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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2018-06-30

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.

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

PD patients without sleep problems

Group Type NO_INTERVENTION

No interventions assigned to this group

PD patients with sleep problems

light exposure

Group Type ACTIVE_COMPARATOR

Light exposure

Intervention Type OTHER

PD patients with sleep problem

light exposure

Group Type PLACEBO_COMPARATOR

Light exposure

Intervention Type OTHER

Interventions

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Light exposure

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes