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

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ClinicalTrials.gov Identifier: NCT04441697
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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. We 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
Parkinson Disease Diagnostic Test: Multiple sleep latency tests

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Study Type : Observational
Estimated 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 : June 1, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
continuous apomorphine delivery
apomorphine, subcutaneous administration, continuous delivery during 8 to 24 hours/day
Diagnostic Test: Multiple sleep latency tests
We measure the objective sleepiness by recording the electro-encephalogramm during four experimental diurnal naps. We also perform a nocturnal polysomnography prior to the tests for a better interpretation.
Other Name: Polysomnography

continous levodopa/carbidopa delivery
levodopa/carbidopa monohydrate, jejunal administration, continuous delivery during 8 to 24 hours/day
Diagnostic Test: Multiple sleep latency tests
We measure the objective sleepiness by recording the electro-encephalogramm during four experimental diurnal naps. We also perform a nocturnal polysomnography prior to the tests for a better interpretation.
Other Name: Polysomnography

deep brain stimulation
bilateral subthalamic electrical stimulation, intracranial neurosurgical electrodes, individual electrical parameters settings
Diagnostic Test: Multiple sleep latency tests
We measure the objective sleepiness by recording the electro-encephalogramm during four experimental diurnal naps. We also perform a nocturnal polysomnography prior to the tests for a better interpretation.
Other Name: Polysomnography




Primary Outcome Measures :
  1. Mean sleep latency [ Time Frame: before continuous antiparkinsonian treatment ]
    Algebric mean (in minutes) of the sleep latency for the four experimental naps

  2. Mean sleep latency [ Time Frame: 6 months after continuous antiparkinsonian treatment ]
    Algebric mean (in minutes) of the sleep latency for the four experimental naps

  3. Mean sleep latency [ Time Frame: 12 months after continous antiparkinsonian treatment ]
    Algebric mean (in minutes) of the sleep latency for the four experimental naps



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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-stimulating drugs intake
  • refusal to participate
  • legal protection
  • uncontrolled sleep apnea

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441697


Contacts
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Contact: Nicolas Carpentier 0033383858585 n.carpentier@chru-nancy.fr

Locations
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France
Nancy University Hospital Recruiting
Nancy, France, 54000
Contact: Nicolas Carpentier       n.carpentier@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Study Chair: El Mehdi Siaghy Research and Innovation Department
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04441697    
Other Study ID Numbers: 2020PI085
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Parkinson Disease
Sleepiness
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms