An interventional study of Bright Light Treatment (Sun Ray Sunbox SB-558) and Dim red light (Sun Ray Sunbox SB-558) in Parkinson's Disease and Sleep Disorder; Excessive Somnolence, sponsored by Northwestern University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 27 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Exposure to bright white light treatment.
Device: Bright Light Treatment (Sun Ray Sunbox SB-558)
Exposure to dim red light treatment.
Device: Dim red light (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.
Also known as: Sun Ray Sunbox SB-558
Dim red light box administered during two 1 hour periods during the day using
Also known as: Sun Ray Sunbox SB-558
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.
Time frame: baseline and 4 weeks
| Milestone | Bright White | Dim Red Light |
|---|---|---|
| Started | 13 | 14 |
| Completed | 13 | 14 |
| Not completed | 0 | 0 |
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.
| score | Bright White | Dim Red Light |
|---|---|---|
| Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure. | 4.46 ± 2.54 | 1.77 ± 3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bright White | — | 0/13 (0%) | 2/13 (15.4%) |
| Dim Red Light | — | 0/14 (0%) | 1/14 (7.1%) |
| Event | Bright White | Dim Red Light |
|---|---|---|
| headacheNervous system disorders | 1/13 | 0/14 |
| sleepinessNervous system disorders | 1/13 | 0/14 |
| itchy eyesEye disorders | 0/13 | 1/14 |
| Age, Continuous(years) | Bright White | Dim Red Light | Total |
|---|---|---|---|
| Mean | 67 ± 6.9 | 59.3 ± 11.3 | 63.6 ± 9.9 |
| Sex: Female, Male(Participants) | Bright White | Dim Red Light | Total |
|---|---|---|---|
| Female | 9 | 8 | 17 |
| Male | 4 | 6 | 10 |
| Region of Enrollment(participants) | Bright White | Dim Red Light | Total |
|---|---|---|---|
| United States | 13 | 14 | 27 |
The record gives a start of Nov 2007, a primary completion of Oct 2012 and a completion of Oct 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2014, 1 year 11 months after primary completion.
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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