Status:
COMPLETED
Caffeine for Excessive Daytime Somnolence in Parkinson's Disease
Lead Sponsor:
Ron Postuma
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
University of Toronto
Conditions:
Parkinson's Disease
Excessive Daytime Somnolence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Many patients with Parkinson's disease (PD) have sleep problems, including excessive sleepiness during the day. This is probably due to degeneration of sleep-regulating areas in the brain. At present,...
Detailed Description
Parkinson's disease (PD) is a common neurodegenerative disorder characterized by motor disability and many disabling non-motor symptoms. Excessive daytime somnolence (EDS) is found in up to 50% of pat...
Eligibility Criteria
Inclusion
- A diagnosis of idiopathic PD
- Excessive daytime somnolence (defined as an Epworth sleepiness scale score of \>10).
Exclusion
- Estimated daily caffeine intake of more than 200 mg per day
- Active peptic ulcer disease
- Supraventricular cardiac arrhythmia (such as atrial fibrillation or atrial flutter)
- Uncontrolled hypertension - defined as systolic bp \>170 or diastolic bp \>110 on two consecutive readings
- EDS is caused by sleep apnea, restless legs syndrome, narcolepsy, shift work, or sleep promoting agents.
- Current use of prescribed alerting agents such as modafinil and methylphenidate
- Pre-menopausal women who are not using effective methods of birth control
- Dementia, defined as MMSE \<24/30 and ADL impairment secondary to cognitive loss, or inability to understand consent process
- Depression, as defined by a Beck Depression Inventory score of \>15.
- Changes to antiparkinsonian medication in the last 3 months, or changes to antiparkinsonian medication are anticipated during the study protocol.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00459420
Start Date
April 1 2007
End Date
July 1 2011
Last Update
April 16 2015
Active Locations (2)
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1
Toronto Western Hospital
Toronto, Ontario, Canada
2
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4