Monitoring of Sleepiness in Patients With Parkinson's Disease Before and During Treatment With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation
Sponsor study identifier
observational
30
1 country
1
Study Start
June 1, 2020
Actual (reported)Primary Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2020
Actual (reported)June 18, 2020
Actual (reported)June 22, 2020
Actual (reported)June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
apomorphine, subcutaneous administration, continuous delivery during 8 to 24 hours/day
levodopa/carbidopa monohydrate, jejunal administration, continuous delivery during 8 to 24 hours/day
bilateral subthalamic electrical stimulation, intracranial neurosurgical electrodes, individual electrical parameters settings
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.
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All the patients refered to the expert Parkinson Center of the Nancy University Hospital, with the diagnosis of Parkinson's disease at the stage of motor fluctuations, and indicated for a continuous dopaminergic delivery device or deep brain stimulation
Nancy University Hospital
Nancy, 54000, France
El Mehdi Siaghy
Research and Innovation Department
First Submitted
June 18, 2020
First Posted
June 22, 2020
Study Start
June 1, 2020
Actual (reported)Primary Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Evaluation of a Millimeter Wave Emission Bracelet for Improving Parkinson's Disease Symptoms
Contact the study team to confirm eligibility.
Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 6, 2021
Record last verified: 2021-07
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Source: ClinicalTrials.gov.
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