Effects of Valerian on Sleep in Healthy Older Adults
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Valerian root extract
Intervention type(s): Dietary Supplement
Intervention description(s): Valerian root extract, 100 mg softgels, 3 softgels each night for 2 weeks, 30 minutes before bedtime
Other intervention name(s): Valerian
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep; Aged; Valerian; Complementary Therapies; Medicine, Herbal