Parkinson Disease Clinical Trial
Official title:
Monitoring of Sleepiness in Patients With Parkinson's Disease Before and During Treatment With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation
NCT number | NCT04441697 |
Other study ID # | 2020PI085 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2020 |
Est. completion date | June 2023 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Nancy University Hospital | Nancy |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean sleep latency | Algebric mean (in minutes) of the sleep latency for the four experimental naps | before continuous antiparkinsonian treatment | |
Primary | Mean sleep latency | Algebric mean (in minutes) of the sleep latency for the four experimental naps | 6 months after continuous antiparkinsonian treatment | |
Primary | Mean sleep latency | Algebric mean (in minutes) of the sleep latency for the four experimental naps | 12 months after continous antiparkinsonian treatment |
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