Bo A.D.F. Saals , Renger F. Witkamp , Anne Claire B. van Orten-Luiten , Heleen A. Kuijper-Tissot van Patot , Lonneke M. van der Meijden-Erkelens , Angelique Pijpers , Sebastiaan Overeem , Jop P. Mostert
{"title":"通过15项汇总N-of-1试验评估大麻二酚对多发性硬化症患者睡眠质量的影响:一项研究方案","authors":"Bo A.D.F. Saals , Renger F. Witkamp , Anne Claire B. van Orten-Luiten , Heleen A. Kuijper-Tissot van Patot , Lonneke M. van der Meijden-Erkelens , Angelique Pijpers , Sebastiaan Overeem , Jop P. Mostert","doi":"10.1016/j.cct.2025.108071","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Sleep disorders, including insomnia, are highly prevalent in individuals with multiple sclerosis (MS), significantly impacting quality of life. Patients frequently use cannabidiol (CBD) as an alternative to standard medical treatments for sleep disorders, yet its efficacy has not been rigorously investigated.</div></div><div><h3>Methods</h3><div>This study comprises 15 randomized, placebo-controlled N-of-1 trials evaluating the effect of pure CBD oil (10 % g/v) on sleep quality in MS patients. Each N-of-1 study consists of a two-week run-in period, followed by four treatment periods of three weeks, separated by a one-week washout. Participants receive both CBD and placebo twice in a randomized order. Treatment starts at 150 mg daily, increasing to 300 mg from week 2. Study outcomes are assessed during the final two weeks of each block. The primary outcome is sleep quality, measured by the Insomnia Severity Index (ISI). Secondary outcomes include patient-reported outcome measures of sleep recorded in a sleep-wake diary, and scores on the Checklist Individual Strength Fatigue-subscale (CIS-F), the Fatigue Severity Scale (FSS), and the Epworth Sleepiness Scale (ESS). Additionally, as a continuous proxy for fatigue, smartphone keyboard interactions will be collected using the Neurokeys application. Results from the individual N-of-1 trials will be aggregated for group-level analyses.</div></div><div><h3>Discussion</h3><div>This study aims to provide insight into the effects of a controlled CBD product on sleep quality in MS patients through an N-of-1 trial design. Given the substantial variability in sleep quality and the anticipated interindividual differences in CBD response, an N-of-1 design is considered a suitable methodological approach.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108071"},"PeriodicalIF":1.9000,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Evaluating the effect of cannabidiol on sleep quality in patients with multiple sclerosis using 15 aggregated N-of-1 trials: A study protocol\",\"authors\":\"Bo A.D.F. Saals , Renger F. Witkamp , Anne Claire B. van Orten-Luiten , Heleen A. Kuijper-Tissot van Patot , Lonneke M. van der Meijden-Erkelens , Angelique Pijpers , Sebastiaan Overeem , Jop P. Mostert\",\"doi\":\"10.1016/j.cct.2025.108071\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Sleep disorders, including insomnia, are highly prevalent in individuals with multiple sclerosis (MS), significantly impacting quality of life. Patients frequently use cannabidiol (CBD) as an alternative to standard medical treatments for sleep disorders, yet its efficacy has not been rigorously investigated.</div></div><div><h3>Methods</h3><div>This study comprises 15 randomized, placebo-controlled N-of-1 trials evaluating the effect of pure CBD oil (10 % g/v) on sleep quality in MS patients. Each N-of-1 study consists of a two-week run-in period, followed by four treatment periods of three weeks, separated by a one-week washout. Participants receive both CBD and placebo twice in a randomized order. Treatment starts at 150 mg daily, increasing to 300 mg from week 2. Study outcomes are assessed during the final two weeks of each block. The primary outcome is sleep quality, measured by the Insomnia Severity Index (ISI). Secondary outcomes include patient-reported outcome measures of sleep recorded in a sleep-wake diary, and scores on the Checklist Individual Strength Fatigue-subscale (CIS-F), the Fatigue Severity Scale (FSS), and the Epworth Sleepiness Scale (ESS). Additionally, as a continuous proxy for fatigue, smartphone keyboard interactions will be collected using the Neurokeys application. Results from the individual N-of-1 trials will be aggregated for group-level analyses.</div></div><div><h3>Discussion</h3><div>This study aims to provide insight into the effects of a controlled CBD product on sleep quality in MS patients through an N-of-1 trial design. Given the substantial variability in sleep quality and the anticipated interindividual differences in CBD response, an N-of-1 design is considered a suitable methodological approach.</div></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\"157 \",\"pages\":\"Article 108071\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2025-09-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1551714425002654\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714425002654","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Evaluating the effect of cannabidiol on sleep quality in patients with multiple sclerosis using 15 aggregated N-of-1 trials: A study protocol
Background
Sleep disorders, including insomnia, are highly prevalent in individuals with multiple sclerosis (MS), significantly impacting quality of life. Patients frequently use cannabidiol (CBD) as an alternative to standard medical treatments for sleep disorders, yet its efficacy has not been rigorously investigated.
Methods
This study comprises 15 randomized, placebo-controlled N-of-1 trials evaluating the effect of pure CBD oil (10 % g/v) on sleep quality in MS patients. Each N-of-1 study consists of a two-week run-in period, followed by four treatment periods of three weeks, separated by a one-week washout. Participants receive both CBD and placebo twice in a randomized order. Treatment starts at 150 mg daily, increasing to 300 mg from week 2. Study outcomes are assessed during the final two weeks of each block. The primary outcome is sleep quality, measured by the Insomnia Severity Index (ISI). Secondary outcomes include patient-reported outcome measures of sleep recorded in a sleep-wake diary, and scores on the Checklist Individual Strength Fatigue-subscale (CIS-F), the Fatigue Severity Scale (FSS), and the Epworth Sleepiness Scale (ESS). Additionally, as a continuous proxy for fatigue, smartphone keyboard interactions will be collected using the Neurokeys application. Results from the individual N-of-1 trials will be aggregated for group-level analyses.
Discussion
This study aims to provide insight into the effects of a controlled CBD product on sleep quality in MS patients through an N-of-1 trial design. Given the substantial variability in sleep quality and the anticipated interindividual differences in CBD response, an N-of-1 design is considered a suitable methodological approach.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.