Diagnostic Accuracy of SleepImage Technology for Detecting Respiratory Failure in Patients With Amyotrophic Lateral Sclerosis
This research is testing a piece of technology called SleepImage to see how accurately it can detect early signs of breathing difficulties in people living with Amyotrophic Lateral Sclerosis (ALS), often known as Motor Neuron Disease (MND). We want to find out if this device can efficiently tell when someone might benefit from breathing support, such as a non-invasive ventilator (NIV). The study isn't about using NIV itself, but about finding the most effective way to decide when that support would be most helpful. If you take part, we'll collect information about your breathing using the SleepImage device during your usual overnight sleep study and compare it with the results we'd normally get. This helps us understand if SleepImage offers a better way to monitor your breathing health.
At a glance
What is this study about?
This study is about finding better ways to detect breathing problems early in people with Amyotrophic Lateral Sclerosis (ALS), also known as Motor Neuron Disease (MND). ALS can affect the muscles used for breathing, and it's really important to know when these muscles might start to weaken. Currently, it can be tricky to tell exactly when someone might need a breathing machine, like a non-invasive ventilator (NIV), to help them breathe more easily, especially at night.
We're looking at a new device called SleepImage. This isn't a treatment; it's a monitoring device. It measures different things about your sleep and breathing to try and give a clear picture of your respiratory health. Think of it like a smart sensor that’s good at noticing subtle changes in how your body works as you sleep. The SleepImage system has been approved for use in the US and Europe, which means it meets certain safety and quality standards.
The main aim is to see if SleepImage can accurately and efficiently identify when breathing issues might be starting or getting worse, so that doctors can make timely decisions about when to offer breathing support. By understanding this better, we hope to improve how people with ALS are cared for, ensuring they get the right support at the right time.
Key takeaways
- Tests a device called SleepImage for early detection of breathing issues in ALS.
- Aims to improve decisions about when to provide breathing support.
- Involves using the SleepImage device during a routine overnight sleep study.
- No new medications or extra clinic visits are required.
- Participation could help future patients with ALS.
Who may be eligible?
To take part in this study, you need to be an adult, aged 18 or older, and have received a clear diagnosis of Amyotrophic Lateral Sclerosis (ALS) from a neurologist.
However, there are certain reasons why you might not be able to join. For example, if you already have other known breathing problems that aren't related to ALS, or if you have certain unstable heart conditions, you wouldn't be able to participate. Also, if you are currently using a breathing support machine called a non-invasive ventilator (NIV), this study wouldn't be suitable for you.
Finally, if someone isn't able to understand the study and give their permission to take part (for example, if they have certain types of dementia), they also wouldn't be able to join.
- Are you 18 years old or older?
- Have you been diagnosed with ALS by a neurologist?
- Do you currently have any other major lung problems?
- Do you have any unstable heart conditions?
- Are you currently using a special breathing machine (NIV)?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, your participation will mainly involve using the SleepImage device during one of your regular overnight sleep studies that you would have anyway. There will be no extra visits just for this specific study.
During your routine overnight sleep study, the SleepImage device will simply collect additional information about your breathing and sleep patterns alongside the usual measurements. You won't be given any new medications as part of this study, nor will there be any special follow-up appointments directly related to the SleepImage device. The total duration of your involvement will be limited to this one overnight assessment.
Potential risks and benefits
Locations (1)
- Royal Brompton HospitalLondon, United Kingdom· Recruiting
Common questions
What is ALS/MND?
ALS (Amyotrophic Lateral Sclerosis) is also known as Motor Neuron Disease (MND). It's a condition that affects the nerves in the brain and spinal cord, which can weaken muscles over time, including those used for breathing.
What is SleepImage technology?
SleepImage is a device that monitors your sleep and breathing. It helps doctors understand how well your body is working during the night, particularly how your heart and lungs are coordinating.
Will I have to take new medicine?
No, this study does not involve any new medicines. It's only about testing a monitoring device.
What is a 'routine overnight sleep study'?
This is a standard test where you sleep overnight in a clinic while sensors monitor your breathing, heart rate, and sleep patterns. You would already be having this test as part of your usual care.
Will this study change my treatment?
No, taking part in this study will not change the care or treatment you receive for your ALS. We are simply collecting extra information during your normal appointments.
How to find out more
Professor Michael Polkey
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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