Sleepiness in Parkinson's Patients With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation
NCT ID: NCT04441697
Last Updated: 2021-08-06
Study Results
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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UNKNOWN
30 participants
OBSERVATIONAL
2020-06-01
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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continuous apomorphine delivery
apomorphine, subcutaneous administration, continuous delivery during 8 to 24 hours/day
Multiple sleep latency tests
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.
continous levodopa/carbidopa delivery
levodopa/carbidopa monohydrate, jejunal administration, continuous delivery during 8 to 24 hours/day
Multiple sleep latency tests
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.
deep brain stimulation
bilateral subthalamic electrical stimulation, intracranial neurosurgical electrodes, individual electrical parameters settings
Multiple sleep latency tests
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.
Interventions
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Multiple sleep latency tests
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* and indicated for a continuous dopaminergic delivery device or deep brain stimulation
Exclusion Criteria
* refusal for the continuous dopaminergic delivery device or deep brain stimulation
* wake-promoting drugs intake
* refusal to participate
* legal protection
* uncontrolled sleep apnea
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Principal Investigators
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El Mehdi Siaghy
Role: STUDY_CHAIR
Research and Innovation Department
Locations
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Nancy University Hospital
Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020PI085
Identifier Type: -
Identifier Source: org_study_id
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