BLUE LIGHT THERAPY FOR SLEEP IMPAIRMENT IN PARKINSON*S DISEASE - Pilot Study - - Blue light in Parkinson disease

Radboud Universitair Medisch Centrum0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•- 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
•- Age of > 30 years (inclusively)
•- Score of 5 or more on the Pittsburgh Sleep Quality Index score (PSQI) or Excessive daytime sleepiness (EDS) defined by an Epworth Sleepiness Scale (ESS) score of 7 or more
•- Anti-PD treatment (such as levodopa formulations, dopamine agonists, selective MAO-B inhibitors, anticholinergic agents or amantadine) at a stable dose in the last 30 days prior to the initial screening assessment

•- 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
•- Significant cognitive impairment as defined by the Mini-Mental State Examination (MMSE) score <24
•- Clinically significant psychiatric illness, including psychotic attacks, major depressive disorder (HAM-D = Hamilton Depression Rating Scale >=14). Subjects with a lifetime history of suicidal attempt (including an active attempt, interrupted attempt or aborted attempt)
•- Antidepressant treatment for less than 3 months prior to screening
•- Participation in other, interventional, research studies
•- Known conditions associated with sleep disorders other than PD or conditions inferring with the delivery of the blue light treatment:
•Obstructive sleep apnoea syndrome
•Eye-related diseases (e.g. cataract, glaucoma, blindness)
•Any other condition that in the opinion of the investigator may interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part in the study
•Current or history of malignancy or migraine within 5 years before screening
•Current use or use within three months prior the initial screening of hypnosedative or stimulant drugs such as benzodiazepines or melatonin

发起方