| Polysomnographic
Assessments of Alternative Treatments for Sleep Disturbances in Parkinson's
Disease
Principal
Investigator
Donald L. Bliwise, Ph.D.
- Dr. Bliwise is responsible for overseeing the clinical trial. He has
25 years experience in the polysomnographic recording of human sleep including
patients with a variety of neurodegenerative conditions such as Alzheimer's
and Parkinson's Disease. Dr. Bliwise has also been involved in numerous
clinical trials of sleep medications.
Co-Principal
Investigators
Dr. David B. Rye, M.D.
- Dr. Rye is responsible for providing the medical supervision and back-up
for patients in the clinical trial, as well as for assisting Dr. Decker
with issues related to utilization of medication for the study subjects.
He is a Board certified neurologist and sleep medicine specialist with
extensive clinical experience in the management of sleep problems in patients
with movement disorders.
Dr. Michael
J. Decker, Ph.D. - Dr. Decker is responsible for the day-to-day management
of the study including recruitment, scheduling, analyses, medication dispensing,
and monitoring of group assignments. He has extensive experience in monitoring
and recording sleep in ambulatory settings and a background in nursing
and respiratory therapy.
Background
Patients with Parkinson's Disease (PD) have exceptionally poor sleep,
which is most notably characterized by excessive activity in surface electomyographic
(EMG) recordings from many different muscle groups. Despite this disturbance,
approximately 50% of PD patients note that, on nights when they are able
to achieve sleep, they experience a transient (1-3 hour) reduction in
waking motor symptoms upon arising in the morning. This effect has been
termed Sleep Benefit. The results of this study will represent the first
data applying rigorous clinical trial methodology to the study of disturbed
sleep in PD patients and will critically examine the efficacy of a substance
with widespread, over-the-counter use for which little polysomnographic
data currently exist.
Study
This is a randomized, double-blind, placebo-controlled polysomnographic
clinical trial that will assess the use of valerian for the treatment
of sleep disturbance in PD. The study will be conducted for 17 consecutive
nights (3 baseline, 14 drug) using state-of-the-art digitized ambulatory
polysomnography in Emory Univeristy's General Clinical Research Center.
Outcomes will include both measures of nocturnal sleep and waking motor
function. 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.
Assessments of motor function will be made the morning immediately following
the third baseline night and the third drug night in order to test for
improvement related to improved sleep.
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