Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BWLT once daily | Experimental | Participants in this arm will receive bright white light therapy daily once a day (in the evening) |
|
| BWLT twice daily | Experimental | Participants in this arm will receive bright white light therapy daily twice a day (morning and evening). |
|
| BWLT weekly | Experimental | Participants in this arm will receive bright white light therapy once weekly (in the evening). |
|
| DRLT twice daily | Experimental | Participants in this arm will receive dim red light twice daily (morning and evening). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SunRay Light Boxes | Device | SunRay light boxes will be used to administer the light therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parkinson's Disease Sleep Scale 2 | The PDSS-2 (Parkinson's Disease Sleep Scale 2) has a total score range from 0 to 60 points. Each item on the scale is scored on a scale of 0 to 4, with higher scores indicating more severe sleep problems. 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Parkinson's Fatigue Scale 16 | The Parkinson's Fatigue Scale (PFS-16) is a 16-item patient-rated scale that measures the presence of fatigue and its impact on daily function in patients with Parkinson's Disease. The scale includes seven items assessing the presence of fatigue and nine items measuring its impact on daily activities. The scoring range for the PFS-16 is from 1 to 5 (range 16-80), with higher scores indicating more severe fatigue. The scale is designed to exclude cognitive and emotional features of fatigue and is used to assess levels of fatigue and measure changes in response to treatment or lifestyle changes. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Barrow Neurological Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17612949 | Background | 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. | |
| 17516492 | Background | 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. |
Not provided
Not provided
This trial will follow the NINDS policy for data sharing.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | BWLT Twice Daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2022 | Jan 10, 2024 |
Not provided
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.
Not provided
Not provided
Not provided
| 8 weeks |
| Parkinson's Disease Sleep Scale 2 | The PDSS-2 (Parkinson's Disease Sleep Scale 2) has a total score range from 0 to 60 points. Each item on the scale is scored on a scale of 0 to 4, with higher scores indicating more severe sleep problems. 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 |
| Adherence | The secondary objective of adherence centered on frequency of use. Participants recorded light exposure duration and timing daily using a LT log. For each prescribed active treatment dose frequency (once-daily BWLT, twice-daily BWLT), a binary measure of adherence was recorded for each expected day based on whether or not they completed LT at the correct frequency. The overall percentage of those days where participants completed LT at the correct frequency were compared between the two daily BWLT treatments using a generalized linear mixed model. | 8 weeks |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| UC Irvine | Irvine | California | 92697 | United States |
| UC Davis | Sacramento | California | 95817 | United States |
| Yale University | Fairfield | Connecticut | 06824 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| Weill Cornell | New York | New York | 10021 | United States |
| Mount Sinai - Icahn School of Medicine | New York | New York | 10029 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| SUNY Stonybrook | Stony Brook | New York | 11794 | United States |
| SUNY Upstate | Syracuse | New York | 13210 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27104 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Ohio State University | Columbus | Ohio | 43221 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| 10584776 | Background | 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. |
| 7832227 | Background | 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. |
| 28241159 | Background | 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. |
| 21312275 | Background | 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. |
| 15619463 | Background | 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. |
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.
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parkinson's Disease Sleep Scale 2 | The PDSS-2 (Parkinson's Disease Sleep Scale 2) has a total score range from 0 to 60 points. Each item on the scale is scored on a scale of 0 to 4, with higher scores indicating more severe sleep problems. The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 8 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Parkinson's Fatigue Scale 16 | The Parkinson's Fatigue Scale (PFS-16) is a 16-item patient-rated scale that measures the presence of fatigue and its impact on daily function in patients with Parkinson's Disease. The scale includes seven items assessing the presence of fatigue and nine items measuring its impact on daily activities. The scoring range for the PFS-16 is from 1 to 5 (range 16-80), with higher scores indicating more severe fatigue. The scale is designed to exclude cognitive and emotional features of fatigue and is used to assess levels of fatigue and measure changes in response to treatment or lifestyle changes. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Parkinson's Disease Sleep Scale 2 | The PDSS-2 (Parkinson's Disease Sleep Scale 2) has a total score range from 0 to 60 points. Each item on the scale is scored on a scale of 0 to 4, with higher scores indicating more severe sleep problems. The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Adherence | The secondary objective of adherence centered on frequency of use. Participants recorded light exposure duration and timing daily using a LT log. For each prescribed active treatment dose frequency (once-daily BWLT, twice-daily BWLT), a binary measure of adherence was recorded for each expected day based on whether or not they completed LT at the correct frequency. The overall percentage of those days where participants completed LT at the correct frequency were compared between the two daily BWLT treatments using a generalized linear mixed model. | While LT logs were collected for all treatment arms, the secondary analysis for adherence using the GLMM was pre-specified to only compare the two active treatment groups of once and twice-daily BWLT. This was done to provide more information on the treatment group that would be potentially selected to carry forward in a phase III efficacy trial. | Posted | Number | 95% Confidence Interval | percentage of adherence | 8 weeks |
|
Participants were monitored for AEs from the time they provide informed consent until 30 days following their completion of the study (including early termination), on average for 4 months. At that point, all ongoing AEs were followed to resolution.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 37 | 1 | 37 | 5 | 37 |
| EG001 | 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. | 0 | 39 | 0 | 39 | 7 | 39 |
| EG002 | 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. | 0 | 37 | 1 | 37 | 4 | 37 |
| EG003 | 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. | 0 | 37 | 3 | 37 | 5 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neck surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| Basal cell carcinoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dehydration | General disorders | Systematic Assessment |
| ||
| Syncope | General disorders | Systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like Illness | General disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aleksandar Videnovic, MD, Associate Professor of Neurology | Massachusetts General Hospital | 617-724-3837 | avidenovic@mgh.harvard.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 7, 2023 | Jan 10, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D012893 | Sleep Wake Disorders |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | 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. |
|
|
| 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. |
|
|
|
|