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

Parkinson's Disease research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria; 2. PD Hoehn and Yahr stage 2-4; 3. Pittsburgh Sleep Quality Index (PSQI) score >5 in group 1, and ≤5 in group 2; 4. 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: 1. Atypical or secondary forms of Parkinsonism; 2. Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26; 3. Presence of depression defined as the Beck Depression Inventory (BDI) score >14; 4. 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; 5. Use of SSRIs / SNRIs antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening; 6. Use of medications known to affect melatonin secretion; 7. Unstable/serious medical illness.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Parkinson's Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Light exposure

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Control

PD patients without sleep problems

PD patients with sleep problemslight exposure

PD patients with sleep problemlight exposure

Study Status

Recruiting

Start Date: June 2012

Completed Date: December 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: circadian rhythm of melatonin

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Aleksandar Videnovic, MD

Lead Sponsor: Massachusetts General Hospital

Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)

More information:https://clinicaltrials.gov/show/NCT01742182

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