The use of valerian on sleep in persons with restless legs syndrome

描述（由申请人提供）：主要的长期职业目标是在睡眠和补充和替代医学（CAM）领域发展一个强有力的持续资助的研究项目。目前的目标是扩大睡眠研究的技能和经验。合并过去的学术工作在老年护理，文化多样性和补充和替代医学框架提出的研究。不宁腿综合症（RLS）是一种常见的睡眠障碍，影响了多达15%的人口，尤其是老年人。对患者来说非常痛苦，RLS的表现包括休息或就寝时腿部的刺激性感觉，只有通过运动才能缓解。这些症状影响睡眠发作和睡眠质量，常常导致抑郁、焦虑和生活质量差。由于用于治疗RLS的药物的副作用，治疗经常停止工作或停止。缬草作为一种补充治疗可能对睡眠倒睡症患者有益。缬草是一种已经使用了几个世纪的助眠剂，它的作用类似于苯二氮卓类药物，没有认知障碍、宿醉效应或成瘾等负面副作用。虽然缺乏科学严谨的安慰剂对照试验，但缬草已被证明在减少睡眠发作和改善睡眠结果方面非常有希望。本初步研究的具体目的是通过一项安慰剂对照的II期临床试验来评估缬草的有效性，该试验采用交叉设计，研究睡眠和症状严重程度、抑郁和生活质量在基线和6周时的结果。该试点计划将比较缬草在33名受试者干预6周后的有效性，采用自我报告测量和客观睡眠测量，包括活动记录仪、精神运动警戒任务（PVT）、血清和尿液分析。研究结果有望提供初步数据，以支持缬草对时间反应剂量的更大规模随机临床试验，并比较缬草与苯二氮卓类药物在RLS中的治疗结果。一个系统的计划（学术课程，研究培训，参加会议，研讨会和座谈会）被描述为获得生物医学睡眠科学背景以及睡眠医学知识，使候选人成为一名独立的睡眠护士研究员。

DESCRIPTION (provided by applicant): The primary long term career objective is to develop a strong consistently funded program of research in the area of sleep and complementary and alternative medicine (CAM). The immediate objective is to expand skills and experiences in sleep research. The merging of past scholarly work in elder care, cultural diversity and complementary and alternative medicine framed the proposed study. Restless Legs Syndrome (RLS) is a common sleep disorder affecting up to 15% of the population, especially in older adults. Quite distressing to the patients, the manifestations of RLS include irritating feelings in the legs at rest or bedtime only relieved with movement. These symptoms affect sleep onset and quality of sleep often resulting in depression, anxiety, and poor quality of life. Treatment often stops working or is discontinued due to side effects from the pharmacological agents used to treat RLS. The use of valerian as a complementary treatment may benefit persons with RLS. Valerian is a sleep aid that has been used for centuries, acting as a benzodiazepine, without the negative side effects of cognitive impairment, hangover effect, or addiction. Although placebo-controlled trials with scientific rigor are lacking, valerian has been shown to be very promising in decreasing sleep onset and improving sleep outcomes. The specific aim of this pilot study is to evaluate the effectiveness of valerian with a placebo-controlled, phase II, clinical trial using a cross-over design on sleep and outcomes of symptom severity, depression, and quality of life at baseline and six weeks in adults with RLS. The proposed pilot will compare the effectiveness of valerian in 33 subjects after 6 weeks of intervention using self-report measures and objective measures of sleep, including actigraphy, psychomotor vigilance task (PVT), and serum and urine analysis. Study outcomes are expected to provide preliminary data to support a larger randomized clinical trial of valerian on time response dosing and comparing treatment outcomes of valerian with benzodiazepines in RLS. A systematic plan (academic coursework, research training, and attendance at conferences, seminars, and colloquias) is described to obtain a biomedical sleep science background as well as knowledge in sleep medicine to launch the candidate as an independent sleep nurse researcher.