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/NCT05972187</url>
    </required_header>
    <id_info>
      <org_study_id>NL81104.068.22</org_study_id>
      <nct_id>NCT05972187</nct_id>
    </id_info>
    <brief_title>The Effect of IEQ on Cognition and Health</brief_title>
    <acronym>IEQ-HUM</acronym>
    <official_title>The Effect of the Indoor Environmental Quality (IEQ) on Cognition and Health</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maastricht University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Maastricht University</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>
        The goal of this study is to learn about the effect of heat and humidity on cognition and&#xD;
        health. The main question[s] it aims to answer are:&#xD;
  &#xD;
        type of study: interventional participant population: 20-40years, both gender, healthy&#xD;
        Participants will be exposed for 4 different sessions of 8 hours at a time, to 32˚ C or 25˚ C&#xD;
        in combination with relative humidity of 30 %RH or 70 %RH.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Overall, the project aims to evaluate the effects of high vs. neutral temperature (32˚ C vs.&#xD;
        25˚ C) in combination with high vs. low humidity (30 %RH vs. 70 %RH) on cognition, for longer&#xD;
        exposure duration (8 hours). Deviations from the personal comfort zones are expected to&#xD;
        affect both subjective feelings and physiological parameters. Therefore, the following&#xD;
        parameters will be included: cognition, environmental perception, energy expenditure, body&#xD;
        temperatures.&#xD;
  &#xD;
        Main research question and primary objective:&#xD;
  &#xD;
        What is the impact of being exposed for 8 hours to a high humidity (RH 70%) versus low&#xD;
        humidity (RH 30%) on cognitive performance of individuals if the room temperature is 25ºC or&#xD;
        32ºC?&#xD;
  &#xD;
        This leads to the following hypotheses:&#xD;
  &#xD;
          -  Exposure to an indoor high relative humidity (RH 70%) at a warm temperature (32ºC) of a&#xD;
             long duration (8 hours) reduces the composite score, speed and accuracy of cognitive&#xD;
             performance compared to an exposure to a low RH (30%) at the same temperature (32ºC) due&#xD;
             to the humidity.&#xD;
  &#xD;
          -  An exposure to an indoor high relative humidity (RH 70%) at a neutral temperature (25ºC)&#xD;
             of a long duration (8 hours) would reduce the composite score, speed and accuracy of&#xD;
             cognitive performance compared to an exposure to a low RH (30%) at a neutral temperature&#xD;
             (25 ºC) due to previous literature for humidity influences at neutral temperatures.&#xD;
  &#xD;
        Secondary research question and secondary objective:&#xD;
  &#xD;
        What is the effect of high vs. neutral temperature (32˚ C vs. 25˚ C) in combination with high&#xD;
        vs. low humidity (30 %RH vs. 70 %RH) on physiological responses, environmental perception,&#xD;
        decision making, and bias behaviour?&#xD;
  &#xD;
        This leads to the following hypotheses:&#xD;
  &#xD;
          1. Does an 8 hour exposure to an elevated concentration of indoor humidity lead to an&#xD;
             increase in energy expenditure and/or a greater difference in proximal and distal blood&#xD;
             flow and skin temperature gradients compared to a lower indoor humidity for each of the&#xD;
             temperature settings?&#xD;
  &#xD;
          2. What are the effects of high humidity on substrate oxidation, blood pressure, heart rate&#xD;
             variability, proximal and distal skin temperature, risk behavior and decision-making&#xD;
             responses of individuals?&#xD;
  &#xD;
          3. What are the effects of higher humidity on environmental perception (thermal, air&#xD;
             quality, moisture/wetness) comfort, perception, and sensation?&#xD;
  &#xD;
               -  An exposure to an indoor high relative humidity (RH 70%) at a warm temperature&#xD;
                  (32ºC) of a long duration (8 hours) reduces the composite score, speed and accuracy&#xD;
                  of cognitive performance compared to an exposure to a high RH (70%) at a neutral&#xD;
                  temperature (25 ºC) due to the humidity and temperature.&#xD;
  &#xD;
               -  An exposure to an indoor low relative humidity (RH 30%) at a warm temperature&#xD;
                  (32ºC) of a long duration (8 hours) would reduce the composite score, speed and&#xD;
                  accuracy of cognitive performance compared to an exposure to the same low RH (30%)&#xD;
                  at a neutral temperature (25 ºC) due to the temperature.&#xD;
  &#xD;
        Exploratory research question and objective:&#xD;
  &#xD;
        What is the interaction effect of high vs. neutral temperature (32˚ C vs. 25˚ C) in&#xD;
        combination with high vs. low humidity (30 %RH vs. 70 %RH) on cognitive performance,&#xD;
        physiological responses, environmental perception, decision making, and bias behaviour?&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 18, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cognition</measure>
      <time_frame>1 month</time_frame>
      <description>Using a tablet based cognitive test battery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Heart Rate (bpm)</measure>
      <time_frame>1 month</time_frame>
      <description>Heart Rate measured using Polar heart rate belt in (bpm) with RR and ECG data extracted</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure (mmHg)</measure>
      <time_frame>1 month</time_frame>
      <description>Blood pressure - both systolic and diastolic pressures measured hourly using an automated blood pressure monitor and cuff</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Metabolic Rate (ml O2//min/kg)</measure>
      <time_frame>1 month</time_frame>
      <description>Metabolic rates measured through whole room calorimetry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin Temperature (C)</measure>
      <time_frame>1 month</time_frame>
      <description>Skin temperature measured using thermochron (ibuttons) at multiple sites</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body Core Temperature (C)</measure>
      <time_frame>1 month</time_frame>
      <description>Core Temperature measured via telemetric pill ingested in the morning</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Room Temperature (C)</measure>
      <time_frame>1 month</time_frame>
      <description>Environmental measures are measured continuously using temperature specific sensors in the room</description>
    </other_outcome>
    <other_outcome>
      <measure>Humidity (%)</measure>
      <time_frame>1 month</time_frame>
      <description>Environmental measures are measured continuously using humidity specific sensors in the room</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">26</enrollment>
    <condition>Environmental Exposure</condition>
    <condition>Temperature Change, Body</condition>
    <condition>Condition</condition>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Temperature and Humidity</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>32C or 25C and 30%RH or 70%RH</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Temperature and Humidity</intervention_name>
      <description>Temperature and Humidity of room changed</description>
      <arm_group_label>Temperature and Humidity</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  BMI between 18.5-26 kg/m2&#xD;
  &#xD;
            -  Age between 20-40 years&#xD;
  &#xD;
            -  Proficient with the English language in both verbal and written form&#xD;
  &#xD;
            -  Healthy; no illness or disease or prescribed medication within the last 3 months&#xD;
  &#xD;
            -  Steady dietary and sleeping habits&#xD;
  &#xD;
            -  Regularly physically active (i.e., regularly active but less than 3 times a week for&#xD;
               less than 2 hours per session at moderate intensity)&#xD;
  &#xD;
            -  Non-smoker or person who quit smoking more than five years ago&#xD;
  &#xD;
            -  Reside in the Netherlands (or surrounding countries) for at least 6 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects with cardiac problems and cardiovascular diseases, such as angina pectoris,&#xD;
               cardiac infarction, and arrhythmias&#xD;
  &#xD;
            -  Subjects with any medical condition requiring treatment and/or medication (except oral&#xD;
               contraceptives) that might interfere with the investigated parameters E.g., Extreme&#xD;
               chronotype, colour blindness, epilepsy&#xD;
  &#xD;
            -  Subjects with a disorder or disease (Parkinson, Attention Deficit Hyperactivity&#xD;
               Disorder (ADHD), Alzheimer, diabetes, cardiovascular disorder, respiratory impairments&#xD;
               (for example asthma), hypertension, obesity, or any other condition that can impair&#xD;
               the lung function), or Raynaud's phenomenon&#xD;
  &#xD;
            -  Subjects with abnormal diet and sleeping patters and/or abnormal body weight (weight&#xD;
               gain or loss &gt;3kg in the past month)&#xD;
  &#xD;
            -  Subjects who recently participated in other interventional biomedical study within 1&#xD;
               month prior to screening visit&#xD;
  &#xD;
            -  Subjects, who do not want to be informed about unexpected medical findings, or do not&#xD;
               wish that their treating physician will be informed, cannot participate in this study&#xD;
  &#xD;
            -  Subjects with previous covid infection in the past 3 months or any subject with&#xD;
               persistent long covid symptoms that may have caused ongoing loss of or altered sense&#xD;
               of smell&#xD;
  &#xD;
            -  Subjects who had severely altered sleep patterns in the past year&#xD;
  &#xD;
            -  Subjects employed with night shift work within the past year&#xD;
  &#xD;
            -  Subjects who consume more than two standard drinks of alcohol per day&#xD;
  &#xD;
            -  Subjects who consume more than two standard drinks of coffee per day&#xD;
  &#xD;
            -  Subjects who are pregnant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guy Plasqui, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Maastricht University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cynthia Ly, MSc</last_name>
      <phone>+31644602337</phone>
      <email>C.ly@maastrichtunicersity.nl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Maastricht University</name>
        <address>
          <city>Maastricht</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cynthia Ly</last_name>
        <phone>+31644602337</phone>
        <email>C.ly@maastrichtuniversity.no</email>
      </contact>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Temperature</keyword>
    <keyword>Humidity</keyword>
    <keyword>Thermoregulation</keyword>
    <keyword>Cognition</keyword>
    <keyword>Health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Body Temperature Changes</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>If requested raw data will be provided.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Ongoing, depends on the request.</ipd_time_frame>
      <ipd_access_criteria>Official request made stating the purpose of use for the data. Only individuals that consent to their data to be used in further analysis will be shared.</ipd_access_criteria>
    </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/NCT05972187
  org study id: NL81104.068.22
  nct id: NCT05972187
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to learn about the effect of heat and humidity on cognition and
        health. The main question[s] it aims to answer are:
  
        type of study: interventional participant population: 20-40years, both gender, healthy
        Participants will be exposed for 4 different sessions of 8 hours at a time, to 32˚ C or 25˚ C
        in combination with relative humidity of 30 %RH or 70 %RH.
  Overall, the project aims to evaluate the effects of high vs. neutral temperature (32˚ C vs.
        25˚ C) in combination with high vs. low humidity (30 %RH vs. 70 %RH) on cognition, for longer
        exposure duration (8 hours). Deviations from the personal comfort zones are expected to
        affect both subjective feelings and physiological parameters. Therefore, the following
        parameters will be included: cognition, environmental perception, energy expenditure, body
        temperatures.
  
        Main research question and primary objective:
  
        What is the impact of being exposed for 8 hours to a high humidity (RH 70%) versus low
        humidity (RH 30%) on cognitive performance of individuals if the room temperature is 25ºC or
        32ºC?
  
        This leads to the following hypotheses:
  
          -  Exposure to an indoor high relative humidity (RH 70%) at a warm temperature (32ºC) of a
             long duration (8 hours) reduces the composite score, speed and accuracy of cognitive
             performance compared to an exposure to a low RH (30%) at the same temperature (32ºC) due
             to the humidity.
  
          -  An exposure to an indoor high relative humidity (RH 70%) at a neutral temperature (25ºC)
             of a long duration (8 hours) would reduce the composite score, speed and accuracy of
             cognitive performance compared to an exposure to a low RH (30%) at a neutral temperature
             (25 ºC) due to previous literature for humidity influences at neutral temperatures.
  
        Secondary research question and secondary objective:
  
        What is the effect of high vs. neutral temperature (32˚ C vs. 25˚ C) in combination with high
        vs. low humidity (30 %RH vs. 70 %RH) on physiological responses, environmental perception,
        decision making, and bias behaviour?
  
        This leads to the following hypotheses:
  
          1. Does an 8 hour exposure to an elevated concentration of indoor humidity lead to an
             increase in energy expenditure and/or a greater difference in proximal and distal blood
             flow and skin temperature gradients compared to a lower indoor humidity for each of the
             temperature settings?
  
          2. What are the effects of high humidity on substrate oxidation, blood pressure, heart rate
             variability, proximal and distal skin temperature, risk behavior and decision-making
             responses of individuals?
  
          3. What are the effects of higher humidity on environmental perception (thermal, air
             quality, moisture/wetness) comfort, perception, and sensation?
  
               -  An exposure to an indoor high relative humidity (RH 70%) at a warm temperature
                  (32ºC) of a long duration (8 hours) reduces the composite score, speed and accuracy
                  of cognitive performance compared to an exposure to a high RH (70%) at a neutral
                  temperature (25 ºC) due to the humidity and temperature.
  
               -  An exposure to an indoor low relative humidity (RH 30%) at a warm temperature
                  (32ºC) of a long duration (8 hours) would reduce the composite score, speed and
                  accuracy of cognitive performance compared to an exposure to the same low RH (30%)
                  at a neutral temperature (25 ºC) due to the temperature.
  
        Exploratory research question and objective:
  
        What is the interaction effect of high vs. neutral temperature (32˚ C vs. 25˚ C) in
        combination with high vs. low humidity (30 %RH vs. 70 %RH) on cognitive performance,
        physiological responses, environmental perception, decision making, and bias behaviour?
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Cognition
  time frame: 1 month
  description: Using a tablet based cognitive test battery
  measure: Heart Rate (bpm)
  time frame: 1 month
  description: Heart Rate measured using Polar heart rate belt in (bpm) with RR and ECG data extracted
  measure: Blood pressure (mmHg)
  time frame: 1 month
  description: Blood pressure - both systolic and diastolic pressures measured hourly using an automated blood pressure monitor and cuff
  measure: Metabolic Rate (ml O2//min/kg)
  time frame: 1 month
  description: Metabolic rates measured through whole room calorimetry
  measure: Skin Temperature (C)
  time frame: 1 month
  description: Skin temperature measured using thermochron (ibuttons) at multiple sites
  measure: Body Core Temperature (C)
  time frame: 1 month
  description: Core Temperature measured via telemetric pill ingested in the morning
  measure: Room Temperature (C)
  time frame: 1 month
  description: Environmental measures are measured continuously using temperature specific sensors in the room
  measure: Humidity (%)
  time frame: 1 month
  description: Environmental measures are measured continuously using humidity specific sensors in the room
  arm group label: Temperature and Humidity
  arm group type: Experimental
  description: 32C or 25C and 30%RH or 70%RH
  intervention type: Other
  intervention name: Temperature and Humidity
  description: Temperature and Humidity of room changed
  arm group label: Temperature and Humidity
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Guy Plasqui, PHD
  role: Principal Investigator
  affiliation: Maastricht University
  last name: Cynthia Ly, MSc
  phone: +31644602337
  email: C.ly@maastrichtunicersity.nl
  facility: 
  status: Recruiting
  contact: 
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Body Temperature Changes
  sharing ipd: Yes
  ipd description: If requested raw data will be provided.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Analytic Code
  ipd time frame: Ongoing, depends on the request.
  ipd access criteria: Official request made stating the purpose of use for the data. Only individuals that consent to their data to be used in further analysis will be shared.