Active not recruitingNAINTERVENTIONAL

NIV Mask and Headgear Evaluation

This study is looking at new, custom-made masks and headgear for children and young people who need breathing support through a mask, called Non-Invasive Ventilation (NIV). Standard masks often don't fit well, especially for children with different face shapes, leading to problems like discomfort or the treatment not working properly. We’ve developed a special mask and headgear using 3D technology. We want to see if our new system offers a better fit and comfort compared to their current mask. This work is really important because a well-fitting mask can significantly improve a child's quality of life and health, helping them get the most from their breathing support.

At a glance

Status

Active not recruiting

Phase

Sponsor

Sheffield Children's NHS Foundation Trust

Enrolment target

195

Start

23 Feb 2024

Estimated completion

31 Mar 2026

Respiratory Insufficiency

What is this study about?

When children and young people need help with their breathing, doctors sometimes use a method called Non-Invasive Ventilation (NIV). This support is given through a special mask that fits over their nose or nose and mouth. NIV is really important because it helps them breathe better, which can improve their quality of life and help them live longer. Without it, their breathing problems could become much more serious.

The challenge is that the mask must fit snugly and comfortably to work properly. However, standard masks are often made for adults and might not fit children and young people well, especially those with unusual face shapes. A poorly fitting mask can cause many problems. It can be uncomfortable, cause skin sores, disturb sleep due to loud air leaks, and even affect how their face bones grow. Currently, if a good-fitting mask isn't available, children might have to choose between a breathing tube inserted into their windpipe (which has its own risks) or not getting breathing support at all.

That's why we've developed a new system: a custom-made mask and headgear (the straps that hold the mask in place) using special 3D scanning and manufacturing. We want to test this new system with children and young people who are already using NIV but have problems with their current mask. We'll compare our new system with their old one, looking at how comfortable and well-fitting it is, and importantly, how well it helps their breathing. In a later part of the study, we'll also work on making the manufacturing process even faster and more automated by scanning many children to improve the software.

Key takeaways

A well-fitting breathing mask is crucial for children using NIV.
Current masks often don't fit children well, causing problems.
This study is testing new, custom-made masks using 3D technology.
The goal is to improve comfort, fit, and effectiveness of breathing support.
Participation involves trying on new masks and providing feedback.
This research aims to improve quality of life for children needing NIV.

Who may be eligible?

This study is specially designed for children and young people who are already receiving breathing support (NIV) at Sheffield Children’s Hospital and are having problems with their current mask.

You might be able to take part if you are between 1 month and 16 years old, and your current mask isn't fitting well. We are looking for children whose ventilator helps their own breathing that might be weak or slow, for example due to conditions like sleep apnoea. We are not looking for those who need a ventilator to take over all their breathing, or those who need extra oxygen.

Unfortunately, you won't be able to join if you don't attend with a parent or legal guardian who can allow you to take part, or if your family cannot understand English and we don't have an interpreter available. We also can't include children who are very unwell, or who already have a mask that fits them perfectly well.

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.

Are you between 1 month and 16 years old?
Do you currently use breathing support (NIV) through a mask?
Are you having problems with how well your current mask fits?
Does your ventilator help your own breathing, rather than take over completely?
Can you attend with a parent or legal guardian?
Can you/your parent understand English (or will an interpreter be available)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, we will first ask you to tell us about your current mask and how comfortable it is. Then, we will scan your face carefully to help create your custom mask. You'll then wear our new mask and headgear for a short time. We'll ask you to compare it to your current mask, letting us know how comfortable it feels and how well it fits. We'll also check how effectively it helps your breathing using special equipment. We will do this again later with an even more advanced custom mask, made using automated technology. We will also scan up to 120 children to help develop the software. The total time you'd be involved in the study will depend on which parts you take part in.

Potential risks and benefits

Taking part in this study could offer several potential benefits. There's a chance that our new custom-made mask and headgear could fit you better and be more comfortable than your current one, improving your breathing support and overall well-being. This could lead to fewer skin problems and better sleep. The main risk involved would be the time you spend having your face scanned and trying on a new mask. There's a very small chance the new mask might not fit perfectly at first, but we would work to adjust it. Remember, joining any study is completely your choice, and you are free to withdraw at any time without it affecting your usual medical care.

Locations (1)

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

Sheffield Children's Hospital, Sheffield, UK
Verified postcode
Sheffield, United Kingdom

Common questions

What is NIV?

NIV stands for Non-Invasive Ventilation. It's a way to help you breathe using a mask that fits over your nose or mouth, without needing a tube inside your body.

Why is a good mask fit so important?

A good fit means the mask is comfortable, doesn't leak air, and effectively helps your breathing. A poor fit can cause discomfort, skin sores, and reduce how well the treatment works.

What is 3D scanning?

3D scanning is a special technique that uses light to create a detailed, three-dimensional picture of your face, which helps us make a mask that fits your unique shape perfectly.

Will this study change my current breathing treatment?

This study is about providing a better mask, not changing your existing breathing treatment. You will continue to receive your usual care, and we will compare our new mask with your current one.

Who is funding this research?

The initial work on developing this mask, called the COMFORT study, was funded by the NIHR (National Institute for Health and Care Research), a major funder of health and social care research in the UK.