Parkinson's Disease
Conditions
Interventions
Intervention group:
Intervention will consist of blue light therapy being administered.
Participants will wear the Propeaq light therapy glasses for one hour twice
daily (total two hours each day).
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 - 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
Exclusion criteria
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 - Significant cognitive impairment as defined by the Mini-Mental State Examination (MMSE) score =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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study will be the change in Pittsburgh Sleep Quality Index score (PSQI). | — |
Secondary
| Measure | Time frame |
|---|---|
| The following parameter will serve as secondary outcome measures: a. Motor Symptoms measurements: - The MDS-Unified Parkinson*s Disease Rating scale (MDS-UPDRS) parts I-IV b. Non- motor symptoms measurements: - Sleep impairment: Epworth Sleepiness Scale (ESS), Global Impression of Clinical Change (GICC), sleep diary - Cognition: Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) - Depression and Anxiety: Hamilton Depression Rating Scale (HADS) | — |
Countries
Netherlands
Outcome results
None listed