Valerian to Improve Sleep in Patients With Parkinson's Disease
This study is currently recruiting patients.
Verified by National Center for Complementary and Alternative Medicine (NCCAM) November 2004
Purpose
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).
| Condition |
Intervention |
Phase |
Insomnia
Parkinson's Disease
|
Drug: valerian
|
Phase II
|
MedlinePlus related topics: Parkinson's Disease; Sleep Disorders
Genetics Home Reference related topics: Parkinson disease
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Polysomnographic Assessment of Alternative Treatments for Sleep Disturbance in Parkinson's Disease
Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):
Expected Total Enrollment: 80
Patients with PD have exceptionally poor sleep. Sleep in patients with PD is characterized by excessive activity in surface electromyographic (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 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.
Eligibility
Ages Eligible for Study: 30 Years - 80 Years, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00070928
Georgia Emory University Medical School/Wesley Woods Hospital, Atlanta, Georgia, 30329, United States; Recruiting
Study chairs or principal investigators
Donald L. Bliwise, PhD, Principal Investigator, Emory University
More Information
Study ID Numbers: 1 R01 AT00611-01
Last Updated: December 8, 2005
Record first received: October 9, 2003
ClinicalTrials.gov Identifier:
NCT00070928Health Authority: United States: Federal Government
