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Valerian to Improve Sleep in Patients With Parkinson's Disease

Sponsor
National Center for Complementary and Integrative Health (NCCIH) (NIH)
Overall Status
Completed
CT.gov ID
NCT00070928
Collaborator
(none)
80
Enrollment
1
Location
69
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
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
Study Start Date :
Sep 1, 2000
Study Completion Date :
Jun 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00070928
    Other Study ID Numbers:
    • R01AT000611-01
    First Posted:
    Oct 13, 2003
    Last Update Posted:
    Jul 26, 2006
    Last Verified:
    Jul 1, 2006
    Keywords provided by , ,
    Sleep
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Jul 26, 2006