Effects of Valerian on Sleep in Healthy Older Adults

Completed · Phase 2 · Has a placebo group

Conditions studied: Sleep Initiation and Maintenance Disorders

In brief

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.

Key facts

Study ID

NCT00097604

Run by

University of Washington

People needed

18

Starts

2004-09-01

Expected to finish

2008-04-01

Last updated by the study team

2010-07-29

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Pittsburgh Sleep Quality Instrument score higher than 5
• Insomnia Severity Index score less than 22
• At least 5 years past menopause, for female participants

You may not qualify if…

• Current use of prescribed or over-the-counter sleep medications
• Plans to move from the area within 2 months of study entry
• Significant signs and symptoms of sleep apnea; periodic leg movements in sleep (PLMS) associated with arousals; rapid eye movement (REM) behavior disorder; restless legs syndrome; advanced sleep phase syndrome; delayed sleep phase syndrome; or any other sleep disorder, including severe insomnia or a history of chronic insomnia, for which standard therapy would be the treatment of choice
• Shift work within 6 months prior to study entry
• Current unusual or highly unstable sleep schedule
• Trans-meridian travel across more than three time zones within 4 weeks prior to study entry
• Body mass index between 18 kg/m2 and 32 kg/m2
• Significant and uncontrolled major illness or psychiatric disease
• Cognitive impairment
• Current life stress
• Use of tobacco within 6 months prior to study entry
• Excessive use of alcohol or caffeine
• Currently taking hormone replacement therapy hypnotic or psychotropic medication

Where it is running

• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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