Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

The CanISleepinMS Study: Effect of cannabidiol (CBD) on sleep quality in patients with multiple sclerosis, a series of 15 randomised, placebo-controlled N-of-1 trials

This research, called 'The CanISleepinMS Study,' is exploring if a specific CBD oil (Clinican CBD 10%) can improve sleep for people living with Multiple Sclerosis (MS) who experience insomnia. It's a special type of study where each participant tries both the CBD oil and a 'dummy' oil (a placebo) at different times, without knowing which they are taking. This helps researchers understand if the CBD itself is making a difference. The main way they'll measure sleep is through a questionnaire called the Insomnia Severity Index, along with sleep diaries and an app. They will also look at other sleep details like how long it takes to fall asleep. This is an early-stage study to see if further, larger research would be helpful.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Wageningen Research Stichting

Enrolment target

Start

17 Jan 2025

Insomnia

What is this study about?

This study is called 'The CanISleepinMS Study,' and it's looking into a common problem for people with Multiple Sclerosis (MS): trouble sleeping, also known as insomnia. Many people with MS find it hard to get a good night's rest, and this can affect their quality of life. This research aims to find out if a particular type of cannabis-based oil, called cannabidiol (CBD) — specifically Clinican CBD 10% oil — can help people with MS sleep better.

To do this, the study uses a clever design called an 'N-of-1 trial.' This means that each person taking part will act as their own 'control.' Over a period, you will try both the CBD oil and a 'dummy' oil (known as a placebo) at different times. Importantly, neither you nor the research team will know which oil you are taking at any given time. This helps ensure that any changes in sleep are truly due to the CBD and not just because you expect to feel better.

The main way researchers will measure how well the treatment works is by using a questionnaire called the Insomnia Severity Index. This helps them understand how severe your sleep problems are. They will also ask you to keep a sleep diary to record details like how long it takes you to fall asleep, how often you wake up, and how much total sleep you get. Additionally, you'll use a special app and complete other questionnaires to track your sleep and any other effects, including any side effects. This study is an early step to see if CBD could be a helpful option for managing sleep problems in MS, paving the way for larger studies if the results are promising.

Key takeaways

The study investigates if CBD oil (10% Clinican) can help people with MS who struggle with insomnia.
Each participant will try both the CBD oil and a 'dummy' oil, without knowing which they are taking.
Sleep will be measured using questionnaires, diaries, and a special app.
It's an early-stage study to explore potential benefits for future research.
Participants must be 18 years or older with MS and insomnia.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.

While the main criteria are being an adult with Multiple Sclerosis and experiencing insomnia, there will be other specific things the research team checks to make sure the study is safe and suitable for you. These will likely include reviewing your medical history and current medications to ensure the CBD oil won't interfere with anything else you're taking or any other health conditions you might have.

It's important that your doctor agrees you are eligible to take part and that you understand what the study involves. The research team will go through all the detailed requirements with you if you're interested in participating.

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 diagnosis of Multiple Sclerosis?
Do you experience significant trouble sleeping (insomnia)?
Are you able to follow study instructions and complete diaries/questionnaires?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be involved in a specific schedule where you'll try different treatments over time. You will likely start with a short 'run-in' period using a dummy oil (placebo) to get a baseline idea of your sleep. Then, you'll rotate between the active CBD oil and the dummy oil in a planned order. You won't know which one you're taking at any given time.

Your involvement will include regular assessments. You'll fill out questionnaires like the Insomnia Severity Index, keep a daily diary about your sleep (how long to fall asleep, how often you wake, total sleep time), and use a special app (Neurokeys). You'll also report any side effects you might experience. There will likely be visits to the clinic, but the exact number and frequency will be explained by the study team. The total duration of your participation will involve trying each treatment period, followed by reporting your experiences.

Potential risks and benefits

Taking part in this study could potentially help us understand if CBD oil can improve sleep for people with MS, which could ultimately benefit other patients in the future. For you personally, there's a chance you might experience improved sleep while on the active CBD oil. However, it's also possible that the CBD oil won't help your sleep, or you might be taking the dummy oil for periods of time. All medications, including CBD, can have side effects, and while CBD is generally well-tolerated, you might experience mild ones such as tiredness or digestive upset. The study team will closely monitor you for any side effects. Remember, participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is CBD oil?

CBD (cannabidiol) is a compound found in the cannabis plant. Unlike THC, another well-known compound, CBD does not make you feel 'high.' It's being studied for various health benefits.

What's a 'dummy' oil?

A 'dummy' oil, or placebo, looks and tastes just like the real CBD oil but contains no active ingredients. It helps researchers see if any improvements are truly due to the CBD or something else.

What is an 'N-of-1 trial'?

This is a special study design where each person tries both the real medicine and the 'dummy' medicine at different times. It means you are your own comparison, helping find out what works best for you.

Will I know if I'm taking the CBD or the dummy oil?

No, during the study, neither you nor the study team will know which oil you are taking. This is called 'blinding' and helps ensure fair and accurate results.

What is Multiple Sclerosis (MS)?

MS is a condition that affects your brain and spinal cord, which can lead to a wide range of symptoms, including difficulty sleeping for many people.