Sleep QualityPhase 2CanISleepinMSNCT07840924
The CanISleepinMS Study: Effect of Cannabidiol (CBD) on Sleep Quality in Patients With Multiple Sclerosis
A Phase 2 study testing Cannabidiol Oil in people with Sleep Quality and Multiple Sclerosis, run by Wageningen University at 1 site in Netherlands.
Trial summary
Evaluating the effect of 300 mg purified cannabidiol (CBD) on sleep quality in patients with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Quality, Multiple Sclerosis, Insomnia
- What is being tested?
- Cannabidiol Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Mar 2024to 28 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of MS confirmed by a neurologist, based on the revised 2010 or 2017 McDonalds criteria
- Relapsing-remitting or primary or secondary progressive MS
- Expanded Disability Status Scale (EDSS) score <7.5
- No relapse for at least 6 months before the screening visit
- No changes in immunomodulating therapy stable
- For at least 3 months before the screening visit; no changes in use of other medications used for chronic conditions for at least 6 weeks before the screening visit (e.g. anti-depressant drugs, antidiabetics)
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- Age minimally 18 years at the time of screening
- Body Mass Index (BMI) < 35.0 kg/m2 at the moment of screening
- Elevated levels of transaminases (ALAT, ASAT) until twice the Upper Limit of Normal (2x ULN) are allowed, as elevation of these levels is a common finding in MS patients
- No plans to (be involved in) getting pregnant during the trial
- No breast feeding during the trial
- A complaint of chronic impairment of sleep quality, leading to a diagnosis of insomnia by an MS neurologist and an experienced somnologist. In this context, insomnia is defined as difficulties initiating and/or maintaining sleep or too early awakenings, despite adequate opportunity and circumstances for sleep, resulting in some form of daytime impairment. Causes include psychophysiological insomnia, insomnia due to mental disorders like depression, and insomnia secondary to other MS-related symptoms like spasticity, pain or nocturnal voidings.
- Diagnosis will be based on fulfilment of the ICDS-3 criteria of insomnia and an ISI score of minimally 15 (threshold for clinical insomnia).
- Continuation of pharmacological treatments will be at the discretion of the study physicians.
- Willing and able to refrain from new, sleep-facilitating pharmacological treatments until the end of the treatment phase of the study
- Willing and able not to use any other cannabis product until completion of the study
- Willing and able not to use any supplement that could promote sleep (e.g. L-tryptophan,
- valerian, melatonin) during the treatment phase of the study.
- Continuation of non-pharmacological treatments will be at the discretion of the study physicians.
- Willing and able to refrain from new, sleep-facilitating nonpharmaceutical interventions until the end of the treatment phase of the study. Lifestyle should be kept as stable as possible.
- Willing and able to give informed consent
- Willing and able to fill in a daily digital diary during the treatment phase, to send this to the study nurse or research assistant once a week, and to be contacted by the research assistant minimally twice a week during the treatment phase of the study
- Willing and able to use the Neurokeys app (thus mobile phone) daily
- Willing to have blood sampled at the screening visit and have another
- two blood draws during the treatment phase of the study
- Willing and able not to drive a car or operate machinery within 8 hours after intake of the investigational product until the end of the treatment phase of the study
- Willing and able not to do evening/night shift work and not to cross time zones until the completion of the study
- Willing and able to refrain from excessive use of excessive use of caffeine (> 1 cup of coffee or 1 serving of energy drink) and alcohol (> 1 serving) in the evening, 6 hours before going to bed
- Willing and able to refrain from (products of) grapefruit, Seville oranges (used in marmalade), limes and pomelos during the treatment phase of the study
- Willing and able to refrain from experimenting with timing and type of diet, and beverages during the treatment phase of the study. A participant's dietary intake pattern should be kept as stable as possible during the treatment phase as there are numerous dietary components other than furanocoumarins that may influence CBD bioavailability
Who cannot join
- Circadian rhythm sleep-wake disorders, sleep related breathing disorders (such as moderate to severe obstructive sleep apnea, central breathing disorders during sleep, or sleep-related stridor that require prompt specific treatment), current delayed sleep phase syndrome where wake up time is regularly later than 8.00 a.m., or a sleep problem fulfilling the ICSD3 criteria of parasomnias
- Good response to initial treatment for the assessed sleep disorder
- Use of a benzodiazepine or other sleep medication, unless the patient has tapered off the sleep medication before the moment of inclusion
- Liver disease or blood levels of transaminases (ALAT, ASAT) above 3x ULN, as long term administration of high doses of CBD may affect (although reversible) liver function
- History of severe psychiatric comorbidity
- Increased risk of suicidal thoughts or behaviour
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- History of drug or alcohol abuse
- Known or suspected hypersensitivity to cannabinoids or to excipients of the formulation of the investigational product - almond oil
- History of use with CBD oil prepared by pharmacy Clinical Cannabis Care
- Structural or recreational use of a cannabinoid product < 2 months before screening
- Whether the use of any of the following medications is a reason for exclusion will be at the discretion of the study physicians and delivery pharmacist.
- drugs with risk of liver injury; the decision of exclusion will be made in consultation with the MS neurologists and the pharmacist that provides the CBD product.
- drugs with risk of interaction with CBD. Data on the potential drug-CBD interactions below are based on mechanistic and clinical studies:
- drugs of which their biotransformation is primarily dependent on the cytochrome P450 enzymes CYP2C19 and CYP3A
- drugs that are inducers or inhibitors of enzymes of which CBD is a substrate: CYP2C19, CYP3A4.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluating the effect of 300 mg purified cannabidiol (CBD) on sleep quality in patients with multiple sclerosis (MS).
Read the detailed description
The investigators conducted a series of 16 aggregated randomized, placebo-controlled N-of-1 trials to investigate the effect of purified cannabidiol (CBD) oil on nocturnal sleep quality in patients with multiple sclerosis. Each participant completed four treatment periods: two with CBD (300 mg daily) and two with placebo. The primary outcome is the insomnia severity index (ISI). Secondary outcomes included a sleep-wake diary and scores on the Checklist Individual Strength Fatigue subscale (CIS-F), Fatigue Severity Scale (FSS), and Epworth Sleepiness Scale (ESS).
- Conditions
- Sleep Quality, Multiple Sclerosis, Insomnia
- Being tested
- Cannabidiol Oil
- Keywords
- Cannabidiol, Sleep, MS, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol OilDrug
Also called CBD
This study aims to compare the efficacy of CBD oil with a placebo to manage nocturnal sleep quality in MS patients.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The investigational placebo consists of almond oil with a subtle blood orange flavor. Receives: Drug: Cannabidiol Oil |
| Cannabidiol Oil | Experimental | The Investigational Medicinal Product consists of purified cannabidiol in almond oil. Receives: Drug: Cannabidiol Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
The ISI is a validated tool to assess insomnia and sensitive to treatment response. The ISI is composed of seven items, each with a 5-point rating scale ranging between and to 4 (no to severe problem). Higher scores indicate worse outcomes. A total score between 0-7, 8-14, 15-21, and 22-28 is explained as no, sub threshold, moderate, and severe insomnia, respectively. A change in ISI score of 5 is considered as a clinical improvement.
Measured: The ISI was administered at baseline and at the end of every treatment block, measuring perceived severity of insomnia over the last two weeks (weeks 2,5,9,13,17)
Secondary outcomes (14)
Sleep diary - total sleep time
Total sleep time in minutes, higher scores indicate better outcomes
Measured: Daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
Epworth Sleepiness Scale (ESS)
The ESS assesses excessive daytime sleepiness and consists of 8 items, each scored on a 0-3 point scale. Higher scores indicate worse outcomes. Score categories include 1-10, 11-14, 15-17, 18-24: no, mild, moderate, severe sleepiness, respectively.
Measured: At the end of every two weeks in each of 4 treatment periods (weeks 1, 2, 4, 5, 8, 9, 12, 13, 16, 17)
Fatigue Severity Scale (FSS)
Measures symptoms of fatigue using a 9-item scale scored from 1 to 7. Higher scores indicate worse outcomes.
Measured: At the end of every two weeks in each of 4 treatment periods (weeks 1, 2, 4, 5, 8, 9, 12, 13, 16, 17)
Checklist Individual Strength Fatigue subscale (CIS-F)
Indicator of fatigue and related behavioral aspects, containing 20 statements with a 7-point Likert scale over four categories: subjective fatigue, concentration, motivation, and activity. Higher scores indicate worse outcomes.
Measured: At the end of every two weeks in each of 4 treatment periods (weeks 1, 2, 4, 5, 8, 9, 12, 13, 16, 17)
Keystroke dynamics
Outcomes of the NeuroKeys application (i.e. clusters of keystroke dynamics including typing speed and motion sensor data (accelerometer, gyroscope and ambient light).
Measured: Continuously and daily during the 18-week study period.
Sleep diary - sleep onset latency
The time (minutes) it takes to fall asleep, higher scores indicate worse outcomes.
Measured: Daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
Sleep diary - number of awakenings
Number of nocturnal awakenings, higher scores indicate worse outcomes
Measured: Daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
Sleep diary - sleep efficiency
Sleep Efficiency (percentage)- higher scores indicate better outcomes, calculated as as the ratio of total sleep time to time in bed (multiplied by 100 to yield a percentage).
Measured: Daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
Sleep diary - time in bed
Total time spent in bed (minutes). The score is interpreted in relation to total sleep time and sleep efficiency,
Measured: Daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
Sleep diary - wake after sleep onset
Total time (minutes) spent awake after the first falling asleep until getting up to start the day. Higher scores indicate worse outcomes.
Measured: Daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
NRS - fatigue
Numeric Rating Scale for fatigue, measured on a 0-6 point scale. Higher scores indicate worse outcomes.
Measured: Once daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
NRS - pain
Numeric Rating Scale for pain, measured on a 0-6 point scale. Higher scores indicate worse outcomes.
Measured: Once daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
NRS - spasticity
Numeric Rating Scale for MS related spasticity, measured on a 0-6 point scale. Higher scores indicate worse outcomes.
Measured: Once daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
NRS - Noctural Voiding
Frequency of nocturnal voiding, measured on a 0-6 point scale. Higher scores indicate worse outcomes.
Measured: Once daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start26 Mar 2024
- Primary completion28 Mar 2026
- Study completion28 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A series of 16 N-of-1 trials; each N-of-1 trial will consist of a double crossover performed in a single patient. Within a crossover, the interventions with either CBD or placebo are randomised and double blinded. After a run-in period of 2 weeks, there will be 4 treatment periods of 3 weeks, separated from each other by a washout of 1 week.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationaal MS Fonds, Rijnstate Hospital, Sleep Medicine Centre Kempenhaeghe
- Responsible party
- Principal investigator, Renger Witkamp, Wageningen University
- Investigators
- Renger Witkamp, prof.dr., Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840924
- Sponsor's protocol ID
- 6130034080
- Other IDs
- 2024-518280-35-00
- Acronym
- CanISleepinMS
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CanISleepinMS Study: Effect of Cannabidiol (CBD) on Sleep Quality in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07840924
- Acronym / sponsor ID
- CanISleepinMS / 6130034080
- Conditions
- Sleep Quality, Multiple Sclerosis, Insomnia
- Keywords
- Cannabidiol, Sleep, MS, Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Nationaal MS Fonds, Rijnstate Hospital, Sleep Medicine Centre Kempenhaeghe
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 28 Mar 2026 (actual)
- Study completion
- 28 Mar 2026 (actual)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the effect of 300 mg purified cannabidiol (CBD) on sleep quality in patients with multiple sclerosis (MS).
Detailed description
The investigators conducted a series of 16 aggregated randomized, placebo-controlled N-of-1 trials to investigate the effect of purified cannabidiol (CBD) oil on nocturnal sleep quality in patients with multiple sclerosis. Each participant completed four treatment periods: two with CBD (300 mg daily) and two with placebo. The primary outcome is the insomnia severity index (ISI). Secondary outcomes included a sleep-wake diary and scores on the Checklist Individual Strength Fatigue subscale (CIS-F), Fatigue Severity Scale (FSS), and Epworth Sleepiness Scale (ESS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A series of 16 N-of-1 trials; each N-of-1 trial will consist of a double crossover performed in a single patient. Within a crossover, the interventions with either CBD or placebo are randomised and double blinded. After a run-in period of 2 weeks, there will be 4 treatment periods of 3 weeks, separated from each other by a washout of 1 week.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Cannabidiol OilThe investigational placebo consists of almond oil with a subtle blood orange flavor. |
| Cannabidiol Oil | Experimental | Drug: Cannabidiol OilThe Investigational Medicinal Product consists of purified cannabidiol in almond oil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- A diagnosis of MS confirmed by a neurologist, based on the revised 2010 or 2017 McDonalds criteria
- Relapsing-remitting or primary or secondary progressive MS
- Expanded Disability Status Scale (EDSS) score <7.5
- No relapse for at least 6 months before the screening visit
- No changes in immunomodulating therapy stable
Key exclusion criteria (15 listed)
- Circadian rhythm sleep-wake disorders, sleep related breathing disorders (such as moderate to severe obstructive sleep apnea, central breathing disorders during sleep, or sleep-related stridor that require prompt specific treatment), current delayed sleep phase syndrome where wake up time is regularly later than 8.00 a.m., or a sleep problem fulfilling the ICSD3 criteria of parasomnias
- Good response to initial treatment for the assessed sleep disorder
- Use of a benzodiazepine or other sleep medication, unless the patient has tapered off the sleep medication before the moment of inclusion
- Liver disease or blood levels of transaminases (ALAT, ASAT) above 3x ULN, as long term administration of high doses of CBD may affect (although reversible) liver function
- History of severe psychiatric comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol OilAlso: CBDThis study aims to compare the efficacy of CBD oil with a placebo to manage nocturnal sleep quality in MS patients. | Drug | Cannabidiol Oil, Placebo |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: The ISI was administered at baseline and at the end of every treatment block, measuring perceived severity of insomnia over the last two weeks (weeks 2,5,9,13,17)
The ISI is a validated tool to assess insomnia and sensitive to treatment response. The ISI is composed of seven items, each with a 5-point rating scale ranging between and to 4 (no to severe problem). Higher scores indicate worse outcomes. A total score between 0-7, 8-14, 15-21, and 22-28 is explained as no, sub threshold, moderate, and severe insomnia, respectively. A change in ISI score of 5 is considered as a clinical improvement.
14 secondary outcomes
Sleep diary - total sleep time
Time frame: Daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
Epworth Sleepiness Scale (ESS)
Time frame: At the end of every two weeks in each of 4 treatment periods (weeks 1, 2, 4, 5, 8, 9, 12, 13, 16, 17)
Fatigue Severity Scale (FSS)
Time frame: At the end of every two weeks in each of 4 treatment periods (weeks 1, 2, 4, 5, 8, 9, 12, 13, 16, 17)
Checklist Individual Strength Fatigue subscale (CIS-F)
Time frame: At the end of every two weeks in each of 4 treatment periods (weeks 1, 2, 4, 5, 8, 9, 12, 13, 16, 17)
Keystroke dynamics
Time frame: Continuously and daily during the 18-week study period.
Sleep diary - sleep onset latency
Time frame: Daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
Sleep diary - number of awakenings
Time frame: Daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
Sleep diary - sleep efficiency
Time frame: Daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
Sleep diary - time in bed
Time frame: Daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
Sleep diary - wake after sleep onset
Time frame: Daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
NRS - fatigue
Time frame: Once daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
NRS - pain
Time frame: Once daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
NRS - spasticity
Time frame: Once daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
NRS - Noctural Voiding
Time frame: Once daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renger Witkamp, prof.dr. principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol Oil in people with Sleep Quality and Multiple Sclerosis, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: The ISI was administered at baseline and at the end of every treatment block, measuring perceived severity of insomnia over the last two weeks (weeks 2,5,9,13,17)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.