xml: <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/NCT06017882</url>
    </required_header>
    <id_info>
      <org_study_id>2023PBMD06</org_study_id>
      <secondary_id>2023-A01101-44</secondary_id>
      <nct_id>NCT06017882</nct_id>
    </id_info>
    <brief_title>Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload</brief_title>
    <acronym>CogPhyAero</acronym>
    <official_title>Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Direction Centrale du Service de Santé des Armées</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Direction Centrale du Service de Santé des Armées</source>
    <oversight_info>
      <has_dmc>No</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>
        Fighter pilots have to perform tasks requiring high mental workload during moderate-intensity&#xD;
        acceleration phases (2 to 3G) that can last several minutes. When these accelerations are&#xD;
        performed in the body axis (+Gz), they induce a redistribution of blood flow in the lower&#xD;
        limbs associated with a decrease in cerebral blood flow, partially compensated by activation&#xD;
        of the sympathetic nervous system (baroreflex).&#xD;
  &#xD;
        The main hypothesis is that the effects of these prolonged accelerations, even of moderate&#xD;
        intensity (&lt;+4Gz), could impair pilots' ability to perform complex cognitive tasks, with&#xD;
        potential consequences for flight safety and mission conduct.&#xD;
  &#xD;
        Moreover, flight missions are often performed after sleep debt, which is known to induce&#xD;
        cardiovascular responses, sympathetic nervous system activation and impaired mental&#xD;
        performance.&#xD;
  &#xD;
        The secondary hypothesis is that sleep debt (3h of time spent in bed) may increase the&#xD;
        impairment of cognitive performance during prolonged acceleration.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Difference in average tracking accuracy on the simulator MATB-II depending on centrifuge acceleration (quantitative measurement)</measure>
      <time_frame>Through study completion (26 months)</time_frame>
      <description>MATB-II (Multi Attribute Task Battery) is a complex task simulator that mimics realistic tasks commonly performed by aircraft pilots during flight. Among these tasks, target tracking involves positioning a reticle at the center of the simulator's artificial horizon. The variance of the reticle's position as a function of the acceleration received in the centrifuge will be the primary outcome mesure in this study. This is a quantitative measure provided by the simulator.</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Sleep Deprivation</condition>
    <arm_group>
      <arm_group_label>Group A : Usual sleep *2 ; Deprivation *2</arm_group_label>
      <description>V1-&gt;V3 id. V4 : Usual sleep and test series (easy; difficult; difficult) V5 : Usual sleep and test series (difficult; easy; easy) V6 : Sleep deprivation and test series (easy; easy; difficult) V7 : Sleep deprivation and test series (difficult; difficult; easy)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B : Usual sleep ; Deprivation; Deprivation ; Usual sleep</arm_group_label>
      <description>V1-&gt;V3 id. V4 : Usual sleep and test series ( difficult; difficult ; easy) V5 : Sleep deprivation and test series (easy; difficult; difficult) V6 : Sleep deprivation and test series (difficult; easy; easy) V7 : Usual sleep and test series (easy ; easy ; difficult)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group C : Deprivation; Usual sleep ; Deprivation ; Usual sleep</arm_group_label>
      <description>V1-&gt;V3 id. V4 : Sleep deprivation and test series (easy; easy; difficult) V5 : Usual sleep and test series (difficult; difficult; easy) V6 : Sleep deprivation and test series (easy; difficult; difficult) V7 : Usual and test series (difficult; easy; easy)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group D : Deprivation ; Deprivation ; Usual sleep ; Usual sleep</arm_group_label>
      <description>V1-&gt;V3 id. V4 : Sleep deprivation and test series (difficult; easy; easy) V5 : Sleep deprivation and test series (easy; difficult; easy) V6 : Usual sleep and test series ( difficult; easy ; easy) V7 : Usual sleep and test series (easy ; difficult; difficult)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Partial sleep deprivation</intervention_name>
      <arm_group_label>Group A : Usual sleep *2 ; Deprivation *2</arm_group_label>
      <arm_group_label>Group B : Usual sleep ; Deprivation; Deprivation ; Usual sleep</arm_group_label>
      <arm_group_label>Group C : Deprivation; Usual sleep ; Deprivation ; Usual sleep</arm_group_label>
      <arm_group_label>Group D : Deprivation ; Deprivation ; Usual sleep ; Usual sleep</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population is composed of healthy subjects .&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy subject (male or female);&#xD;
  &#xD;
            -  Tobacco consumption &lt; 5 cigarettes per day or nicotine-free vapour;&#xD;
  &#xD;
            -  Regular physical activity (between 1 and 8 hours per week);&#xD;
  &#xD;
            -  Affiliated or entitled to a social security scheme;&#xD;
  &#xD;
            -  Having given their consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presenting an active medical pathology or a history &lt;6 months (cardiological, renal,&#xD;
               hepatic, cutaneous, neurological, psychiatric...), or a significant deviation from&#xD;
               normal values observed during questioning, clinical examination or electrocardiogram&#xD;
               (ECG);&#xD;
  &#xD;
            -  BMI &gt; 30 (cardiovascular risk factor);&#xD;
  &#xD;
            -  Have a medical contraindication to sporting activities;&#xD;
  &#xD;
            -  Taking a medical treatment;&#xD;
  &#xD;
            -  Habitual sleep duration &lt; 6 hours;&#xD;
  &#xD;
            -  Presenting a sleep disorder confirmed by questionnaire (Pittsburgh Sleep Quality Index&#xD;
               Questionnaire &gt; 5);&#xD;
  &#xD;
            -  Pregnant or breastfeeding&#xD;
  &#xD;
            -  Not covered by a health insurance plan;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sauvet</last_name>
      <phone>178651275</phone>
      <phone_ext>+33</phone_ext>
      <email>fabien.sauvet@intradef.gouv.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Institut de Recherche Biomédicale des Armées</name>
        <address>
          <city>Brétigny-sur-Orge</city>
          <zip>91223</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Fabien SAUVET, MD, PhD</last_name>
        <phone>178651275</phone>
        <phone_ext>+33</phone_ext>
        <email>fabien.sauvet@intradef.gouv.fr</email>
      </contact>
      <contact_backup>
        <last_name>Anaïs PONTIGGIA</last_name>
        <email>anais.pontiggia@intradef.gouv.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>acceleration</keyword>
    <keyword>mental workload</keyword>
    <keyword>aerospace medicine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Deprivation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017882
  org study id: 2023PBMD06
  secondary id: 2023-A01101-44
  nct id: NCT06017882
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Fighter pilots have to perform tasks requiring high mental workload during moderate-intensity
        acceleration phases (2 to 3G) that can last several minutes. When these accelerations are
        performed in the body axis (+Gz), they induce a redistribution of blood flow in the lower
        limbs associated with a decrease in cerebral blood flow, partially compensated by activation
        of the sympathetic nervous system (baroreflex).
  
        The main hypothesis is that the effects of these prolonged accelerations, even of moderate
        intensity (<+4Gz), could impair pilots' ability to perform complex cognitive tasks, with
        potential consequences for flight safety and mission conduct.
  
        Moreover, flight missions are often performed after sleep debt, which is known to induce
        cardiovascular responses, sympathetic nervous system activation and impaired mental
        performance.
  
        The secondary hypothesis is that sleep debt (3h of time spent in bed) may increase the
        impairment of cognitive performance during prolonged acceleration.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Difference in average tracking accuracy on the simulator MATB-II depending on centrifuge acceleration (quantitative measurement)
  time frame: Through study completion (26 months)
  description: MATB-II (Multi Attribute Task Battery) is a complex task simulator that mimics realistic tasks commonly performed by aircraft pilots during flight. Among these tasks, target tracking involves positioning a reticle at the center of the simulator's artificial horizon. The variance of the reticle's position as a function of the acceleration received in the centrifuge will be the primary outcome mesure in this study. This is a quantitative measure provided by the simulator.
  arm group label: Group A : Usual sleep *2 ; Deprivation *2
  description: V1->V3 id. V4 : Usual sleep and test series (easy; difficult; difficult) V5 : Usual sleep and test series (difficult; easy; easy) V6 : Sleep deprivation and test series (easy; easy; difficult) V7 : Sleep deprivation and test series (difficult; difficult; easy)
  arm group label: Group B : Usual sleep ; Deprivation; Deprivation ; Usual sleep
  description: V1->V3 id. V4 : Usual sleep and test series ( difficult; difficult ; easy) V5 : Sleep deprivation and test series (easy; difficult; difficult) V6 : Sleep deprivation and test series (difficult; easy; easy) V7 : Usual sleep and test series (easy ; easy ; difficult)
  arm group label: Group C : Deprivation; Usual sleep ; Deprivation ; Usual sleep
  description: V1->V3 id. V4 : Sleep deprivation and test series (easy; easy; difficult) V5 : Usual sleep and test series (difficult; difficult; easy) V6 : Sleep deprivation and test series (easy; difficult; difficult) V7 : Usual and test series (difficult; easy; easy)
  arm group label: Group D : Deprivation ; Deprivation ; Usual sleep ; Usual sleep
  description: V1->V3 id. V4 : Sleep deprivation and test series (difficult; easy; easy) V5 : Sleep deprivation and test series (easy; difficult; easy) V6 : Usual sleep and test series ( difficult; easy ; easy) V7 : Usual sleep and test series (easy ; difficult; difficult)
  intervention type: Other
  intervention name: Partial sleep deprivation
  arm group label: Group A : Usual sleep *2 ; Deprivation *2
  arm group label: Group B : Usual sleep ; Deprivation; Deprivation ; Usual sleep
  arm group label: Group C : Deprivation; Usual sleep ; Deprivation ; Usual sleep
  arm group label: Group D : Deprivation ; Deprivation ; Usual sleep ; Usual sleep
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sauvet
  phone: 178651275
  phone ext: +33
  email: fabien.sauvet@intradef.gouv.fr
  facility: 
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor
  mesh term: Sleep Deprivation
  sharing ipd: Undecided