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.
This is a 16-week, randomized, phase II, parallel-group, dose-selection clinical trial of LT in participants with PD and co-existing sleep disruption using a comparative selection trial design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
203
SunRay light boxes will be used to administer the light therapy.
University of Alabama
Birmingham, Alabama, United States
Parkinson's Disease Sleep Scale 2
The PDSS-2 (Parkinson's Disease Sleep Scale 2) has a total score range from 0 to 60 points. Each item on the scale is scored on a scale of 0 to 4, with higher scores indicating more severe sleep problems. The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality.
Time frame: 8 weeks
Parkinson's Fatigue Scale 16
The Parkinson's Fatigue Scale (PFS-16) is a 16-item patient-rated scale that measures the presence of fatigue and its impact on daily function in patients with Parkinson's Disease. The scale includes seven items assessing the presence of fatigue and nine items measuring its impact on daily activities. The scoring range for the PFS-16 is from 1 to 5 (range 16-80), with higher scores indicating more severe fatigue. The scale is designed to exclude cognitive and emotional features of fatigue and is used to assess levels of fatigue and measure changes in response to treatment or lifestyle changes.
Time frame: 8 weeks
Parkinson's Disease Sleep Scale 2
The PDSS-2 (Parkinson's Disease Sleep Scale 2) has a total score range from 0 to 60 points. Each item on the scale is scored on a scale of 0 to 4, with higher scores indicating more severe sleep problems. The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality.
Time frame: 8 weeks
Adherence
The secondary objective of adherence centered on frequency of use. Participants recorded light exposure duration and timing daily using a LT log. For each prescribed active treatment dose frequency (once-daily BWLT, twice-daily BWLT), a binary measure of adherence was recorded for each expected day based on whether or not they completed LT at the correct frequency. The overall percentage of those days where participants completed LT at the correct frequency were compared between the two daily BWLT treatments using a generalized linear mixed model.
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Barrow Neurological Institute
Phoenix, Arizona, United States
UC Irvine
Irvine, California, United States
UC Davis
Sacramento, California, United States
Yale University
Fairfield, Connecticut, United States
University of Miami
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
...and 15 more locations
Time frame: 8 weeks