Effect of Valerian Root on Sleep in Rheumatoid Arthritis

描述(申请人提供)：睡眠障碍在类风湿性关节炎(RA)患者中很普遍，常规医疗保健不能充分缓解。草药安定已被证明可以改善客观和主观的睡眠指标，但尚未在RA患者中进行测试。这项拟议的研究是一项安慰剂对照的随机临床试验，调查与安慰剂相比，在RA患者就寝前一小时连续五个晚上使用缬草提取物(600毫克)是否会改善客观睡眠结果(提高睡眠效率、减少觉醒、缩短睡眠潜伏期)和主观睡眠结果(减少主观睡眠潜伏期、改善睡眠质量)。40名参与者将被随机接受安定或安慰剂(每组20人)。参与者将佩戴手腕活动记录仪(一种类似手表的设备，通过检测运动来提供睡眠测量)，并在七天内完成每日日志。头两天将进行基线测量(不治疗)。在接下来的五天里，参与者将在就寝前一小时服用安定或安慰剂。组间和受试者内的差异将使用混合效应方差分析模型进行分析。这项研究得到了弗吉尼亚大学GCRC的部分支持。

DESCRIPTION (provided by applicant): Sleep disturbances are prevalent among persons with rheumatoid arthritis (RA), and are not adequately relieved by conventional health care. The herb valerian has been demonstrated to improve objective and subjective measures of sleep, but has not been tested in persons with RA. The proposed study is a placebo controlled, randomized clinical trial investigating whether use of valerian extract (600 mg) one hour before bedtime for five nights will improve objective sleep outcomes (improved sleep efficiency, reduced awakenings, reduced sleep latency) and subjective sleep outcomes (reduced subjective sleep latency, improved sleep quality) compared to a placebo in persons with RA. Forty participants will be randomized to receive valerian or a placebo (20 per group). Participants will wear a wrist actigraph (a watch-like device that provides sleep measures by detecting movement) and complete daily logs for seven days. The first two days will be baseline measurement (no treatment). The following five days participants will take the valerian or placebo one hour before bedtime. Between-groups and within-subjects differences will be analyzed using mixed effects ANCOVA models. The study is supported in part by the University of Virginia GCRC.