Delivering Effective Non-Invasive Ventilation in Motor Neuron Disease
This study, called DENIM, is for people with Motor Neuron Disease (MND) who use a breathing machine called Non-Invasive Ventilation (NIV). NIV helps people with MND live longer and feel better, but it can be hard to use effectively. The study wants to test a new, more involved care plan that includes extra support from healthcare teams and using special technology to check the breathing machine from a distance. Researchers want to see if this new plan helps people use their NIV machine for longer each day compared to the usual care. This could improve how future patients with MND receive support for their breathing.
At a glance
What is this study about?
Motor Neuron Disease (MND) is a serious condition that affects about 1 in 300 people. Sadly, there's no cure, and most people eventually struggle with breathing because the muscles that help them breathe get weaker. A treatment called Non-Invasive Ventilation (NIV) can really help. It involves wearing a mask to support your breathing, and it's been shown to help people with MND live longer, feel better, and enjoy life more. However, many people find it difficult to use their NIV machine for long enough, or it doesn't work as well as it could, meaning they don't get the full benefits.
This study, called DENIM, wants to make sure everyone with MND gets the best possible support for their NIV, no matter where they live. Right now, not all hospitals use the best methods, and very few use modern technology like 'telemonitoring,' which lets doctors check on your breathing machine without you having to travel to the hospital. Our research has shown that this is often because doctors and nurses aren't always sure about the best ways to provide this support or how to work together as a team.
To fix this, we've developed a new plan based on ideas about how to improve healthcare. This plan aims to help healthcare teams provide better NIV support. We believe this new plan, which includes more intensive support and using telemonitoring, will help people with MND use their NIV machine more effectively. The study will compare this new plan with the usual care to see if it truly helps people use their NIV for more hours each day.
Key takeaways
- The study aims to improve support for MND patients using breathing machines (NIV).
- It tests a new care plan with more contact and remote monitoring from care teams.
- Participation involves two survey visits over 12 weeks, plus an oxygen monitor for one night.
- People aged 18+ with MND and breathing problems needing NIV may be eligible.
- You won't make extra hospital trips for the study.
- Your involvement helps improve future care for MND patients.
Who may be eligible?
This study is looking for people aged 18 or over who have been diagnosed with Motor Neuron Disease (MND) by a specialist doctor. You should also have breathing problems that your doctor thinks are serious enough to need long-term NIV treatment at home, and that need checking and adjusting within the first 12 weeks of the study.
You can start your NIV at home, at a clinic, or in the hospital (as long as your hospital stay is 3 days or less after starting NIV). It's important that you can understand the study information and agree to take part. If you agree to try NIV but find it hard to give full written consent, you might still be able to join if a close relative, carer, or a member of your care team agrees on your behalf.
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 18 years old or older?
- Do you have a confirmed diagnosis of Motor Neuron Disease (MND)?
- Do you have breathing problems that your doctor says need long-term NIV treatment at home?
- Is your NIV treatment expected to be adjusted or fine-tuned within 12 weeks?
- Are you able to understand the study and agree to take part, or can a close family member/carer agree for you?
What does participation involve?
If you decide to take part, you'll have two main visits. The first will be when your NIV machine is being set up, where you'll agree to join the study and fill out some initial questionnaires about your breathing. The second visit will be 12 weeks after you start NIV, where you'll complete the same questionnaires again. You won't need to go to any extra hospital appointments for this study.
Your care team will set up your NIV machine so it can send information to them and the research team using mobile internet. Depending on which hospital you're at, you might receive the usual amount of support from your care team, or you might get extra support. If you get extra support, your care team will use the information from your machine to check how you're doing. They'll contact you frequently (at least 4 times in the first two weeks, and at least 4 more times over the next 10 weeks) by phone, text, email, or video, to give advice and make adjustments to your machine from a distance if needed. You can also contact them with any concerns. The research team will look at the information from your machine (without your name attached) to see how many hours a day you use it. You'll also be asked to wear a small oxygen monitor on your finger for one night at home; it will be sent to you and collected afterwards.
Potential risks and benefits
Locations (12)
- Sheffield Teaching Hospitals NHS Foundation TrustCity onlySheffield, United Kingdom
- The Newcastle upon Tyne Hospitals NHS Foundation TrustCity onlyNewcastle upon Tyne, United Kingdom
- Guy's and St Thomas' NHS Foundation TrustCity onlyLondon, United Kingdom
- Salford Royal HospitalApproximateSalford, United Kingdom
- University Hospitals of Leicester NHS TrustCity onlyLeicester, United Kingdom
- Oxford University HospitalsCity onlyOxford, United Kingdom
- Barts Health NHS TrustCity onlyLondon, United Kingdom
- St George's University Hospitals NHS Foundation TrustCity onlyLondon, United Kingdom
- Norfolk and Norwich University Hospitals NHS Foundation TrustCity onlyNorwich, United Kingdom
- Leeds Teaching Hospitals NHS TrustCity onlyLeeds, United Kingdom
- University Hospitals of North Midlands NHS TrustUnverifiedStoke-on-trent, United Kingdom
- Nottingham University Hospitals NHS Trust - Queen's Medical Centre CampusUnverifiedNottingham, United Kingdom
Common questions
What is Non-Invasive Ventilation (NIV)?
NIV is a type of breathing support that uses a mask to help people breathe, especially if their breathing muscles are weak.
What is 'telemonitoring'?
Telemonitoring means your care team can check how your breathing machine is working from a distance, without you having to go to the hospital.
Will I have to go to extra hospital appointments?
No, you will not need to make any extra hospital visits just for this study.
Who is funding this study?
This study is funded by the National Institute for Health Research Health and Social Care Delivery Research in the UK.
How can I find out more?
You can contact the Denim Trial Manager at denimtrial@sheffield.ac.uk for more information.
How to find out more
Carla Girling
Always speak to your GP or specialist before deciding to take part in a study.
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