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Valerian to Improve Sleep in Patients With Parkinson's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00070928
First Posted: October 13, 2003
Last Update Posted: July 26, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Polysomnographic Assessment of Alternative Treatments for Sleep Disturbance in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070928


Locations
United States, Georgia
Emory University Medical School/Wesley Woods Hospital
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Donald L. Bliwise, PhD Emory University
  More Information

ClinicalTrials.gov Identifier: NCT00070928     History of Changes
Other Study ID Numbers: R01AT000611-01 ( U.S. NIH Grant/Contract )
First Submitted: October 9, 2003
First Posted: October 13, 2003
Last Update Posted: July 26, 2006
Last Verified: July 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Sleep

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases