Sleep Initiation and Maintenance Disorders Clinical Trial
Official title:
Valerian for Sleep Disturbance in Healthy Older Adults
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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