A Dose Selection Trial of Light Therapy for Impaired Sleep in Parkinson's Disease

Status: Unknown
Location: See all (25) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to determine the most effective dose of light therapy to improve sleep in people with Parkinson's Disease. Four groups of participants will receive bright-white or dim-red light therapy at different times throughout the day.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• Diagnosis of idiopathic PD as defined by the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease;

• PD Hoehn and Yahr stage 2-4;

• A score of 2 (mild) or above on the Sleep Problems question of the MDS-UPDRS Part 1;

• Stable dose of all PD medications for at least 30 days prior to randomization;

• Willingness to wear an Actiwatch and complete daily sleep logs;

• Age 45 or above

Locations
United States
Alabama
University of Alabama
Birmingham
Arizona
Barrow Neurological Institute
Phoenix
California
UC Irvine
Irvine
UC Davis
Sacramento
Connecticut
Yale University
Fairfield
Florida
University of Miami
Miami
Iowa
University of Iowa
Iowa City
Illinois
Northwestern University
Chicago
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Massachusetts General Hospital
Boston
Michigan
University of Michigan
Ann Arbor
Missouri
Washington University in St. Louis
Saint Louis
North Carolina
Wake Forest University
Winston-salem
New York
Mount Sinai - Icahn School of Medicine
New York
Weill Cornell
New York
University of Rochester
Rochester
SUNY Stonybrook
Stony Brook
SUNY Upstate
Syracuse
Ohio
University of Cincinnati
Cincinnati
Ohio State University
Columbus
Pennsylvania
University of Pennsylvania
Philadelphia
University of Pittsburgh
Pittsburgh
Tennessee
Vanderbilt University
Nashville
Utah
University of Utah
Salt Lake City
Virginia
University of Virginia
Charlottesville
Time Frame
Start Date: 2020-09-11
Completion Date: 2023-04
Participants
Target number of participants: 144
Treatments
Experimental: BWLT once daily
Participants in this arm will receive bright white light therapy daily once a day (in the evening)
Experimental: BWLT twice daily
Participants in this arm will receive bright white light therapy daily twice a day (morning and evening).
Experimental: BWLT weekly
Participants in this arm will receive bright white light therapy once weekly (in the evening).
Experimental: DRLT twice daily
Participants in this arm will receive dim red light twice daily (morning and evening).
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov