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Official Study Title: Circadian Rhythm and Sleep/Wake Cycle in Parkinson's Disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. Patients with Excessive Daytime Somnolence
Sponsor: Parkinson Disease Foundation, American Academy of Neurology  NeurologyThe scientific study of the nervous system, especially in respect to its structure, functions, and abnormalities. Foundation
Clinicaltrials.gov ID:
Study ID:

Summary

Parkinson’s disease (PD) is very frequently associated with poor overnight sleep and daytime sleepiness. One of the known cases of poor sleep and daytime sleepiness is the impairment of the “circadian clock” (internal biological clock of a person). This cause of poor sleep has not been studied in people with PD who suffer from poor sleep and daytime sleepiness. This study is being done in order to look at the functioning of the biological clock in people with PD. The investigators will examine sleep patterns and daytime sleepiness, as well as melatonin and cortisol blood levels and clock gene  GeneUnits of heredity that are made of DNA and contained in every cell. They produce proteins that control biological development and function. function during a 24-hour period.

Thirty participants will be enrolled. Fifteen people with PD with daytime sleepiness will be matched for age, disease stage, and dopaminergic medications with 15 PD participants without excessive daytime sleepiness.  Participation in this study will last for about two weeks.  The first visit, called the screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. visit, will be completed in the Northwestern University Department of Neurology outpatient clinic. This will be followed with a 14-day baseline  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. period in which activity levels will be measured using an actiwatch and participants will complete daily sleep logs at home. After the 14-day baseline period, participants are admitted to the hospital for three consecutive nights. During the hospital stay, participants will have two overnight sleep studies and a 24-hour blood sampling for melatonin, cortisol, and clock genes.
 

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

General PD symptoms, Loss of Energy, Sleep disturbances

Time Commitment

• Less than one month
• 1 clinic visit, 3 consecutive days in hospital

Eligibility

• Minimum Age: 50
• Maximum Age: 80
• Gender(s) Accepted: Either

Inclusion Criteria

• Diagnosis of PD
• Treatment with at least one PD medication
• Stable PD medication regimen for at least 4 weeks prior to study screening
• 50-80 years old

Exclusion Criteria

• Diagnosis of Restless Leg Syndrome (RLS), Obstructive Sleep Apnea (OSA), or REM behavior disorder (RBD)
• Cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. impairment
• Untreated hallucinations
• Use of sleep medications
• Presence of depression
• Current diagnosis or history of drug or alcohol abuse
• High daily caffeine intake
• Travel through 2 time zones within 90 days prior to study screening

Enrollment

Expected Enrollment: 30 (US)
Date Enrollment Began: Nov 2008
Date Enrollment Ends: Jul 2011
Last Updated Date: Apr 22 2010
Trial Post Date: Apr 23 2009
Website: http://www.parkinsons.northwestern.edu/research.html

Primary Contacts and Locations

Illinois

• Angelica Marconi
  Northwestern University
  a-marconi@northwestern.edu
  Phone: (312) 503-1999
  675 N. St. Clair, 20-100
  Chicago, IL 60611
  USA
  
• Aleksandar Videnovic, MD
  Northwestern University
  avidenov@nmff.org
  675 N. St. Clair, 20-100
  Chicago, IL 60611
  USA