Sleepiness in Parkinson's Patients With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation
- Conditions
- Parkinson Disease
- Interventions
- Diagnostic Test: Multiple sleep latency tests
- Registration Number
- NCT04441697
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
Sleepiness is frequent in parkinsonian patients, increasing with the duration of disease. By patients with motor fluctuations, continuous dopaminergic delivery devices or deep brain stimulation are justified to improve the motor prognosis. Antiparkinsonian treatments, especially dopaminergic agonists, may worsen the sleepiness and thus affect the quality of life. The investigators aimed to monitor sleepiness in parkinsonian patients before and during treatment with continous dopaminergic delivery device or deep brain stimulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- patient with Parkinson's disease and motor fluctuations
- and indicated for a continuous dopaminergic delivery device or deep brain stimulation
Exclusion Criteria
- age < 18 years
- refusal for the continuous dopaminergic delivery device or deep brain stimulation
- wake-promoting drugs intake
- refusal to participate
- legal protection
- uncontrolled sleep apnea
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description continous levodopa/carbidopa delivery Multiple sleep latency tests levodopa/carbidopa monohydrate, jejunal administration, continuous delivery during 8 to 24 hours/day deep brain stimulation Multiple sleep latency tests bilateral subthalamic electrical stimulation, intracranial neurosurgical electrodes, individual electrical parameters settings continuous apomorphine delivery Multiple sleep latency tests apomorphine, subcutaneous administration, continuous delivery during 8 to 24 hours/day
- Primary Outcome Measures
Name Time Method Mean sleep latency 12 months after continous antiparkinsonian treatment Algebric mean (in minutes) of the sleep latency for the four experimental naps
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nancy University Hospital
🇫🇷Nancy, France