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Home > "V" Clinical Trials Conditions > Valerian to Improve Sleep in Patients with Parkinson's Disease  Valerian to Improve Sleep in Patients with Parkinson's Disease
Valerian to Improve Sleep in Patients with Parkinson's Disease
For Condition: Insomnia,Parkinson's Disease
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: The purpose of this trial is to test the short-term effectiveness of valerian, a medicinal herb, to improve sleep in patients with Parkinson's disease (PD).
Details: Patients with PD have exceptionally poor sleep. Sleep in patients with PD is characterized by excessive activity in surface electomyographic (EMG) recordings from many different muscle groups. Despite sleep disturbances, approximately 50% of patients experience a transient (1 to 3 hour) reduction in waking motor symptoms upon arising in the morning. This effect has been termed Sleep Benefit. This study will evaluate the effects of valerian, a medicinal herb, on the sleep of patients with PD. 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 valarian 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 30 Years/80 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Idiopathic Parkinson’s disease - 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 - Dementia - 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
Total Enrollment: 80
Location and Contact Information:
Overall Study Official:
DonaldBliwise, Principal Investigator, Emory University
Emory University Medical School/Wesley Woods Hospital *Recruiting*
Atlanta, Georgia, 30329
United States
Recruiting Laura-Beth Straight 404-728-4750
Additional Information:
Study ID Numbers: 1 R01 AT00611-01;
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070928
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Valerian to Improve Sleep in Patients with Parkinson's Disease
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