Slaapkwaliteit Sleep quality
Conditions
Interventions
In week 1 of the treatment phase, trial participants take either a solution of
CBD (10% w/v) in almond oil for oromucosal administration at a dose of 150 mg
once daily or a placebo, 30 minutes befor
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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 1 cup of coffee or 1 serving of energy drink) and alcohol (> 1 serving) in the ev
Exclusion criteria
Exclusion criteria: • 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 • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Diary measurements (sleep-related outcomes: number of awakenings (NA), Sleep Onset Latency (SOL), Sleep Efficiency (SE), Wake time After Sleep Onset (WASO), Total Sleep Time (TST); non-sleep outcomes: changes in number of nocturnal voidings, number, type, and severity of adverse events (AEs); Epworth Sleepiness Scale (ESS), Fatigue Severity Scale (FSS), Checklist Individual Strength Fatigue-subschaal (CIS-F); Keystroke features of the Neurocast® App, a 24/7 digital measure of fatigue, rest and activity patterns, and daily functioning based on dynamics of keyboard key strokes on personal smartphones; furthermore answers on daily pop-up questions for Numeric Rating Scale (NRS) scores for pain, spasms, and fatigue; | — |
Countries
Netherlands
Outcome results
None listed