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Study on the Effect of Cannabidiol (CBD) on Sleep Quality in Multiple Sclerosis Patients with Insomnia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The CanISleepinMS Study is focused on understanding how the substance cannabidiol (CBD) affects sleep quality in people with Multiple Sclerosis (MS) who experience insomnia. Insomnia is a condition where individuals have trouble falling asleep or staying asleep, which can significantly impact daily life. The study will use a product called Clinican CBD 10% oil, which is an oromucosal solution, meaning it is taken by mouth and absorbed through the tissues in the mouth. Participants will be randomly assigned to receive either the CBD oil or a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to investigate the effect of CBD on MS patients with impaired sleep quality. Participants will take part in a series of 15 individual trials, where they will receive either the CBD oil or a placebo over a period of time. Throughout the study, participants will be asked to keep a daily diary to record their sleep patterns and any other experiences they have. This will help researchers understand how CBD might improve sleep quality in people with MS.

Participants will also use a mobile app called the Neurokeys app to help track their sleep and other related outcomes. The study will look at various aspects of sleep, such as how long it takes to fall asleep, the number of times a person wakes up during the night, and the total amount of sleep time. By the end of the study, researchers hope to gather valuable information on whether CBD can be a helpful treatment for improving sleep in people with MS.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial phase
Upon joining the study, the participant will begin by using the Neurokeys app daily. This app is used to record sleep patterns and other relevant data.
Participants will be required to fill in a daily digital diary during the treatment phase. This diary will be sent to the study nurse or research assistant once a week.
Step 2
Treatment phase
Participants will receive either Clinican CBD 10% oil or a placebo. The CBD oil is an oromucosal solution, meaning it is administered orally.
The dosage and frequency of administration will be determined by the study protocol, and participants will be informed accordingly.
Participants must refrain from using any other cannabis products, sleep-promoting supplements, or new sleep-facilitating treatments during this phase.
Participants are required to avoid driving or operating machinery within 8 hours after taking the investigational product.
Step 3
Monitoring and data collection
Participants will be contacted by the research assistant at least twice a week to monitor progress and address any concerns.
Blood samples will be taken at the screening visit and two additional times during the treatment phase to monitor health and response to the treatment.
Step 4
Evaluation phase
The primary outcome will be assessed using the Insomnia Severity Index (ISI) questionnaire.
Secondary outcomes will include sleep-related metrics such as Sleep Onset Latency, number of awakenings, Wake time After Sleep Onset, Total Sleep Time, and Sleep Efficiency.
Non-sleep outcomes like the number of nocturnal voiding and any adverse events will also be recorded daily.
Step 5
Completion
The study is estimated to end by August 2025. Participants will be informed of the results and any further steps if necessary.

Who can join the trial?

28 criteria

Must have a diagnosis of **MS** (Multiple Sclerosis) confirmed by a neurologist.
Must not be breastfeeding during the trial.
Must have a complaint of long-term sleep problems, diagnosed as **insomnia** by an MS neurologist and a sleep specialist.
Must be willing to continue current medications as advised by study doctors.
Must agree not to start any new medications that help with sleep until the study ends.
Must agree not to use any other cannabis products until the study is completed.
Must agree not to use any supplements that help with sleep, like L-tryptophan, valerian, or melatonin, during the study.
Must be willing to continue non-medication treatments as advised by study doctors.
Must agree not to start any new non-medication treatments for sleep until the study ends and keep lifestyle stable.
Must be willing to give informed consent, meaning you understand and agree to participate in the study.
Must be willing to fill out a daily digital diary during the study and send it to the study team weekly.
Must be willing to be contacted by the research assistant at least twice a week during the study.
Must have a type of MS called relapsing-remitting, primary progressive, or secondary progressive.
Must be willing to use the Neurokeys app on a mobile phone daily.
Must be willing to have blood samples taken at the start and during the study.
Must agree not to drive or operate machinery within 8 hours after taking the study product until the study ends.
Must agree not to work night shifts or travel across time zones until the study is completed.
Must agree not to consume too much caffeine (more than 1 cup of coffee or 1 energy drink) or alcohol (more than 1 serving) in the evening, 6 hours before bedtime.
Must agree not to consume grapefruit, Seville oranges, limes, or pomelos during the study, as these can affect how the body processes CBD.
Must agree not to change diet or beverages during the study and keep eating habits stable.
Must have an **Expanded Disability Status Scale (EDSS)** score of less than 7.5, which measures disability in MS.
Must not have had an MS relapse for at least 6 months before starting the study.
Must not have changed immunomodulating therapy for at least 3 months before starting the study.
Must not have changed other chronic condition medications for at least 6 weeks before starting the study.
Must be at least 18 years old at the time of screening.
Must have a **Body Mass Index (BMI)** of less than 35.0 kg/m² at the time of screening. BMI is a measure of body fat based on height and weight.
Must have elevated levels of liver enzymes (ALT, AST) up to twice the normal limit, as this is common in MS patients.
Must not plan to become pregnant or be involved in pregnancy during the trial.

Who cannot join the trial?

4 criteria

Patients who are not experiencing insomnia, which means having trouble sleeping.
Patients who are not diagnosed with MS, which stands for Multiple Sclerosis, a condition affecting the brain and spinal cord.
Patients who are younger than 18 years old or older than 65 years old.
Patients who are part of a vulnerable population, meaning they need special protection or care.

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Rijnstate Ziekenhuis Stichting
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Arnhem, The Netherlands

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Investigated drugs

Cannabidiol (CBD) is a compound derived from the cannabis plant. In this trial, it is being studied for its potential to improve sleep quality in patients with multiple sclerosis. CBD is known for its calming effects and is being tested to see if it can help people with MS who have trouble sleeping.

Cannabidiol

What is already known about the treatment

Cannabidiol (CBD) – Cannabidiol is administered orally, typically in the form of oil or capsules. It is currently being studied in clinical trials for its potential benefits in improving sleep quality, particularly in patients with multiple sclerosis who experience insomnia. The main therapeutic indication being explored is its ability to enhance sleep quality. At the molecular level, CBD interacts with the endocannabinoid system, which may help regulate sleep patterns and reduce anxiety. It is classified pharmacologically as a cannabinoid, a compound derived from the cannabis plant.

Investigated diseases

Insomnia – Insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or waking up too early and not being able to return to sleep. It can lead to feeling tired upon waking and can affect daily functioning. The condition may be acute, lasting a few days or weeks, or chronic, persisting for a month or longer. Insomnia can be caused by stress, irregular sleep schedules, poor sleeping habits, mental health disorders, or other medical conditions. It often results in reduced energy, mood disturbances, and decreased performance in work or school.