Light Therapy for PD - Dose Selection

NCT04291014 | Completed Results

• 1 other identifier: NN110 1U01NS114001
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 25

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.

Conditions

Parkinson Disease; Sleep Disorder; Fatigue

Keywords

Parkinson Disease; Light therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (3)

• Parkinson's Fatigue Scale 16

  8 weeks

• Parkinson's Disease Sleep Scale 2

  8 weeks

• Adherence

  8 weeks

Study Arms (4)

BWLT once daily

EXPERIMENTAL

Participants in this arm will receive bright white light therapy daily once a day (in the evening)

Device: SunRay Light Boxes

BWLT twice daily

EXPERIMENTAL

Participants in this arm will receive bright white light therapy daily twice a day (morning and evening).

Device: SunRay Light Boxes

BWLT weekly

EXPERIMENTAL

Participants in this arm will receive bright white light therapy once weekly (in the evening).

Device: SunRay Light Boxes

DRLT twice daily

EXPERIMENTAL

Participants in this arm will receive dim red light twice daily (morning and evening).

Device: SunRay Light Boxes

Interventions

SunRay Light Boxes DEVICE

SunRay light boxes will be used to administer the light therapy.

BWLT once daily; BWLT twice daily; BWLT weekly; DRLT twice daily

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (25)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

UC Irvine

Irvine, California, 92697, United States

Location

UC Davis

Sacramento, California, 95817, United States

Location

Yale University

Fairfield, Connecticut, 06824, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Weill Cornell

New York, New York, 10021, United States

Location

Mount Sinai - Icahn School of Medicine

New York, New York, 10029, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

SUNY Stonybrook

Stony Brook, New York, 11794, United States

Location

SUNY Upstate

Syracuse, New York, 13210, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27104, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Ohio State University

Columbus, Ohio, 43221, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (7)

• Willis GL, Turner EJ. Primary and secondary features of Parkinson's disease improve with strategic exposure to bright light: a case series study. Chronobiol Int. 2007;24(3):521-37. doi: 10.1080/07420520701420717.

  PMID: 17612949 BACKGROUND

• Paus S, Schmitz-Hubsch T, Wullner U, Vogel A, Klockgether T, Abele M. Bright light therapy in Parkinson's disease: a pilot study. Mov Disord. 2007 Jul 30;22(10):1495-1498. doi: 10.1002/mds.21542.

  PMID: 17516492 BACKGROUND

• Terman M, Terman JS. Bright light therapy: side effects and benefits across the symptom spectrum. J Clin Psychiatry. 1999 Nov;60(11):799-808; quiz 809.

  PMID: 10584776 BACKGROUND

• Gallin PF, Terman M, Reme CE, Rafferty B, Terman JS, Burde RM. Ophthalmologic examination of patients with seasonal affective disorder, before and after bright light therapy. Am J Ophthalmol. 1995 Feb;119(2):202-10. doi: 10.1016/s0002-9394(14)73874-7.

  PMID: 7832227 BACKGROUND

• Videnovic A, Klerman EB, Wang W, Marconi A, Kuhta T, Zee PC. Timed Light Therapy for Sleep and Daytime Sleepiness Associated With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2017 Apr 1;74(4):411-418. doi: 10.1001/jamaneurol.2016.5192.

  PMID: 28241159 BACKGROUND

• Trenkwalder C, Kohnen R, Hogl B, Metta V, Sixel-Doring F, Frauscher B, Hulsmann J, Martinez-Martin P, Chaudhuri KR. Parkinson's disease sleep scale--validation of the revised version PDSS-2. Mov Disord. 2011 Mar;26(4):644-52. doi: 10.1002/mds.23476. Epub 2011 Feb 10.

  PMID: 21312275 BACKGROUND

• Brown RG, Dittner A, Findley L, Wessely SC. The Parkinson fatigue scale. Parkinsonism Relat Disord. 2005 Jan;11(1):49-55. doi: 10.1016/j.parkreldis.2004.07.007.

  PMID: 15619463 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Sleep Wake Disorders; Fatigue

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Aleksandar Videnovic, MD, Associate Professor of Neurology
• Organization: Massachusetts General Hospital

avidenovic@mgh.harvard.edu

617-724-3837

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Model Details: 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 Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: September 11, 2020
• Primary Completion: November 12, 2022
• Study Completion: January 10, 2023
• Last Updated: March 5, 2026
• Results First Posted: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)