Light Therapy for PD - Dose Selection

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04291014
• Collaborator: (none)
• Enrollment: 144
• Locations: 25
• Arms: 4
• Anticipated Duration (Months): 30.6
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Sleep Disorder; Fatigue	Device: SunRay Light Boxes	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model 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.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.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Dose Selection Trial of Light Therapy for Impaired Sleep in Parkinson's Disease
• Actual Study Start Date: Sep 11, 2020
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35233
2	Barrow Neurological Institute	Phoenix	Arizona	United States	85013
3	UC Irvine	Irvine	California	United States	92697
4	UC Davis	Sacramento	California	United States	95817
5	Yale University	Fairfield	Connecticut	United States	06824
6	University of Miami	Miami	Florida	United States	33136
7	Northwestern University	Chicago	Illinois	United States	60611
8	University of Iowa	Iowa City	Iowa	United States	52242
9	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
10	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
11	University of Michigan	Ann Arbor	Michigan	United States	48109
12	Washington University in St. Louis	Saint Louis	Missouri	United States	63110
13	Weill Cornell	New York	New York	United States	10021
14	Mount Sinai - Icahn School of Medicine	New York	New York	United States	10029
15	University of Rochester	Rochester	New York	United States	14642
16	SUNY Stonybrook	Stony Brook	New York	United States	11794
17	SUNY Upstate	Syracuse	New York	United States	13210
18	Wake Forest University	Winston-Salem	North Carolina	United States	27104
19	University of Cincinnati	Cincinnati	Ohio	United States	45219
20	Ohio State University	Columbus	Ohio	United States	43221
21	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19107
22	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
23	Vanderbilt University	Nashville	Tennessee	United States	37232
24	University of Utah	Salt Lake City	Utah	United States	84132
25	University of Virginia	Charlottesville	Virginia	United States	22903

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Brown RG, Dittner A, Findley L, Wessely SC. The Parkinson fatigue scale. Parkinsonism Relat Disord. 2005 Jan;11(1):49-55.
• Gallin PF, Terman M, Remé 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.
• Paus S, Schmitz-Hübsch T, Wüllner 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.
• Trenkwalder C, Kohnen R, Högl B, Metta V, Sixel-Döring F, Frauscher B, Hülsmann 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.
• 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.
• 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.

• Responsible Party: Aleksandar Videnovic, MD, Associate Professor of Neurology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04291014
• Other Study ID Numbers: NN110 1U01NS114001
• First Posted: Mar 2, 2020
• Last Update Posted: May 5, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aleksandar Videnovic, MD, Associate Professor of Neurology, Massachusetts General Hospital: Parkinson Disease; Light therapy
• Additional relevant MeSH terms: Parkinson Disease; Sleep Wake Disorders

Study Results

No Results Posted as of May 5, 2021