Light Therapy for PD - Dose Selection

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04291014
• Other study ID #: NN110 1U01NS114001
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Fatigue
• Parkinson Disease
• Sleep Disorder
• Sleep Wake Disorders

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