Light Therapy for PD - Dose Selection
- Conditions
- Sleep DisorderParkinson DiseaseFatigue
- Interventions
- Device: SunRay Light Boxes
- Registration Number
- NCT04291014
- Lead Sponsor
- Massachusetts General Hospital
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 144
- 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
- Atypical or secondary forms of parkinsonism;
- Co-existent significant sleep apnea at screening, as determined by the PI's clinical assessment; adequately treated sleep apnea, as assessed by sleep apnea machine download (CPAP download) will be permitted;
- Co-existent symptomatic restless legs syndrome (RLS) (as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS) at screening;
- Cognitive impairment as determined by a Mini Mental State Examination score <25 at screening;
- Presence of moderate depression defined as a Beck Depression Inventory II (BDI-II) score ≥20 at screening;
- Current untreated hallucinations or psychosis (drug-induced or spontaneous) with a score of 2 or above on the Hallucinations and Psychosis question of the MDS-UPDRS Part 2;
- Use of hypno-sedative drugs for sleep or stimulants, unless the participant has been on a stable dose for at least 60 days prior to the screening;
- Ongoing or recent (within 30 days prior to screening) Cognitive Behavioral Therapy for Insomnia;
- Use of antidepressants, unless the participant has been on a stable dose for at least 60 days prior to the screening;
- Work hours between 10 PM and 6 AM, within 60 days prior to randomization or anticipated during the 16 weeks after screening;
- Travel between 3 or more time zones within 45 days prior to study screening or anticipated such travel during the 16 weeks after screening;
- Unstable or serious medical illness;
- History of significant eye trauma or disease, retinopathy, or cataract Grade 4 that would significantly affect transmission or processing of light through either eye;
- Current use, use at any time during study participation, or use within the 30 days prior to screening of photosensitizing or other medications that in the opinion of the investigator would interfere with the safety of the participant during the trial, including: amiodarone, porfimer, psoralens, chlorpromazine, quinidine, demeclocycline, temoporfin, tetracycline, fleroxacin, oral isoretinoin, voriconazole, nalidixic acid, thioridazine, St. John's wort, ofloxacin, and piroxicam;
- Pregnant women will be excluded from participation; if a participant is pre-menopausal, a urine pregnancy test will be conducted at randomization to determine eligibility.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BWLT twice daily SunRay Light Boxes Participants in this arm will receive bright white light therapy daily twice a day (morning and evening). BWLT weekly SunRay Light Boxes Participants in this arm will receive bright white light therapy once weekly (in the evening). DRLT twice daily SunRay Light Boxes Participants in this arm will receive dim red light twice daily (morning and evening). BWLT once daily SunRay Light Boxes Participants in this arm will receive bright white light therapy daily once a day (in the evening)
- Primary Outcome Measures
Name Time Method PDSS-2 8 weeks The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality.
- Secondary Outcome Measures
Name Time Method PFS-16 8 weeks The PFS-16 is a patient-rated scale that measures fatigue. The scale allows the measurements of the presence of fatigue (seven items) and its impact on daily function (nine items).
Trial Locations
- Locations (25)
University of Iowa
🇺🇸Iowa City, Iowa, United States
Weill Cornell
🇺🇸New York, New York, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Mount Sinai - Icahn School of Medicine
🇺🇸New York, New York, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
UC Irvine
🇺🇸Irvine, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Miami
🇺🇸Miami, Florida, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
SUNY Stonybrook
🇺🇸Stony Brook, New York, United States
SUNY Upstate
🇺🇸Syracuse, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Yale University
🇺🇸Fairfield, Connecticut, United States
University of Rochester
🇺🇸Rochester, New York, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
UC Davis
🇺🇸Sacramento, California, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States