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

IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
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
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引用次数: 0

摘要

背景:睡眠障碍,包括失眠,在多发性硬化症(MS)患者中非常普遍,显著影响生活质量。患者经常使用大麻二酚(CBD)作为标准药物治疗睡眠障碍的替代方案,但其疗效尚未得到严格调查。方法:本研究包括15个随机、安慰剂对照的N-of-1试验,评估纯CBD油(10 % g/v)对MS患者睡眠质量的影响。每个N-of-1研究包括两周的磨合期,随后是四个为期三周的治疗期,中间有一个为期一周的洗脱期。参与者按随机顺序接受CBD和安慰剂两次。治疗从每天150 毫克开始,从第2周开始增加到300 毫克。研究结果在每个模块的最后两周进行评估。主要结果是睡眠质量,由失眠严重指数(ISI)衡量。次要结果包括患者报告的睡眠结果测量,记录在睡眠-觉醒日记中,以及检查表个人力量疲劳亚量表(CIS-F),疲劳严重程度量表(FSS)和Epworth嗜睡量表(ESS)的分数。此外,作为疲劳的连续代理,智能手机键盘交互将使用Neurokeys应用程序收集。单个N-of-1试验的结果将汇总用于组水平分析。讨论:本研究旨在通过N-of-1试验设计,深入了解受控CBD产品对MS患者睡眠质量的影响。考虑到睡眠质量的巨大可变性和CBD反应的预期个体间差异,N-of-1设计被认为是一种合适的方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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.
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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
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.
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