Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
144 participants
INTERVENTIONAL
2020-09-11
2023-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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BWLT once daily
Participants in this arm will receive bright white light therapy daily once a day (in the evening)
SunRay Light Boxes
SunRay light boxes will be used to administer the light therapy.
BWLT twice daily
Participants in this arm will receive bright white light therapy daily twice a day (morning and evening).
SunRay Light Boxes
SunRay light boxes will be used to administer the light therapy.
BWLT weekly
Participants in this arm will receive bright white light therapy once weekly (in the evening).
SunRay Light Boxes
SunRay light boxes will be used to administer the light therapy.
DRLT twice daily
Participants in this arm will receive dim red light twice daily (morning and evening).
SunRay Light Boxes
SunRay light boxes will be used to administer the light therapy.
Interventions
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SunRay Light Boxes
SunRay light boxes will be used to administer the light therapy.
Eligibility Criteria
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Inclusion Criteria
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
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.
45 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Aleksandar Videnovic, MD
Associate Professor of Neurology
Locations
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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
Countries
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References
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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.
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.
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.
Other Identifiers
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NN110 1U01NS114001
Identifier Type: -
Identifier Source: org_study_id