have recently come to the hospital because they had wheezing, breathing problems (like bronchospasm), or asthma. They must not be seriously unwell and need to be able to breathe into a small mouthpiece for about 90 seconds.

* **Group 2:** Children who are already scheduled to have their usual lung function tests at the hospital.

Children cannot take part if they are very seriously unwell with breathing difficulties (for example, if their lips are blue, their oxygen levels are very low even with extra oxygen, or they are very tired). They also can't join if they are already in another research study that prevents them from taking part in this one.

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.

  1. Is my child between 5 and 15 years old (not yet 16)?
  2. Has my child recently been to hospital for wheezing or asthma problems?
  3. Is my child able to breathe into a mouthpiece for about 90 seconds?
  4. Is my child due to have routine lung function tests soon?
  5. Is my child not seriously unwell with their breathing right now?
  6. Is my child not currently in another research study that would stop them from joining this one?
Answer every question to see your result.

What does participation involve?

If you or your child decide to take part in this study, the child will need to visit the hospital. During this visit, they will breathe normally into the N-Tidal C device for about 90 seconds. If they are in the group already having routine lung tests, these standard tests will also be carried out as planned. There are no medications involved in this study. The total duration of participation is typically just one visit, and there is no long-term follow-up required after that visit.

Potential risks and benefits

The main benefit of taking part is helping researchers understand if this new, easy-to-use device could improve how we monitor children's lung health in the future. This could lead to better management of conditions like asthma. There are no major risks, as the device just measures breathing and doesn't involve medication or invasive procedures; the main discomfort might be breathing into a mouthpiece for a short time. You are free to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (2)

  • Nottingham University Hospitals NHS Trust
    Verified postcode
    Nottingham, United Kingdom· Recruiting
  • Nottingham University Hospitals NHS Trust
    Verified postcode
    Nottingham, United Kingdom· Recruiting

Common questions

What is the N-Tidal C device?

It's a small device that measures how much carbon dioxide your child breathes out, which can show how their lungs are working.

Is the device safe for my child?

Yes, it's a CE Marked medical device, meaning it meets European safety standards. It's non-invasive and just involves normal breathing.

Will my child need to take any medicine for this study?

No, this study does not involve any medication. It's only about using the N-Tidal C device and, for some, having standard lung tests.

How long does taking part in the study take?

Participation usually involves a single visit to the hospital, lasting a short time while the measurements are taken.

Will I get results from my child's test?

The study aims to gather information for future research. While individual results won't be used for your child's immediate care, you can discuss any concerns with your doctor.

How to find out more

Andrew P Prayle, BMBS

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

Interested in taking part?

Register your interest

Share your details and the research team for "N-WATCH: Nottingham Wheeze Assessment in Tidal Children…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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