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| Name | Class |
|---|---|
| National Parkinson Foundation | OTHER |
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Study objectives are to determine the efficacy, safety and tolerability of bright light treatment in Parkinson's Disease (PD) patients with daytime sleepiness. Thirty PD patients will be enrolled and equally randomized to bright light or dim-red light treatment. Objective (actigraphy) and subjective (sleep logs/scales) sleep measures will be collected through the baseline and intervention phases of the study. The primary outcome measure will be the change in the Epworth Sleepiness Scale (ESS) comparing the bright light treatment with dim-red light treatment. Secondary outcome measures will include the Multiple Sleep Latency Test (MSLT), global Pittsburgh Sleep Quality Index (PSQI) score, Parkinson's Disease Sleep Scale (PDSS) score, and actigraphy measures. A variety of exploratory analyses will examine the effects of bright light treatment on fatigue, depression, quality of life, cognition, and motor disability.
Hypothesis: Bright light exposure will diminish daytime sleepiness and improve night-time sleep in PD patients with daytime sleepiness.
See above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright White | Active Comparator | Exposure to bright white light treatment. |
|
| Dim red light | Placebo Comparator | Exposure to dim red light treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright Light Treatment (Sun Ray Sunbox SB-558) | Device | Bright Light Treatment (Sun Ray Sunbox SB-558) using light intensity of 10,000 lux, administered during two 1 hour periods during the day. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure. | ESS score range is 0-24; lower ESS scores indicate less daytime sleepiness; higher ESS scores indicate more severe sleepiness ESS will be taken and compared at screening and week 4 visits between the bright light exposure and dim-red light exposure groups. | baseline and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aleksandar Videnovic, MD, MS | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3233589 | Background | Lees AJ, Blackburn NA, Campbell VL. The nighttime problems of Parkinson's disease. Clin Neuropharmacol. 1988 Dec;11(6):512-9. doi: 10.1097/00002826-198812000-00004. | |
| 9827612 | Background | Tandberg E, Larsen JP, Karlsen K. A community-based study of sleep disorders in patients with Parkinson's disease. Mov Disord. 1998 Nov;13(6):895-9. doi: 10.1002/mds.870130606. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bright White | Bright white light treatment group. Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day. |
| FG001 | Dim Red Light | Dim red light control group. Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bright White | Bright white light treatment group. Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day. |
| BG001 | Dim Red Light |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure. | ESS score range is 0-24; lower ESS scores indicate less daytime sleepiness; higher ESS scores indicate more severe sleepiness ESS will be taken and compared at screening and week 4 visits between the bright light exposure and dim-red light exposure groups. | Posted | Mean | Standard Deviation | score | baseline and 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bright White | Bright white light treatment group. Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aleksandar Videnovic | Massachusetts General Hospital | 855-644-6387 | avidenovic@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D012893 | Sleep Wake Disorders |
| D006970 | Disorders of Excessive Somnolence |
| D000077260 | Sleepiness |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Dim red light (Sun Ray Sunbox SB-558) | Device | Dim red light box administered during two 1 hour periods during the day using |
|
|
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| 28241159 | Derived | 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. |
Dim red light control group. Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | number of participants | Number | participants |
|
|
|
|
| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | Dim Red Light | Dim red light control group. Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using | 0 | 14 | 1 | 14 |
| sleepiness | Nervous system disorders | Systematic Assessment |
|
| itchy eyes | Eye disorders | Systematic Assessment |
|
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| 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 |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |