RecruitingOBSERVATIONAL

Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis

This study explores the connection between sleep disturbances, feeling tired (fatigue), and thinking difficulties in people with Multiple Sclerosis (MS). Many people with MS experience significant fatigue, which can impact their daily lives and work. Sleep problems are also common but often not identified or treated, and might contribute to this fatigue. Researchers aim to use detailed sleep studies (polysomnography) to better understand how common sleep problems are in MS patients with fatigue, and if they are linked to issues with memory and thinking. The study will compare different types of MS and also look at whether certain MS medications have an effect. They will also use Artificial Intelligence (AI) to make analysing sleep data easier for future research. This is an observational study, meaning participants won't receive new treatments, but will be carefully monitored.

At a glance

Status

Recruiting

Sponsor

Heinrich-Heine University, Duesseldorf

Enrolment target

837

Start

01 Nov 2024

Estimated completion

01 Dec 2028

Multiple Sclerosis Remitting-Relapsing Multiple Sclerosis Primary Progressive Multiple Sclerosis Secondary Progress Multiple Sclerosis Fatigue Syndrome, Chronic Sleep Disorders

What is this study about?

Many people living with Multiple Sclerosis (MS) find that tiredness, known as fatigue, is one of their most challenging symptoms. This fatigue can make daily activities difficult and even affect their ability to work. We know that sleep problems often go hand-in-hand with MS, but sometimes these issues aren't fully recognised or treated. This study wants to understand this connection better. Researchers will use special sleep tests called polysomnography, which are very detailed, to see exactly what's happening with people's sleep. They want to find out how common sleep disorders are in MS patients who feel tired, and if these sleep problems are linked to difficulties with memory, concentration, and other thinking skills.

The study also aims to compare sleep quality and the types of sleep problems found across different forms of MS, such as relapsing-remitting, primary progressive, and secondary progressive MS. They are also curious to see if the type of medication a person is taking for their MS has any impact on their sleep or how tired they feel. Importantly, this project will also explore how to use Artificial Intelligence (AI) to make analysing all the detailed sleep data faster and more efficient. This could help doctors and researchers in the future to understand sleep issues better and develop new ways to help people with MS.

This is an "observational study" which means participants won't be given any new treatments or medicines as part of the study. Instead, the researchers will carefully observe and record information about their sleep, fatigue, and other health details over time. This approach helps us gain a deeper understanding of the natural course and connections between these symptoms. By doing this, they hope to get a much clearer picture of how sleep problems contribute to fatigue in MS, which could lead to better ways to help manage these symptoms in the future.

Key takeaways

This study explores the link between sleep problems, fatigue, and thinking issues in MS.
It uses detailed overnight sleep tests (polysomnography) to understand sleep quality.
The study also investigates different types of MS and the impact of certain MS medications.
Artificial Intelligence (AI) will be used to help analyse sleep data for future research.
It's an observational study; no new treatments are given.
Findings could lead to better ways to manage fatigue and sleep in MS patients.

Who may be eligible?

You might be able to join this study if you are aged between 18 and 79. You need to be able to hear and see well enough (with glasses or hearing aids if you normally use them) to do some simple tests. You also need to be able to understand and speak German well enough to take part.

If you have been diagnosed with MS (using the specific criteria from 2017) and experience at least mild fatigue – measured as 43 points or more on a special fatigue scale – then you could be eligible for the MS group. There is also a control group for people who have sleep complaints but do not have MS, and they will also need to be aged 18-79.

You won't be able to join if you are outside the age range (under 18 or over 79), or if you have another neurological condition besides MS (except for migraines). You also can't take part if you are taking any medicines that might affect your sleep test results, such as certain tranquilisers, or if you can't give your informed consent.

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 18 and 79 years old?
Do you have a confirmed diagnosis of Multiple Sclerosis?
Do you experience at least mild fatigue (as described by your doctor or on a fatigue questionnaire)?
Can you hear and see well enough (with aids if needed) to do some tests?
Can you understand and speak German adequately?
Are you NOT taking any medications that might affect sleep test results (like certain tranquilisers)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in what's called an "observational study." This means you won't be given any new treatments or medicines. Instead, the researchers will gather information about you. This will involve an overnight stay in a sleep lab where your sleep will be carefully monitored using a test called polysomnography. You will also have a thorough health check-up, some tests to assess your memory and thinking skills, and you'll fill out several questionnaires about your tiredness, sleep quality, how sleepy you feel during the day, and your mood (like whether you feel down or anxious). The total duration of your participation will include these assessments and the overnight sleep study; it's a one-off assessment, not ongoing visits. There are no follow-up visits involved for you.

Potential risks and benefits

Participating in this study could offer the benefit of a detailed sleep assessment, which might help you and your doctor better understand any underlying sleep issues you have. You'll also be contributing valuable information that could help improve the care and understanding of fatigue and sleep problems for other people with MS in the future. As an observational study, there are no new medications or invasive procedures, so risks are generally low. The main inconvenience might be the time commitment for the overnight stay and assessments, and the minor discomfort of having sensors attached for the sleep study. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

University Hospital Düsseldorf
Verified postcode
Düsseldorf, Germany· Recruiting
Maria Hilf Clinics
Verified postcode
Mönchengladbach, Germany· Recruiting

Common questions

What is 'polysomnography'?

It's a special sleep test done in a lab overnight. It records your brain waves, breathing, heart rate, and movements to see how well you sleep.

Will I receive any new treatment in this study?

No, this is an observational study. You won't receive new treatments or medicines; researchers will just gather information.

What does 'fatigue' mean in this study?

Fatigue means feeling very tired and lacking energy, which can be due to your MS. The study looks at how this tiredness is linked to sleep problems.

What is AI's role in this study?

AI (Artificial Intelligence) will be used to help analyse the detailed sleep data more quickly and efficiently, making future research easier.

Will my regular MS treatment change if I join?

No, participating in this study will not affect your current MS treatment or your usual medical care.

How to find out more

Carolin Balloff, Dr. rer. nat.

carolin.balloff@gmail.com +4917622970340 Official trial record

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