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

Massachusetts General Hospital1 site in 1 country70 target enrollmentJune 2012

ConditionsParkinson's Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson's Disease
Sponsor: Massachusetts General Hospital
Enrollment: 70
Locations: 1
Primary Endpoint: Sleep Efficiency
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

June 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Aleksandar Videnovic, MD

Assistant Professor of Neurology

Massachusetts General Hospital

Eligibility Criteria

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.