Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070928
Status:
COMPLETED
Last Update Posted:
2006-07-26
First Post:
2003-10-09
Brief Title:
Valerian to Improve Sleep in Patients With Parkinsons Disease
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Polysomnographic Assessment of Alternative Treatments for Sleep Disturbance in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None