Status:
COMPLETED
Effects of Valerian on Sleep in Healthy Older Adults
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
55-80 years
Phase:
PHASE2
Brief 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...
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 effect...
Eligibility Criteria
Inclusion
- Pittsburgh Sleep Quality Instrument score higher than 5
- Insomnia Severity Index score less than 22
- At least 5 years past menopause, for female participants
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00097604
Start Date
September 1 2004
End Date
April 1 2008
Last Update
July 29 2010
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195