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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00097604 |
The purpose of this study is to examine the way valerian, an herbal sleep agent, is absorbed and distributed in the body. This study will also compare the effects of valerian after 1 week versus after 2 weeks.
Condition | Intervention | Phase |
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Sleep Initiation and Maintenance Disorders |
Drug: Valerian |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Valerian for Sleep Disturbance in Healthy Older Adults |
Estimated Enrollment: | 20 |
Study Start Date: | September 2004 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Sleep disturbances are common among the elderly and may increase the risk for depression and early mortality. Use of over-the-counter sleep aids may disrupt sleep patterns and have serious side effects. Herbal medicines have the potential to improve sleep quality. Evidence suggests that valerian may improve sleep with a low rate of side effects, but its efficacy has not been thoroughly examined in the elderly. This study will determine the effectiveness and pharmacokinetics (PK) of valerian in older adults who experience disturbances in their sleep.
This study will last 8 weeks. At the sleep clinic, participants will be randomly assigned to receive either valerian or placebo on the first night of study enrollment. Participants will have an intravenous (IV) line inserted into their arms and multiple blood draws will be taken during their sleep for PK studies. The next day, participants will be sent home for a drug wash-out period and will return after 1 week for a 3-night stay at the clinic on Nights 8, 9, and 10. On Night 8, participants will adjust to their surroundings and begin a sleep log to describe the quality of their sleep; they will continue to note observations on their sleep in the sleep log for the duration of the study. Recordings of each participant's sleeping and breathing patterns will be taken on Nights 8 and 9 to screen for sleep disorders. On Night 10, participants will again be randomly assigned to receive either valerian or placebo. After Night 10, participants will be sent home and asked to continue taking their assigned intervention nightly for 11 nights. Participants will be asked to continue their sleep logs and begin a symptom log describing insomnia symptoms. After 11 nights, participants will return for another 3-night stay at the clinic on Nights 22, 23, and 24; participants will receive either valerian or placebo. Participants will then be sent home for a 12-day drug wash-out period; participants will return to the clinic for Nights 37 and 38. Night 37 will be an adaptation night; on Night 38, participants will be given the intervention they were not yet assigned on Night 24. After Night 38, participants will be asked to go home and continue their second treatment for 11 nights; participants will come back to the sleep clinic for another 3-night stay on Nights 50, 51, and 52 for observation and PK studies. After Night 52, participants will be sent home and asked to continue their sleep and symptoms logs for two more nights, then mail the logs to study researchers for analysis.
During this study, participants will be asked to keep logs of the quality of their sleep and of the insomnia symptoms they may be experiencing. In addition to the logs, post-sleep interviews will be used to assess the quality of participants' sleep and the number of awakenings. Participants' heart and breathing rates and leg movements will be measured during their stays at the sleep clinic. Participants will also have an activity monitoring device attached to either their wrist or waist for most of the study.
Ages Eligible for Study: | 55 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | Carol A. Landis, DNSc | University of Washington, School of Nursing |
Responsible Party: | University of Washington ( Carol A. Landis, Professor ) |
Study ID Numbers: | R21 AT002108-01, 04-2201-D 01 |
Study First Received: | November 24, 2004 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00097604 History of Changes |
Health Authority: | United States: Federal Government |
Sleep Aged Valerian Complementary Therapies Medicine, Herbal |
Sleep Initiation and Maintenance Disorders Mental Disorders Valerian Dyssomnias |
Sleep Disorders Healthy Sleep Disorders, Intrinsic |
Sleep Initiation and Maintenance Disorders Mental Disorders Nervous System Diseases |
Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic |