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/NCT06008184</url>
    </required_header>
    <id_info>
      <org_study_id>CER-VD : 2021-01674</org_study_id>
      <nct_id>NCT06008184</nct_id>
    </id_info>
    <brief_title>Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids</brief_title>
    <acronym>SensoCort</acronym>
    <official_title>Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire Vaudois</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire Vaudois</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>
        Cortisol is an essential for life hormone secreted in a pulsatile pattern on a diurnal&#xD;
        rhythm. Given the complexity of cortisol secretion on a circadian rhythm with pulsations,&#xD;
        current methods of cortisol measurement have limitations.&#xD;
  &#xD;
        Therefore, a non-invasive and ambulatory method would be useful to measure cortisol levels in&#xD;
        real-time.&#xD;
  &#xD;
        The main aim of the study is to compare cortisol levels across biological fluids (sweat,&#xD;
        saliva, interstitial fluid, and blood) in order to validate in the long term a continuous and&#xD;
        non-invasive cortisol measurement device (currently under development).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2021</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Cortisol levels in 4 biologicals fluids</measure>
      <time_frame>24 hours</time_frame>
      <description>Comparison of cortisol levels in these 4 biological fluids</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Aldosterone levels in 4 biological fluids</measure>
      <time_frame>24 hours</time_frame>
      <description>Comparison of aldosterone levels in these 4 biological fluids</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Glucocorticoid - comparison of repeated measures of glucocorticoid concentrations (cortisol, 18OHF, cortisone) profiles - over a period of 24 hours</measure>
      <time_frame>24 hours</time_frame>
      <description>Study of the diurnal rhythm and pulsatility in healthy participants (and later patients)&#xD;
  Diurnal rhythm: cosinor analysis. Comparison of nadir/acme of cortisol concentrations (and 18OHF, cortisone) among participants. Amplitude of the curve&#xD;
  Pulsatility analysis: frequency of the pulses and amplitude</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mineralocorticoid - comparison of repeated measures of aldosterone concentrations profiles - over a period of 24 hours</measure>
      <time_frame>24 hours</time_frame>
      <description>Study of the diurnal rhythm and pulsatility in healthy participants (and later patients)&#xD;
  Diurnal rhythm: cosinor analysis. Comparison of nadir/acme of aldosterone concentrations among participants. Amplitude of the curve&#xD;
  Pulsatility analysis: frequency of the pulses and amplitude</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Adrenal Insufficiency</condition>
    <condition>Cushing Syndrome</condition>
    <condition>Hyperaldosteronism</condition>
    <arm_group>
      <arm_group_label>Healthy controls</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>24 hours sampling of 4 biological fluids (blood, ISF, sweat and saliva)</intervention_name>
      <description>24 hours sampling of 4 biological fluids:&#xD;
  blood: sampling every 20 minutes (through a venous catheter)&#xD;
  ISF: automated sampling every 20 minutes (microdialysis technique connected to U-Rhythm device)&#xD;
  Sweat : collection of 1 to 3 samples at 4 differents timepoints&#xD;
  Saliva : sampling every hour (except during the night)</description>
      <arm_group_label>Healthy controls</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>24 hours sampling of ISF or sweat (after validating the correlation with blood)</intervention_name>
      <description>24 hours sampling in an ambulatory setting</description>
      <arm_group_label>Healthy controls</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy volunteers&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Healthy controls:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  age between 18 and 30 years old&#xD;
  &#xD;
            -  normal BMI 18 to 25 kg/m2&#xD;
  &#xD;
            -  weight stability&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnancy, breastfeeding, irregular menses&#xD;
  &#xD;
            -  any medical treatment&#xD;
  &#xD;
            -  any medical issues&#xD;
  &#xD;
            -  pilocarpine allergy, or latex allergy&#xD;
  &#xD;
            -  glaucoma or acute irritis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nelly Pitteloud, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre Hospitalier Universitaire Vaudois</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Adelina Ameti</last_name>
      <phone>0041795568630</phone>
      <email>adelina.ameti@chuv.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nathalie Vionnet, MD-PhD</last_name>
      <email>nathalie.vionnet@chuv.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Centre Hospitalier Universitaire Vaudois (CHUV)</name>
        <address>
          <city>Lausanne</city>
          <state>Vaud</state>
          <zip>1005</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Adelina Ameti</last_name>
        <phone>+41 79 556 68 30</phone>
        <email>adelina.ameti@chuv.ch</email>
      </contact>
      <contact_backup>
        <last_name>Emmanuelle Paccou</last_name>
        <phone>+41 79 556 60 13</phone>
        <email>emmanuelle.paccou@chuv.ch</email>
      </contact_backup>
      <investigator>
        <last_name>Nelly Pitteloud, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
      <investigator_full_name>Nelly Pitteloud</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adrenal Insufficiency</mesh_term>
      <mesh_term>Cushing Syndrome</mesh_term>
      <mesh_term>Hyperaldosteronism</mesh_term>
    </condition_browse>
    <!-- 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/NCT06008184
  org study id: CER-VD : 2021-01674
  nct id: NCT06008184
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cortisol is an essential for life hormone secreted in a pulsatile pattern on a diurnal
        rhythm. Given the complexity of cortisol secretion on a circadian rhythm with pulsations,
        current methods of cortisol measurement have limitations.
  
        Therefore, a non-invasive and ambulatory method would be useful to measure cortisol levels in
        real-time.
  
        The main aim of the study is to compare cortisol levels across biological fluids (sweat,
        saliva, interstitial fluid, and blood) in order to validate in the long term a continuous and
        non-invasive cortisol measurement device (currently under development).
  observational model: Other
  time perspective: Prospective
  measure: Cortisol levels in 4 biologicals fluids
  time frame: 24 hours
  description: Comparison of cortisol levels in these 4 biological fluids
  measure: Aldosterone levels in 4 biological fluids
  time frame: 24 hours
  description: Comparison of aldosterone levels in these 4 biological fluids
  measure: Glucocorticoid - comparison of repeated measures of glucocorticoid concentrations (cortisol, 18OHF, cortisone) profiles - over a period of 24 hours
  time frame: 24 hours
  description: Study of the diurnal rhythm and pulsatility in healthy participants (and later patients)
  Diurnal rhythm: cosinor analysis. Comparison of nadir/acme of cortisol concentrations (and 18OHF, cortisone) among participants. Amplitude of the curve
  Pulsatility analysis: frequency of the pulses and amplitude
  measure: Mineralocorticoid - comparison of repeated measures of aldosterone concentrations profiles - over a period of 24 hours
  time frame: 24 hours
  description: Study of the diurnal rhythm and pulsatility in healthy participants (and later patients)
  Diurnal rhythm: cosinor analysis. Comparison of nadir/acme of aldosterone concentrations among participants. Amplitude of the curve
  Pulsatility analysis: frequency of the pulses and amplitude
  arm group label: Healthy controls
  intervention type: Other
  intervention name: 24 hours sampling of 4 biological fluids (blood, ISF, sweat and saliva)
  description: 24 hours sampling of 4 biological fluids:
  blood: sampling every 20 minutes (through a venous catheter)
  ISF: automated sampling every 20 minutes (microdialysis technique connected to U-Rhythm device)
  Sweat : collection of 1 to 3 samples at 4 differents timepoints
  Saliva : sampling every hour (except during the night)
  arm group label: Healthy controls
  intervention type: Other
  intervention name: 24 hours sampling of ISF or sweat (after validating the correlation with blood)
  description: 24 hours sampling in an ambulatory setting
  arm group label: Healthy controls
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nelly Pitteloud, MD
  role: Principal Investigator
  affiliation: Centre Hospitalier Universitaire Vaudois
  last name: Adelina Ameti
  phone: 0041795568630
  email: adelina.ameti@chuv.ch
  last name: Nathalie Vionnet, MD-PhD
  email: nathalie.vionnet@chuv.ch
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Switzerland
  responsible party type: Principal Investigator
  investigator affiliation: Centre Hospitalier Universitaire Vaudois
  investigator full name: Nelly Pitteloud
  investigator title: Professor
  mesh term: Adrenal Insufficiency
  mesh term: Cushing Syndrome
  mesh term: Hyperaldosteronism