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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04291014
Other study ID # NN110 1U01NS114001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 11, 2020
Est. completion date April 2023

Study information

Verified date December 2022
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 144
Est. completion date April 2023
Est. primary completion date November 12, 2022
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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 Design


Intervention

Device:
SunRay Light Boxes
SunRay light boxes will be used to administer the light therapy.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States University of Alabama Birmingham Alabama
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of Virginia Charlottesville Virginia
United States Northwestern University Chicago Illinois
United States University of Cincinnati Cincinnati Ohio
United States Ohio State University Columbus Ohio
United States Yale University Fairfield Connecticut
United States University of Iowa Iowa City Iowa
United States UC Irvine Irvine California
United States University of Miami Miami Florida
United States Vanderbilt University Nashville Tennessee
United States Mount Sinai - Icahn School of Medicine New York New York
United States Weill Cornell New York New York
United States University of Pennsylvania Philadelphia Pennsylvania
United States Barrow Neurological Institute Phoenix Arizona
United States University of Pittsburgh Pittsburgh Pennsylvania
United States University of Rochester Rochester New York
United States UC Davis Sacramento California
United States Washington University in St. Louis Saint Louis Missouri
United States University of Utah Salt Lake City Utah
United States SUNY Stonybrook Stony Brook New York
United States SUNY Upstate Syracuse New York
United States Wake Forest University Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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