Parkinson's Disease Clinical Trial
Official title:
Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease
Patients with Parkinson's 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 Parkinson's disease.
The hypothesis to be examined is that ramelteon will improve the quality of sleep in patients
with Parkinson's 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.
It is well established that sleep disturbances are common in patients with neurodegenerative
disorders such as Parkinson's 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
Parkinson's 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 and/or
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 sleep/wake cycle and day/night 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.
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