BLUE LIGHT THERAPY FOR SLEEP IMPAIRMENT IN PARKINSON*S DISEASE - Pilot Study

Recruitment & Eligibility

Status: Completed

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
- 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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this study will be the change in Pittsburgh Sleep<br /><br>Quality Index score (PSQI). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>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<br /><br>Clinical Change (GICC), sleep diary<br /><br>- Cognition: Mini-Mental State Examination (MMSE), Montreal Cognitive<br /><br>Assessment (MoCA)<br /><br>- Depression and Anxiety: Hamilton Depression Rating Scale (HADS)</p><br>