Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462254
Status:
TERMINATED
Last Update Posted:
2010-11-11
First Post:
2007-04-16
Brief Title:
Ramelteon ROZEREM in the Treatment of Sleep Disturbances Associated With Parkinsons Disease
Sponsor:
Southern California Institute for Research and Education
Organization:
Southern California Institute for Research and Education
Study Overview
Official Title:
Ramelteon ROZEREM in the Treatment of Sleep Disturbances Associated With Parkinsons Disease
Status:
TERMINATED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study discontinued
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with Parkinsons disease represent a significant proportion of VA elderly patients Sleep disturbances and caregiver burnout association with this condition represent a significant problem In this study the investigators propose to perform an evaluation of a fixed doe of ramelteon on sleep in VA outpatients diagnosed with Parkinsons disease
The hypothesis to be examined is that ramelteon will improve the quality of sleep in patients with Parkinsons disease while indirectly improving the quality of life for the patients and caregivers The investigators further hypothesize that these changes will occur through restructuring and normalization of the sleep architecture
The hypothesis to be examined is that ramelteon will improve the quality of sleep in patients with Parkinsons disease while indirectly improving the quality of life for the patients and caregivers The investigators further hypothesize that these changes will occur through restructuring and normalization of the sleep architecture
Detailed Description:
It is well established that sleep disturbances are common in patients with neurodegenerative disorders such as Parkinsons disease Together with psychosis and other behavioral abnormalities they contribute to the stress anxiety and cognitive decline of patients caregiver burnout and depression as well as health care provider frustration The mechanisms of the sleep disturbances in these conditions are still poorly understood and no rational or effective treatments have been proposed Recent data from a study of ramelteon in the elderly showed a striking ability of this compound to improve quality of sleep disturbances in Parkinsons disease
Objectives of this study are
To examine the effects of ramelteon on the quality of sleep using sleep evaluation instruments SDQ-Sleep Disorder Questionnaire and Neuropsychiatric Inventory with Caregiver Distress NPI-D Sleep Behavior Subscale administered to the patient andor their bed partner
To examine the effects of ramelteon on daytime sleepiness and memory using Epworth Sleepiness Scale ESS and Hopkins Verbal Learning Test HVLT
To examine the effects of ramelteon on the sleepwake cycle and daynight activity patterns over a prolonged period of time 1 week using a motion logger continuous motor activity recording device and computerized data analysis
To examine the effects of ramelteon on sleep architecture in a sample of patients with confirmed sleep disturbance before and after ramelteon treatment by using polysomnography
Objectives of this study are
To examine the effects of ramelteon on the quality of sleep using sleep evaluation instruments SDQ-Sleep Disorder Questionnaire and Neuropsychiatric Inventory with Caregiver Distress NPI-D Sleep Behavior Subscale administered to the patient andor their bed partner
To examine the effects of ramelteon on daytime sleepiness and memory using Epworth Sleepiness Scale ESS and Hopkins Verbal Learning Test HVLT
To examine the effects of ramelteon on the sleepwake cycle and daynight activity patterns over a prolonged period of time 1 week using a motion logger continuous motor activity recording device and computerized data analysis
To examine the effects of ramelteon on sleep architecture in a sample of patients with confirmed sleep disturbance before and after ramelteon treatment by using polysomnography
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