Light Therapy for PD - Dose Selection

Completed · Not applicable

Conditions studied: Parkinson Disease, Sleep Disorder, Fatigue

In brief

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.

Key facts

Study ID

NCT04291014

Run by

Massachusetts General Hospital

People needed

203

Starts

2020-09-11

Expected to finish

2023-01-10

Last updated by the study team

2026-03-05

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• 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
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Weill Cornell — New York, New York, United States
• Mount Sinai - Icahn School of Medicine — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• SUNY Stonybrook — Stony Brook, New York, United States
• SUNY Upstate — Syracuse, New York, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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