Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease

Study Overview
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Brief Summary
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Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain limited. The proposed research will examine markers of the circadian system, sleepiness and sleep quality in PD patients and healthy controls. Further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in PD.

Official Title
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Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: Light exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria; PD Hoehn and Yahr stage 2-4; Pittsburgh Sleep Quality Index (PSQI) score >5 in group 1, and ≤5 in group 2; Epworth Sleepiness Scale (ESS) score ≥10 in group 1, and <10 in group 2; Control participants will be matched for gender and age with PD participants. Exclusion Criteria: Atypical or secondary forms of Parkinsonism; Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26; Presence of depression defined as the Beck Depression Inventory (BDI) score >14; Use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible at least 4 weeks after the taper is completed; Use of SSRIs / SNRIs antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening; Use of medications known to affect melatonin secretion; Unstable/serious medical illness.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| No Intervention: PD patients without sleep problems<br> | |
| Active Comparator: PD patients with sleep problems<br>light exposure | Other: Light exposure<br> <br> |
| Placebo Comparator: PD patients with sleep problem<br>light exposure | Other: Light exposure<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| circadian rhythm of melatonin |  | June 2012- May 2017 | 
| Sleep Efficiency |  | June 2012- May 2017 | 
| Daytime Somnolence |  | June 2012- May 2017 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Excessive Daytime Sleepiness, Circadian Rhythms, Light Therapy