Light Therapy Treatment in Parkinson's Disease Patients With Daytime Somnolence
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|ClinicalTrials.gov Identifier: NCT01338649|
Recruitment Status : Completed
First Posted : April 19, 2011
Results First Posted : September 5, 2014
Last Update Posted : September 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Sleep Disorder; Excessive Somnolence||Device: Bright Light Treatment (Sun Ray Sunbox SB-558) Device: Dim red light (Sun Ray Sunbox SB-558)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effects of Bright Light Treatment on Daytime Sleepiness and Nocturnal Sleep in Patients With Parkinson's Disease|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Active Comparator: Bright White
Exposure to bright white light treatment.
Device: Bright Light Treatment (Sun Ray Sunbox SB-558)
Bright Light Treatment (Sun Ray Sunbox SB-558) using light intensity of 10,000 lux, administered during two 1 hour periods during the day.
Other Name: Sun Ray Sunbox SB-558
Placebo Comparator: Dim red light
Exposure to dim red light treatment.
Device: Dim red light (Sun Ray Sunbox SB-558)
Dim red light box administered during two 1 hour periods during the day using
Other Name: Sun Ray Sunbox SB-558
- Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure. [ Time Frame: baseline and 4 weeks ]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.
- The Global PSQI Score and PDSS Score Will be Compared. [ Time Frame: 6 weeks ]The global PSQI and PDSS scores will be taken and compared at screening, week 4 and week 6 visits.
- Actigraphy Measures Including Total Sleep Time, Sleep Efficiency, Sleep Fragmentation Index, Frequency of Naps, and Mean Activity Level (a Measurement of Daytime Function) Will be Collected. [ Time Frame: 6 weeks ]Actigraphy measures including total sleep time, sleep efficiency, sleep fragmentation index, frequency of naps, and mean activity levelwill be completed for 3 - 2 week intervals by the subjects at home. Actigraphy measures will be collected at weeks 2, 4 and 6.
- MSLT and Polysomnograph (PSG) Testing Will be Compared. [ Time Frame: 4 weeks ]MSLT and PSG testing will take place prior to light intervention at screening 2 and post light intervention at week 4.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338649
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Aleksandar Videnovic, MD, MS||Northwestern University|