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

Overview

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.

Full Title of Study: “Monitoring of Sleepiness in Patients With Parkinson’s Disease Before and During Treatment With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2023

Interventions

  • Diagnostic Test: 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.

Arms, Groups and Cohorts

  • continuous apomorphine delivery
    • apomorphine, subcutaneous administration, continuous delivery during 8 to 24 hours/day
  • continous levodopa/carbidopa delivery
    • levodopa/carbidopa monohydrate, jejunal administration, continuous delivery during 8 to 24 hours/day
  • deep brain stimulation
    • bilateral subthalamic electrical stimulation, intracranial neurosurgical electrodes, individual electrical parameters settings

Clinical Trial Outcome Measures

Primary Measures

  • Mean sleep latency
    • Time Frame: before continuous antiparkinsonian treatment
    • Algebric mean (in minutes) of the sleep latency for the four experimental naps
  • Mean sleep latency
    • Time Frame: 6 months after continuous antiparkinsonian treatment
    • Algebric mean (in minutes) of the sleep latency for the four experimental naps
  • Mean sleep latency
    • Time Frame: 12 months after continous antiparkinsonian treatment
    • Algebric mean (in minutes) of the sleep latency for the four experimental naps

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central Hospital, Nancy, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • El Mehdi Siaghy, Study Chair, Research and Innovation Department
  • Overall Contact(s)
    • Nicolas Carpentier, 0033383858585, n.carpentier@chru-nancy.fr

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