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BLUE LIGHT THERAPY FOR SLEEP IMPAIRMENTIN PARKINSON’S DISEASE

Recruiting
Conditions
Parkinson's Disease, sleep, light therapyZiekte van Parkinson, slaap, lichttherapie
Registration Number
NL-OMON20179
Lead Sponsor
Radboud University Medical Centre Nijmegen
Brief Summary

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Journal of sleep research. 2000;9(4):373-379.<br> 12. Czeisler CA, Allan JS, Strogatz SH, et al. Bright light resets the human circadian pacemaker independent of the timing of the sleep-wake cycle. Science (New York, NY). 1986;233(4764):667-671.<br> 13. Wever RA, Polasek J, Wildgruber CM. Bright light affects human circadian rhythms. Pflugers Archiv : European journal of physiology. 1983;396(1):85-87.<br> 14. Cai Y, Liu S, Sothern RB, Xu S, Chan P. Expression of clock genes Per1 and Bmal1 in total leukocytes in health and Parkinson's disease. European journal of neurology. 2010;17(4):550-554.<br> 15. Breen DP, Vuono R, Nawarathna U, et al. Sleep and circadian rhythm regulation in early Parkinson disease. JAMA neurology. 2014;71(5):589-595.<br> 16. Mattam U, Jagota A. Daily rhythms of serotonin metabolism and the expression of clock genes in suprachiasmatic nucleus of rotenone-induced Parkinson's disease male Wistar rat model and effect of melatonin administration. 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Blue-enriched white light in the workplace improves self-reported alertness, performance and sleep quality. Scandinavian journal of work, environment & health. 2008;34(4):297-306.<br> 27. Rahman SA, Flynn-Evans EE, Aeschbach D, Brainard GC, Czeisler CA, Lockley SW. Diurnal spectral sensitivity of the acute alerting effects of light. Sleep. 2014;37(2):271-281.<br> 28. Vandewalle G, Gais S, Schabus M, et al. Wavelength-dependent modulation of brain responses to a working memory task by daytime light exposure. Cerebral cortex (New York, NY : 1991). 2007;17(12):2788-2795.<br> 29. Vandewalle G, Schmidt C, Albouy G, et al. Brain responses to violet, blue, and green monochromatic light exposures in humans: prominent role of blue light and the brainstem. PloS one. 2007;2(11):e1247.<br> 30. Daneault V, Hebert M, Albouy G, et al. Aging reduces the stimulating effect of blue light on cognitive brain functions. Sleep. 2014;37(1):85-96.<br> 31. Daneault V, Dumont M, Masse E, Vandewalle G, Carrier J. Light-sensitive brain pathways and aging. Journal of physiological anthropology. 2016;35:9.<br> 32. Roecklein KA, Wong PM, Miller MA, Donofry SD, Kamarck ML, Brainard GC. Melanopsin, photosensitive ganglion cells, and seasonal affective disorder. Neuroscience and biobehavioral reviews. 2013;37(3):229-239.<br> 33. 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 neurology. 2017;74(4):411-418.<br> 34. Artemenko AR, Levin Ia I. [The phototherapy of parkinsonism patients]. Zhurnal nevrologii i psikhiatrii imeni SS Korsakova. 1996;96(3):63-66.<br> 35. Buysse DJ, Reynolds CF, 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry research. 1989;28(2):193-213.<br> 36. Post B, Merkus MP, de Bie RM, de Haan RJ, Speelman JD. 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Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

Male or female subjects diagnosed with idiopathic PD according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria with Hoehn & Yahr stage 2-4

- Ability to obtain written inform consent (IC) for participation in the study

Exclusion Criteria

- Atypical Parkinsonism (Subjects with Parkinsonian features caused by disorder such as multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies or multiple brain infarcts)

- Severity of Parkinson’s disease defined as stage 1 or 5 according to Hoehn & Yahr stages

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome of this study will be the change in Pittsburgh Sleep Quality Index score (PSQI).<br>
Secondary Outcome Measures
NameTimeMethod
The following parameter will serve as secondary outcome measures:<br /><br>a.Motor Symptoms measurements: <br /><br>-The MDS-Unified Parkinson’s Disease Rating scale (MDS-UPDRS) parts I-IV<br /><br>b.Non- motor symptoms measurements: <br /><br>-Sleep impairment: Epworth Sleepiness Scale (ESS), Global Impression of Clinical Change (GICC), sleep diary<br /><br>-Cognition: Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA)<br /><br>-Depression and Anxiety: Hamilton Depression Rating Scale (HADS)<br>
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