• PDtrials - Parkinson's Disease Clinical Trials
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Official Study Title: Light Therapy  TherapyAnother word for “treatment”. for Daytime Sleepiness in Parkinson’s Disease
Sponsor: National Parkinson Foundation
Clinicaltrials.gov ID: NCT01338649
Study ID:

Summary

Parkinson’s disease (PD) is very frequently associated with poor overnight sleep and daytime sleepiness. Humans have a regular internal sleep/wake cycle that keeps us awake and keeps our sleep time on track. Being exposed to bright light or bright light therapy has been shown to improve the sleep/wake cycle in people with sleep problems as well as in people with Alzheimer’s disease.  Exposure to bright light also helps shift workers and people with jet lag from flying through different time zones.

This study is being done to look at the effects that exposure to a bright light has on daytime sleepiness and night-time sleep in Parkinson’s disease. About 30 people with Parkinson’s disease and sleep problems will be in this study. Bright light therapy involves sitting in front of a light box for 1 to 1. 5 hours several times a day for a few weeks. There is interest in identifying which colors of light are the most efficient for light therapy treatment. The most commonly used are bright white and red lights.

Three clinic visits (approximately 1 hour each) and two 24-hour stays (including sleep studies) are involved in this study. There are also three 14-day periods in between the clinic visits where activity levels will be measured using an actiwatch, a small, watch-like device that measures movement throughout the day and night, and participants will complete daily sleep logs at home. During one of the 14-day periods, participants will use the light box as instructed at home.

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 six months
• Three clinic visits, two 24-hour stays in the hospital.

Eligibility

• Gender(s) Accepted: Either

Inclusion Criteria

• Diagnosis of PD
• Excessive daytime sleepiness
• Stable PD medication for at least four weeks prior to study screening

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
• Current diagnosis or history of drug or alcohol abuse
• High daily caffeine intake
• Travel through two time zones within 90 days prior to study screening
• Significant cataracts, narrow angle glaucoma or blindness

Enrollment

Expected Enrollment: 30 (US)
Date Enrollment Began: Nov 2007
Date Enrollment Ends:
Last Updated Date: Jun 23 2011
Trial Post Date: May 18 2010
Website: http://www.parkinsons.northwestern.edu/clinical_trials.html

Primary Contacts and Locations

Illinois

• Aleksandar Videnovic, M.D.
  Northwestern University 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. and Movement Disorders Center
  675 N. St. Clair, 20-100
  Chicago, IL 60611
  USA
  
• Laura Wulf
  Northwestern University Parkinson's Disease and Movement Disorders Center
  l-wulf@northwestern.edu
  Phone: (312) 503-1999
  675 N. St. Clair, 20-100
  Chicago, IL 60611
  USA