Sleepiness in Parkinson's Patients With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation

Study Overview
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Brief Summary
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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.

Official Title
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Monitoring of Sleepiness in Patients With Parkinson's Disease Before and During Treatment With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation

Conditions
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Parkinson Disease

Intervention / Treatment
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* Diagnostic Test: Multiple sleep latency tests


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| continuous apomorphine delivery<br>apomorphine, subcutaneous administration, continuous delivery during 8 to 24 hours/day | Diagnostic Test: Multiple sleep latency tests<br>* The investigators measure the objective sleepiness by recording the electro-encephalogramm during four experimental diurnal naps. They also perform a nocturnal polysomnography prior to the tests for a better interpretation.<br>* Other names: Polysomnography;|
| continous levodopa/carbidopa delivery<br>levodopa/carbidopa monohydrate, jejunal administration, continuous delivery during 8 to 24 hours/day | Diagnostic Test: Multiple sleep latency tests<br>* The investigators measure the objective sleepiness by recording the electro-encephalogramm during four experimental diurnal naps. They also perform a nocturnal polysomnography prior to the tests for a better interpretation.<br>* Other names: Polysomnography;|
| deep brain stimulation<br>bilateral subthalamic electrical stimulation, intracranial neurosurgical electrodes, individual electrical parameters settings | Diagnostic Test: Multiple sleep latency tests<br>* The investigators measure the objective sleepiness by recording the electro-encephalogramm during four experimental diurnal naps. They also perform a nocturnal polysomnography prior to the tests for a better interpretation.<br>* Other names: Polysomnography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean sleep latency | Algebric mean (in minutes) of the sleep latency for the four experimental naps | before continuous antiparkinsonian treatment | 
| Mean sleep latency | Algebric mean (in minutes) of the sleep latency for the four experimental naps | 6 months after continuous antiparkinsonian treatment | 
| Mean sleep latency | Algebric mean (in minutes) of the sleep latency for the four experimental naps | 12 months after continous antiparkinsonian treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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continous dopaminergic delivery device, deep brain stimulation, sleepiness