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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT04441697
Collaborator
(none)
30
Enrollment
1
Location
36
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Multiple sleep latency tests

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Monitoring of Sleepiness in Patients With Parkinson's Disease Before and During Treatment With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
continuous apomorphine delivery

apomorphine, subcutaneous administration, continuous delivery during 8 to 24 hours/day

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.
Other Names:
  • Polysomnography

    		•
    continous levodopa/carbidopa delivery

    levodopa/carbidopa monohydrate, jejunal administration, continuous delivery during 8 to 24 hours/day

    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.
    Other Names:
  • Polysomnography

    		•
    deep brain stimulation

    bilateral subthalamic electrical stimulation, intracranial neurosurgical electrodes, individual electrical parameters settings

    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.
    Other Names:
  • Polysomnography

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean sleep latency [before continuous antiparkinsonian treatment]

      Algebric mean (in minutes) of the sleep latency for the four experimental naps

    2. Mean sleep latency [6 months after continuous antiparkinsonian treatment]

      Algebric mean (in minutes) of the sleep latency for the four experimental naps

    3. Mean sleep latency [12 months after continous antiparkinsonian treatment]

      Algebric mean (in minutes) of the sleep latency for the four experimental naps

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nancy University Hospital Nancy France 54000

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    • Study Chair: El Mehdi Siaghy, Research and Innovation Department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT04441697
    Other Study ID Numbers:
    • 2020PI085
    First Posted:
    Jun 22, 2020
    Last Update Posted:
    Aug 6, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Central Hospital, Nancy, France
    continous dopaminergic delivery device
    deep brain stimulation
    sleepiness
    Additional relevant MeSH terms:
    Parkinson Disease
    Sleepiness

    Study Results

    No Results Posted as of Aug 6, 2021