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Valerian to Improve Sleep in Patients With Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00070928
First received: October 9, 2003
Last updated: July 25, 2006
Last verified: July 2006
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on October 20, 2014