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. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Scientist Development Award - Research & Training (K01)
Project #
1K01NR009570-01A2
Application #
7262926
Study Section
National Institute of Nursing Research Initial Review Group (NRRC)
Program Officer
Mann Koepke, Kathy M
Project Start
2007-05-25
Project End
2010-04-30
Budget Start
2007-05-25
Budget End
2008-04-30
Support Year
1
Fiscal Year
2007
Total Cost
$92,287
Indirect Cost
Name
University of Pennsylvania
Department
Other Health Professions
Type
Schools of Nursing
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104