Light Therapy for PD - Dose Selection

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fatigue; Parkinson Disease; Sleep Disorder
• Intervention / Treatment: Device: SunRay Light Boxes

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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
  • California
    • Irvine, California, United States, 92697
      • UC Irvine
    • Sacramento, California, United States, 95817
      • UC Davis
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Yale University
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell
    • New York, New York, United States, 10029
      • Mount Sinai - Icahn School of Medicine
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Stony Brook, New York, United States, 11794
      • SUNY Stonybrook
    • Syracuse, New York, United States, 13210
      • SUNY Upstate
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27104
      • Wake Forest University
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Columbus, Ohio, United States, 43221
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosis of idiopathic PD as defined by the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease;
2. PD Hoehn and Yahr stage 2-4;
3. A score of 2 (mild) or above on the Sleep Problems question of the MDS-UPDRS Part 1;
4. Stable dose of all PD medications for at least 30 days prior to randomization;
5. Willingness to wear an Actiwatch and complete daily sleep logs;
6. Age 45 or above

Exclusion Criteria:

1. Atypical or secondary forms of parkinsonism;
2. 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;
3. Co-existent symptomatic restless legs syndrome (RLS) (as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS) at screening;
4. Cognitive impairment as determined by a Mini Mental State Examination score <25 at screening;
5. Presence of moderate depression defined as a Beck Depression Inventory II (BDI-II) score ≥20 at screening;
6. 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;
7. 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;
8. Ongoing or recent (within 30 days prior to screening) Cognitive Behavioral Therapy for Insomnia;
9. Use of antidepressants, unless the participant has been on a stable dose for at least 60 days prior to the screening;
10. Work hours between 10 PM and 6 AM, within 60 days prior to randomization or anticipated during the 16 weeks after screening;
11. Travel between 3 or more time zones within 45 days prior to study screening or anticipated such travel during the 16 weeks after screening;
12. Unstable or serious medical illness;
13. History of significant eye trauma or disease, retinopathy, or cataract Grade 4 that would significantly affect transmission or processing of light through either eye;
14. 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;
15. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BWLT once daily; Participants in this arm will receive bright white light therapy daily once a day (in the evening)	Device: SunRay Light Boxes; SunRay light boxes will be used to administer the light therapy.
Experimental: BWLT twice daily; Participants in this arm will receive bright white light therapy daily twice a day (morning and evening).	Device: SunRay Light Boxes; SunRay light boxes will be used to administer the light therapy.
Experimental: BWLT weekly; Participants in this arm will receive bright white light therapy once weekly (in the evening).	Device: SunRay Light Boxes; SunRay light boxes will be used to administer the light therapy.
Experimental: DRLT twice daily; Participants in this arm will receive dim red light twice daily (morning and evening).	Device: SunRay Light Boxes; SunRay light boxes will be used to administer the light therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PDSS-2	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS-16	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).	8 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Actual): November 12, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Parkinson Disease; Light therapy
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Sleep Wake Disorders
• Other Study ID Numbers: NN110 1U01NS114001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This trial will follow the NINDS policy for data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No