Valerian to Improve Sleep in Patients With Parkinson's Disease
NCT ID: NCT00070928
Last Updated: 2006-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2000-09-30
2006-06-30
Brief Summary
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Detailed Description
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This is a 17 day study where participants will be evaluated by polysomnography on days one, two, three, sixteen and seventeen.. Polysomnographic measurements will include customary variables such as total sleep time, sleep efficiency, and sleep latency, as well as EMG measures of periodic and isolated muscle activity during sleep. Participants will be required to keep a detailed sleep log of their self reported sleep characteristics across the entire 17 study nights. Outcomes will include measures of both nocturnal sleep and waking motor function. Assessments of motor function will be made the morning immediately following Nights 3 and 17 in order to test for improvement related to improved sleep. On the morning following Night 17, participants are provided with a one-week supply of valerian in an Open Label extension. Participants are provided an additional Sleep Log for this week and asked to return the Sleep Log when they complete the Open Label phase.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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valerian
Eligibility Criteria
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Inclusion Criteria
* Willing to undergo overnight, in-lab polysomnography
* Sufficient literacy to allow completion of sleep logs
* Stable doses and timing of all Parkinsonian medications during the course of the trial
Exclusion Criteria
* Parkinsonism secondary to toxic, infectious, or other medical conditions
* History of stroke, cerebellar disease, or progressive supranuclear palsy
* History of liver or renal disease
* History of duodenal or bladder obstruction
30 Years
80 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Principal Investigators
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Donald L. Bliwise, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Medical School/Wesley Woods Hospital
Atlanta, Georgia, United States
Countries
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Other Identifiers
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