Valerian to Improve Sleep in Patients With Parkinson's Disease
Primary Purpose
Insomnia, Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
valerian
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Sleep
Eligibility 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
Sites / Locations
- Emory University Medical School/Wesley Woods Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00070928
First Posted
October 9, 2003
Last Updated
July 25, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00070928
Brief Title
Valerian to Improve Sleep in Patients With Parkinson's Disease
Official Title
Polysomnographic Assessment of Alternative Treatments for Sleep Disturbance in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Parkinson's Disease
Keywords
Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valerian
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald L. Bliwise, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Medical School/Wesley Woods Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
12. IPD Sharing Statement
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Valerian to Improve Sleep in Patients With Parkinson's Disease
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