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Valerian to Improve Sleep in Patients With Parkinson's Disease
This study has been completed.
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00070928
  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

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Valerian
U.S. FDA Resources
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):

Estimated Enrollment: 80
Study Start Date: September 2000
Estimated Study Completion Date: June 2006
Detailed Description:

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 to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070928

Locations
United States, Georgia
Emory University Medical School/Wesley Woods Hospital
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Investigators
Principal Investigator: Donald L. Bliwise, PhD Emory University
  More Information

Study ID Numbers: R01 AT000611-01
Study First Received: October 9, 2003
Last Updated: July 25, 2006
ClinicalTrials.gov Identifier: NCT00070928  
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Sleep

Study placed in the following topic categories:
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Dyssomnias
Sleep Disorders
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009