<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04441697</url>
  </required_header>
  <id_info>
    <org_study_id>2020PI085</org_study_id>
    <nct_id>NCT04441697</nct_id>
  </id_info>
  <brief_title>Sleepiness in Parkinson's Patients With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation</brief_title>
  <official_title>Monitoring of Sleepiness in Patients With Parkinson's Disease Before and During Treatment With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleepiness is frequent in parkinsonian patients, increasing with the duration of disease. By&#xD;
      patients with motor fluctuations, continuous dopaminergic delivery devices or deep brain&#xD;
      stimulation are justified to improve the motor prognosis. Antiparkinsonian treatments,&#xD;
      especially dopaminergic agonists, may worsen the sleepiness and thus affect the quality of&#xD;
      life. The investigators aimed to monitor sleepiness in parkinsonian patients before and&#xD;
      during treatment with continous dopaminergic delivery device or deep brain stimulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean sleep latency</measure>
    <time_frame>before continuous antiparkinsonian treatment</time_frame>
    <description>Algebric mean (in minutes) of the sleep latency for the four experimental naps</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean sleep latency</measure>
    <time_frame>6 months after continuous antiparkinsonian treatment</time_frame>
    <description>Algebric mean (in minutes) of the sleep latency for the four experimental naps</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean sleep latency</measure>
    <time_frame>12 months after continous antiparkinsonian treatment</time_frame>
    <description>Algebric mean (in minutes) of the sleep latency for the four experimental naps</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>continuous apomorphine delivery</arm_group_label>
    <description>apomorphine, subcutaneous administration, continuous delivery during 8 to 24 hours/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>continous levodopa/carbidopa delivery</arm_group_label>
    <description>levodopa/carbidopa monohydrate, jejunal administration, continuous delivery during 8 to 24 hours/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>deep brain stimulation</arm_group_label>
    <description>bilateral subthalamic electrical stimulation, intracranial neurosurgical electrodes, individual electrical parameters settings</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Multiple sleep latency tests</intervention_name>
    <description>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.</description>
    <arm_group_label>continous levodopa/carbidopa delivery</arm_group_label>
    <arm_group_label>continuous apomorphine delivery</arm_group_label>
    <arm_group_label>deep brain stimulation</arm_group_label>
    <other_name>Polysomnography</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All the patients refered to the expert Parkinson Center of the Nancy University Hospital,&#xD;
        with the diagnosis of Parkinson's disease at the stage of motor fluctuations, and indicated&#xD;
        for a continuous dopaminergic delivery device or deep brain stimulation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with Parkinson's disease and motor fluctuations&#xD;
&#xD;
          -  and indicated for a continuous dopaminergic delivery device or deep brain stimulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  refusal for the continuous dopaminergic delivery device or deep brain stimulation&#xD;
&#xD;
          -  wake-promoting drugs intake&#xD;
&#xD;
          -  refusal to participate&#xD;
&#xD;
          -  legal protection&#xD;
&#xD;
          -  uncontrolled sleep apnea&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>El Mehdi Siaghy</last_name>
    <role>Study Chair</role>
    <affiliation>Research and Innovation Department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicolas Carpentier</last_name>
    <phone>0033383858585</phone>
    <email>n.carpentier@chru-nancy.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nancy University Hospital</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas Carpentier</last_name>
      <email>n.carpentier@chru-nancy.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>July 30, 2021</last_update_submitted>
  <last_update_submitted_qc>July 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>continous dopaminergic delivery device</keyword>
  <keyword>deep brain stimulation</keyword>
  <keyword>sleepiness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Sleepiness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04441697
org study id: 2020PI085
nct id: NCT04441697
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Mean sleep latency
time frame: before continuous antiparkinsonian treatment
description: Algebric mean (in minutes) of the sleep latency for the four experimental naps
measure: Mean sleep latency
time frame: 6 months after continuous antiparkinsonian treatment
description: Algebric mean (in minutes) of the sleep latency for the four experimental naps
measure: Mean sleep latency
time frame: 12 months after continous antiparkinsonian treatment
description: Algebric mean (in minutes) of the sleep latency for the four experimental naps
arm group label: continuous apomorphine delivery
description: apomorphine, subcutaneous administration, continuous delivery during 8 to 24 hours/day
arm group label: continous levodopa/carbidopa delivery
description: levodopa/carbidopa monohydrate, jejunal administration, continuous delivery during 8 to 24 hours/day
arm group label: deep brain stimulation
description: bilateral subthalamic electrical stimulation, intracranial neurosurgical electrodes, individual electrical parameters settings
intervention type: Diagnostic Test
intervention name: Multiple sleep latency tests
description: 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.
arm group label: continous levodopa/carbidopa delivery
arm group label: continuous apomorphine delivery
arm group label: deep brain stimulation
other name: Polysomnography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: El Mehdi Siaghy
role: Study Chair
affiliation: Research and Innovation Department
last name: Nicolas Carpentier
phone: 0033383858585
email: n.carpentier@chru-nancy.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Sleepiness
sharing ipd: No