Valerian to Improve Sleep in Patients With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Polysomnographic Assessment of Alternative Treatments for Sleep Disturbance in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00070928
• Other study ID #: R01AT000611-01
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2003
• Last updated: July 25, 2006
• Start date: September 2000
• Est. completion date: June 2006

Study information

• Verified date: July 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• valerian

Locations

Country	Name	City	State
United States	Emory University Medical School/Wesley Woods Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,