<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/NCT04431596</url>
  </required_header>
  <id_info>
    <org_study_id>H20-0010</org_study_id>
    <nct_id>NCT04431596</nct_id>
  </id_info>
  <brief_title>Military Alerting System for Monitoring Body Temperature During Active Cooling</brief_title>
  <acronym>MAMBA</acronym>
  <official_title>Computational Initiative for Performance Monitoring: Military Alerting System for Monitoring Body Temperature During Active Cooling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Connecticut</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biotechnology High Performance Computing Software Applications Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Connecticut</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>
      BHSAI is developing a computational system that provides early alerts of a rise in core body&#xD;
      temperature to help reduce the risk of heat injury in the field and during training. The goal&#xD;
      of the body temperature alerting system is to use it during rest, exercise in the heat and&#xD;
      during body cooling. Using this system during cooling will allow healthcare professionals and&#xD;
      military personnel monitor core temperature to ensure cooling is effective (and prevent&#xD;
      hypothermia). Therefore, the primary purpose of this investigation is to validate a body&#xD;
      temperature alerting system using physiological responses that occur during rest, exercise in&#xD;
      the heat and during body cooling. Multiple cooling modalities will be validated. The&#xD;
      effectiveness of each cooling modality (passive cooling, mist-fan cooling, hand/forearm&#xD;
      immersion) on physiological variables after exercise in the heat will be assessed. Lastly,&#xD;
      subject characteristics (demographic and anthropometric characteristics) will be examined to&#xD;
      examine their effect on physiological variables during exercise in the heat and during body&#xD;
      cooling with each cooling modality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be completed in the following timeline:&#xD;
&#xD;
      Visit 1: Baseline and VO2max Testing Visit 2-4: Trial 1, 2 and 3&#xD;
&#xD;
      Visit specific information is described below, however, specific data collection protocols&#xD;
      for dependent variables and procedures are included below the description of the study&#xD;
      design.&#xD;
&#xD;
      Visit 1: Baseline and VO2max Testing&#xD;
&#xD;
      Participants who are approved to participate will be scheduled for a baseline and VO2max&#xD;
      testing day. Upon arrival to the lab, subjects will provide a urine sample in a clean urine&#xD;
      cup. Urine specific gravity and urine color will be assessed. Nude body mass will be also be&#xD;
      recorded. Privacy will be afforded for each participant while obtaining body mass measures by&#xD;
      taking measurements with the participant alone in a private room behind a solid, closed door,&#xD;
      and the research reading the scale outside of the room. Participants will only be permitted&#xD;
      to continue to the VO2max test if the euhydrated criteria of a urine specific gravity (USG)&#xD;
      &lt;1.025 is met. If the participant arrives with a USG between 1.020 and 1.025, the subject&#xD;
      will be asked to drink 500 mL of water to ensure proper hydration status. Height will be&#xD;
      measured with a tape measure on Visit 1. Percent body fat will be calculated using a 7-site&#xD;
      evaluation of skin fold thickness using skin fold calipers. A researcher will use appropriate&#xD;
      grasping technique to measure skin fold thickness on the chest, iliac, tricep, calf,&#xD;
      shoulder, abdomen, and thigh. This will take less than 5 minutes to complete. This&#xD;
      information will be used to describe the subject demographics. Participants will also be&#xD;
      asked to complete a maximal oxygen uptake (VO2max) test on a treadmill in a thermoneutral&#xD;
      environment. This test will provide aerobic fitness levels of the participants. This visit&#xD;
      will take approximately 1-2 hours.&#xD;
&#xD;
      Visit 2-3: Trials 1, 2, 3&#xD;
&#xD;
      Participant numbers will be randomly assigned, and trials will be ordered with a random&#xD;
      number generator and assigned to a participant number. These orders will be counterbalanced&#xD;
      between participants to ensure that there is not an order effect, and each participant will&#xD;
      complete three trials as part of the study. Participants will be allowed to make-up trial&#xD;
      visits if they are sick, suffer an injury or do not meet hydration requirements. Participants&#xD;
      will be asked if they have a current illness or taking medications to determine whether they&#xD;
      can complete the exercise trial. The participant's visit will be rescheduled if they have a&#xD;
      fever, current illness or taking medications that influence body temperature.&#xD;
&#xD;
      Participants will complete three trials on three separate days in a randomized counter&#xD;
      balanced order:&#xD;
&#xD;
      Trial Cooling Intervention&#xD;
&#xD;
        1. Passive Cooling&#xD;
&#xD;
        2. Mist-fan Cooling&#xD;
&#xD;
        3. Forearm Immersion&#xD;
&#xD;
      The exercise protocol and recovery portions of this study will be conducted in a climatic&#xD;
      chamber with ambient temperature approximately 30-40C and relative humidity at approximately&#xD;
      30-70%. Participants will drink ad libitum throughout the exercise trial.&#xD;
&#xD;
      Upon arrival to the lab, participants will be asked to indicate if they have consumed alcohol&#xD;
      or caffeine in the last 24 hours and 12 hours, respectively. They will not be asked to&#xD;
      specify exactly what they have consumed, but if they provide a positive indication, their&#xD;
      trial will be rescheduled for another day. Participants will provide a small urine sample in&#xD;
      a clean urine cup, and a nude body mass will be measured. Upon arrival to the lab, hydration&#xD;
      status will be assessed by urine specific gravity, nude body mass and urine color.&#xD;
      Participants will only be permitted to continue to the exercise trial if the euhydrated&#xD;
      criteria of a urine specific gravity (USG) &lt;1.025 is met. If the participant arrives with a&#xD;
      USG between 1.020 and 1.025, the subject will be asked to drink 500 mL of water to ensure&#xD;
      proper hydration status. Participants will be given instructions at the prior visit about how&#xD;
      to obtain desired hydration status for the upcoming trial. Participants will insert a rectal&#xD;
      probe and wear a heart rate monitor strap. Additionally, participants will wear 7-site skin&#xD;
      temperature sensors. Researchers will apply the skin temperature sensors with medical tape to&#xD;
      the participants' chest, upper arm, thigh, neck, abdomen, thigh, back, and calf. The&#xD;
      participants will also be asked to complete a subjective sleep questionnaire upon arriving to&#xD;
      the lab. Participants will wear a battle dress uniform (BDU) during all exercise and rest&#xD;
      blocks. Three BDU sizes for the blouse and pants (small, medium, large) will be available for&#xD;
      the participants. A belt will be used to ensure the BDU fits appropriately. Participants will&#xD;
      not be able to keep the BDU- BDUs will be washed (according to manufacturer's instructions)&#xD;
      and re-used for participants. BDU manufacturer's instructions is identical to standard&#xD;
      washing cycle (detergent and washing machine dry). Participants will wear the wrist-based&#xD;
      devices (provided by BHSAI) on their non-dominant arm throughout the testing. The wrist&#xD;
      device must be placed approximately 1-inch proximal to the wrist and be fitted snuggly for&#xD;
      accurate heart-rate measurements. The wrist device is used to estimate heart rate using&#xD;
      infrared technology. The wrist device estimates of heart rate will be compared to the polar&#xD;
      heart rate monitor (gold standard). The body alerting system uses heart rate from the wrist&#xD;
      device and the environmental conditions to estimate body temperature. The sponsor of the&#xD;
      study will use rectal temperature and the 7-site skin temperature sensors to alter the&#xD;
      algorithm (not in real time- from the collected data) to better estimate body temperature.&#xD;
      The future goal is to have the body alerting system imbedded in the watch.&#xD;
&#xD;
      Participants will enter the environmental chamber and sit for 30 minutes to become&#xD;
      equilibrated. The environmental chamber will be set to 36C ambient temperature, 30% relative&#xD;
      humidity After baseline measures of heart rate, rectal temperature, participants will&#xD;
      complete the perceptual indices. Participants will also complete an environmental symptoms&#xD;
      questionnaire (ESQ).&#xD;
&#xD;
      The trial will consist of three, 50-minute intervals of walking and running at approximately&#xD;
      30-50% of VO2max and 60-80% of VO2max, respectively. Each 50-minute exercise block with be&#xD;
      followed by a 30-minute break where cooling will occur. Participants will be allowed to drink&#xD;
      ad libitum throughout the exercise trial. The participant will be cooled for approximately 30&#xD;
      minutes with their assigned cooling modality. Rectal temperature, skin temperature, heart&#xD;
      rate, perceptual measures, and mood will be collected at various time points before, during,&#xD;
      and after exercise and cooling.&#xD;
&#xD;
      Passive Cooling: Participants will be asked to sit in a chair in the climate chamber for&#xD;
      passive cooling.&#xD;
&#xD;
      Mist-fan cooling: A mist-fan will be placed in front of the participant during mist-fan&#xD;
      cooling. Participants will be asked to roll up their BDU sleeves to increase skin surface&#xD;
      area. The temperature of the mist and wind speed of the fan will be recorded.&#xD;
&#xD;
      Forearm immersion: The participant will place their forearm in approximately 20C water during&#xD;
      forearm immersion.&#xD;
&#xD;
      Data collection will be divided into two separate phases. A pilot study will be first&#xD;
      conducted in which the first two participants will complete all study laboratory visits. Data&#xD;
      from those trials will be shared with the sponsor for review before continuation of data&#xD;
      collection.&#xD;
&#xD;
      Participants will undergo the same procedures for the pilot testing as regular testing. Pilot&#xD;
      testing data will be included in the dataset. Following approval from the sponsor, data&#xD;
      collection will resume. Each trial will be approximately 4-5 hours.&#xD;
&#xD;
      All devices will be properly cleaned according to manufacturer's instruction prior to use by&#xD;
      other participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2020</start_date>
  <completion_date type="Actual">December 9, 2020</completion_date>
  <primary_completion_date type="Actual">December 9, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Participants receive three cooling treatments on separate study visits: 1) passive cooling 2) mist-fan cooling and 3) forearm immersion cooling</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Rectal Temperature</measure>
    <time_frame>Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)</time_frame>
    <description>Rectal thermometer will be self-inserted by participant to assess core temperature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Mean Skin Temperature</measure>
    <time_frame>Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)</time_frame>
    <description>7 skin temperature sensors will be placed on the subject (neck, chest, shoulder,back, abdomen, thigh, calf)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Heart Rate</measure>
    <time_frame>Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)</time_frame>
    <description>A heart rate monitor will be worn by participant throughout exercise/cooling protocol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Rating of Perceived Exertion (RPE)</measure>
    <time_frame>Measured every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)</time_frame>
    <description>6-20 scale that indicates how hard the participant feels they are working. 6 represents rest and 20 represents maximal exertion. A high score indicates more perceived exertion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Thermal Sensation (TS)</measure>
    <time_frame>Measured every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)</time_frame>
    <description>0-8 Scale (cold to hot) that indicated how cold or hot the participate feels. 0 = extremely cold, 8 = extremely hot.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Perception of Fatigue</measure>
    <time_frame>Measured every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)</time_frame>
    <description>0-10 (no fatigue to extreme fatigue) Scale that indicates how fatigued the participate feels. High score indicates more fatigue (negative outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Perception of Thirst</measure>
    <time_frame>Measured every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)</time_frame>
    <description>0-9 (no thirst to extreme thirst) Scale that indicates how thirsty the subject feels. A higher score is considered a negative outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Environmental Symptoms</measure>
    <time_frame>Before the start of exercise block 1</time_frame>
    <description>An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Environmental Symptoms</measure>
    <time_frame>After the 30 min cooling period in block 3</time_frame>
    <description>An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>POMS</measure>
    <time_frame>Immediately before exercise block 1</time_frame>
    <description>Questionnaire that indicates the current mood of the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POMS</measure>
    <time_frame>Immediately following cooling period in block 1</time_frame>
    <description>Questionnaire that indicates the current mood of the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POMS</measure>
    <time_frame>Immediately following cooling period in block 2</time_frame>
    <description>Questionnaire that indicates the current mood of the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POMS</measure>
    <time_frame>Immediately following cooling period in block 3</time_frame>
    <description>Questionnaire that indicates the current mood of the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Variability</measure>
    <time_frame>Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes), then for 5 minutes 24 hours after</time_frame>
    <description>The device used to collect HR (polar) will be used to collect heart rate variability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digits Backwards</measure>
    <time_frame>immediately before exercise block 1</time_frame>
    <description>A cognitive assessment where participants are asked to repeat a series of numbers backwards, the numbers will be read out loud by the researcher.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digits Backwards</measure>
    <time_frame>immediately following cooling block 2</time_frame>
    <description>A cognitive assessment where participants are asked to repeat a series of numbers backwards, the numbers will be read out loud by the researcher.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digits Backwards</measure>
    <time_frame>immediately following cooling block 3</time_frame>
    <description>A cognitive assessment where participants are asked to repeat a series of numbers backwards, the numbers will be read out loud by the researcher.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Purdue Peg Board test</measure>
    <time_frame>immediately before exercise block 1</time_frame>
    <description>A hand dexterity assessment that measures how quickly the participant can place a pins into a pegboard (left and right hand)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Purdue Peg Board test</measure>
    <time_frame>immediately after cooling block 2</time_frame>
    <description>A hand dexterity assessment that measures how quickly the participant can place a pins into a pegboard (left and right hand)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Purdue Peg Board test</measure>
    <time_frame>immediately after cooling block 3</time_frame>
    <description>A hand dexterity assessment that measures how quickly the participant can place a pins into a pegboard (left and right hand)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychomotor Vigilance Test</measure>
    <time_frame>immediately before exercise block 1</time_frame>
    <description>a reaction time test (on a samsung phone) where participants are asked to press the number numbers as quickly as they can</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychomotor Vigilance Test</measure>
    <time_frame>immediately after cooling block 2</time_frame>
    <description>a reaction time test (on a samsung phone) where participants are asked to press the number numbers as quickly as they can</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychomotor Vigilance Test</measure>
    <time_frame>immediately after cooling block 3</time_frame>
    <description>a reaction time test (on a samsung phone) where participants are asked to press the number numbers as quickly as they can</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digit Vigilance Test</measure>
    <time_frame>immediately before exercise block 1</time_frame>
    <description>Participants are given 2 pages of numbers and are asked to cross out all the 6's (or 9's) as quickly and accurately as they can.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digit Vigilance Test</measure>
    <time_frame>immediately after cooling block 2</time_frame>
    <description>Participants are given 2 pages of numbers and are asked to cross out all the 6's (or 9's) as quickly and accurately as they can.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digit Vigilance Test</measure>
    <time_frame>immediately after cooling block 3</time_frame>
    <description>Participants are given 2 pages of numbers and are asked to cross out all the 6's (or 9's) as quickly and accurately as they can.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trial Making Test</measure>
    <time_frame>immediately before exercise block 1</time_frame>
    <description>Participants are asked to connect as series of numbers and letters together (using a pencil)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trial Making Test</measure>
    <time_frame>immediately after cooling block 2</time_frame>
    <description>Participants are asked to connect as series of numbers and letters together (using a pencil)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trial Making Test</measure>
    <time_frame>immediately after cooling block 3</time_frame>
    <description>Participants are asked to connect as series of numbers and letters together (using a pencil)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Hyperthermia</condition>
  <arm_group>
    <arm_group_label>Cooling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be actively cooled during rest breaks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Cooling</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will participant in &quot;passive cooling&quot; where they sit in a chair during rest.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Forearm cooling</intervention_name>
    <description>forearm immersion will be performed for active cooling assessment.</description>
    <arm_group_label>Cooling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mist-fan cooling</intervention_name>
    <description>A mist-fan will be placed in front of the participant for active cooling.</description>
    <arm_group_label>Cooling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cisgender man between the ages of 18-35 years&#xD;
&#xD;
          -  been cleared by the medical monitor for this study&#xD;
&#xD;
          -  VO2max &gt; 45ml/kg/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a current musculoskeletal injury that would limit their physical activity or&#xD;
             preclude the participant from walking, jogging, running, sprinting, or cutting.&#xD;
&#xD;
          -  Chronic health problems that affect your ability to thermoregulate (disorders&#xD;
             affecting the liver, kidneys or the ability to sweat normally)&#xD;
&#xD;
          -  Fever or current illness at the time of testing&#xD;
&#xD;
          -  History of cardiovascular, metabolic, or respiratory disease&#xD;
&#xD;
          -  Current musculoskeletal injury that limits their physical activity&#xD;
&#xD;
          -  Currently taking a medication that is known to influence body temperature&#xD;
             (amphetamines, antihypertensives, anticholinergics, acetaminophen, diuretics, NSAIDs,&#xD;
             aspirin)&#xD;
&#xD;
          -  Identify as cisgender woman, transgender man or transgender woman&#xD;
&#xD;
          -  Have a history of heat related illness&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas Casa, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Connecticut</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gampel Pavilion</name>
      <address>
        <city>Storrs</city>
        <state>Connecticut</state>
        <zip>06269-1110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>December 18, 2020</last_update_submitted>
  <last_update_submitted_qc>December 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Connecticut</investigator_affiliation>
    <investigator_full_name>Douglas J Casa</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>Hyperthermia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04431596
org study id: H20-0010
nct id: NCT04431596
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
BHSAI is developing a computational system that provides early alerts of a rise in core body
      temperature to help reduce the risk of heat injury in the field and during training. The goal
      of the body temperature alerting system is to use it during rest, exercise in the heat and
      during body cooling. Using this system during cooling will allow healthcare professionals and
      military personnel monitor core temperature to ensure cooling is effective (and prevent
      hypothermia). Therefore, the primary purpose of this investigation is to validate a body
      temperature alerting system using physiological responses that occur during rest, exercise in
      the heat and during body cooling. Multiple cooling modalities will be validated. The
      effectiveness of each cooling modality (passive cooling, mist-fan cooling, hand/forearm
      immersion) on physiological variables after exercise in the heat will be assessed. Lastly,
      subject characteristics (demographic and anthropometric characteristics) will be examined to
      examine their effect on physiological variables during exercise in the heat and during body
      cooling with each cooling modality.
The study will be completed in the following timeline:

      Visit 1: Baseline and VO2max Testing Visit 2-4: Trial 1, 2 and 3

      Visit specific information is described below, however, specific data collection protocols
      for dependent variables and procedures are included below the description of the study
      design.

      Visit 1: Baseline and VO2max Testing

      Participants who are approved to participate will be scheduled for a baseline and VO2max
      testing day. Upon arrival to the lab, subjects will provide a urine sample in a clean urine
      cup. Urine specific gravity and urine color will be assessed. Nude body mass will be also be
      recorded. Privacy will be afforded for each participant while obtaining body mass measures by
      taking measurements with the participant alone in a private room behind a solid, closed door,
      and the research reading the scale outside of the room. Participants will only be permitted
      to continue to the VO2max test if the euhydrated criteria of a urine specific gravity (USG)
      <1.025 is met. If the participant arrives with a USG between 1.020 and 1.025, the subject
      will be asked to drink 500 mL of water to ensure proper hydration status. Height will be
      measured with a tape measure on Visit 1. Percent body fat will be calculated using a 7-site
      evaluation of skin fold thickness using skin fold calipers. A researcher will use appropriate
      grasping technique to measure skin fold thickness on the chest, iliac, tricep, calf,
      shoulder, abdomen, and thigh. This will take less than 5 minutes to complete. This
      information will be used to describe the subject demographics. Participants will also be
      asked to complete a maximal oxygen uptake (VO2max) test on a treadmill in a thermoneutral
      environment. This test will provide aerobic fitness levels of the participants. This visit
      will take approximately 1-2 hours.

      Visit 2-3: Trials 1, 2, 3

      Participant numbers will be randomly assigned, and trials will be ordered with a random
      number generator and assigned to a participant number. These orders will be counterbalanced
      between participants to ensure that there is not an order effect, and each participant will
      complete three trials as part of the study. Participants will be allowed to make-up trial
      visits if they are sick, suffer an injury or do not meet hydration requirements. Participants
      will be asked if they have a current illness or taking medications to determine whether they
      can complete the exercise trial. The participant's visit will be rescheduled if they have a
      fever, current illness or taking medications that influence body temperature.

      Participants will complete three trials on three separate days in a randomized counter
      balanced order:

      Trial Cooling Intervention

        1. Passive Cooling

        2. Mist-fan Cooling

        3. Forearm Immersion

      The exercise protocol and recovery portions of this study will be conducted in a climatic
      chamber with ambient temperature approximately 30-40C and relative humidity at approximately
      30-70%. Participants will drink ad libitum throughout the exercise trial.

      Upon arrival to the lab, participants will be asked to indicate if they have consumed alcohol
      or caffeine in the last 24 hours and 12 hours, respectively. They will not be asked to
      specify exactly what they have consumed, but if they provide a positive indication, their
      trial will be rescheduled for another day. Participants will provide a small urine sample in
      a clean urine cup, and a nude body mass will be measured. Upon arrival to the lab, hydration
      status will be assessed by urine specific gravity, nude body mass and urine color.
      Participants will only be permitted to continue to the exercise trial if the euhydrated
      criteria of a urine specific gravity (USG) <1.025 is met. If the participant arrives with a
      USG between 1.020 and 1.025, the subject will be asked to drink 500 mL of water to ensure
      proper hydration status. Participants will be given instructions at the prior visit about how
      to obtain desired hydration status for the upcoming trial. Participants will insert a rectal
      probe and wear a heart rate monitor strap. Additionally, participants will wear 7-site skin
      temperature sensors. Researchers will apply the skin temperature sensors with medical tape to
      the participants' chest, upper arm, thigh, neck, abdomen, thigh, back, and calf. The
      participants will also be asked to complete a subjective sleep questionnaire upon arriving to
      the lab. Participants will wear a battle dress uniform (BDU) during all exercise and rest
      blocks. Three BDU sizes for the blouse and pants (small, medium, large) will be available for
      the participants. A belt will be used to ensure the BDU fits appropriately. Participants will
      not be able to keep the BDU- BDUs will be washed (according to manufacturer's instructions)
      and re-used for participants. BDU manufacturer's instructions is identical to standard
      washing cycle (detergent and washing machine dry). Participants will wear the wrist-based
      devices (provided by BHSAI) on their non-dominant arm throughout the testing. The wrist
      device must be placed approximately 1-inch proximal to the wrist and be fitted snuggly for
      accurate heart-rate measurements. The wrist device is used to estimate heart rate using
      infrared technology. The wrist device estimates of heart rate will be compared to the polar
      heart rate monitor (gold standard). The body alerting system uses heart rate from the wrist
      device and the environmental conditions to estimate body temperature. The sponsor of the
      study will use rectal temperature and the 7-site skin temperature sensors to alter the
      algorithm (not in real time- from the collected data) to better estimate body temperature.
      The future goal is to have the body alerting system imbedded in the watch.

      Participants will enter the environmental chamber and sit for 30 minutes to become
      equilibrated. The environmental chamber will be set to 36C ambient temperature, 30% relative
      humidity After baseline measures of heart rate, rectal temperature, participants will
      complete the perceptual indices. Participants will also complete an environmental symptoms
      questionnaire (ESQ).

      The trial will consist of three, 50-minute intervals of walking and running at approximately
      30-50% of VO2max and 60-80% of VO2max, respectively. Each 50-minute exercise block with be
      followed by a 30-minute break where cooling will occur. Participants will be allowed to drink
      ad libitum throughout the exercise trial. The participant will be cooled for approximately 30
      minutes with their assigned cooling modality. Rectal temperature, skin temperature, heart
      rate, perceptual measures, and mood will be collected at various time points before, during,
      and after exercise and cooling.

      Passive Cooling: Participants will be asked to sit in a chair in the climate chamber for
      passive cooling.

      Mist-fan cooling: A mist-fan will be placed in front of the participant during mist-fan
      cooling. Participants will be asked to roll up their BDU sleeves to increase skin surface
      area. The temperature of the mist and wind speed of the fan will be recorded.

      Forearm immersion: The participant will place their forearm in approximately 20C water during
      forearm immersion.

      Data collection will be divided into two separate phases. A pilot study will be first
      conducted in which the first two participants will complete all study laboratory visits. Data
      from those trials will be shared with the sponsor for review before continuation of data
      collection.

      Participants will undergo the same procedures for the pilot testing as regular testing. Pilot
      testing data will be included in the dataset. Following approval from the sponsor, data
      collection will resume. Each trial will be approximately 4-5 hours.

      All devices will be properly cleaned according to manufacturer's instruction prior to use by
      other participants.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: Participants receive three cooling treatments on separate study visits: 1) passive cooling 2) mist-fan cooling and 3) forearm immersion cooling
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Rectal Temperature
time frame: Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)
description: Rectal thermometer will be self-inserted by participant to assess core temperature
measure: Change in Mean Skin Temperature
time frame: Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)
description: 7 skin temperature sensors will be placed on the subject (neck, chest, shoulder,back, abdomen, thigh, calf)
measure: Change in Heart Rate
time frame: Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)
description: A heart rate monitor will be worn by participant throughout exercise/cooling protocol
measure: Change in Rating of Perceived Exertion (RPE)
time frame: Measured every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)
description: 6-20 scale that indicates how hard the participant feels they are working. 6 represents rest and 20 represents maximal exertion. A high score indicates more perceived exertion.
measure: Change in Thermal Sensation (TS)
time frame: Measured every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)
description: 0-8 Scale (cold to hot) that indicated how cold or hot the participate feels. 0 = extremely cold, 8 = extremely hot.
measure: Change in Perception of Fatigue
time frame: Measured every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)
description: 0-10 (no fatigue to extreme fatigue) Scale that indicates how fatigued the participate feels. High score indicates more fatigue (negative outcome).
measure: Change in Perception of Thirst
time frame: Measured every 10 minutes during 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes)
description: 0-9 (no thirst to extreme thirst) Scale that indicates how thirsty the subject feels. A higher score is considered a negative outcome.
measure: Environmental Symptoms
time frame: Before the start of exercise block 1
description: An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable)
measure: Environmental Symptoms
time frame: After the 30 min cooling period in block 3
description: An environmental symptoms questionnaire to indicate they feel (hot, lethargic, irritable)
measure: POMS
time frame: Immediately before exercise block 1
description: Questionnaire that indicates the current mood of the participant
measure: POMS
time frame: Immediately following cooling period in block 1
description: Questionnaire that indicates the current mood of the participant
measure: POMS
time frame: Immediately following cooling period in block 2
description: Questionnaire that indicates the current mood of the participant
measure: POMS
time frame: Immediately following cooling period in block 3
description: Questionnaire that indicates the current mood of the participant
measure: Heart Rate Variability
time frame: Measured continuously for 50 min exercise block 1, 30 min cooling period block 1, 50 min exercise block 2, 30 min cooling period block 2, 50 min exercise block 3, 30 min cooling period block 3 (total 240 minutes), then for 5 minutes 24 hours after
description: The device used to collect HR (polar) will be used to collect heart rate variability
measure: Digits Backwards
time frame: immediately before exercise block 1
description: A cognitive assessment where participants are asked to repeat a series of numbers backwards, the numbers will be read out loud by the researcher.
measure: Digits Backwards
time frame: immediately following cooling block 2
description: A cognitive assessment where participants are asked to repeat a series of numbers backwards, the numbers will be read out loud by the researcher.
measure: Digits Backwards
time frame: immediately following cooling block 3
description: A cognitive assessment where participants are asked to repeat a series of numbers backwards, the numbers will be read out loud by the researcher.
measure: Purdue Peg Board test
time frame: immediately before exercise block 1
description: A hand dexterity assessment that measures how quickly the participant can place a pins into a pegboard (left and right hand)
measure: Purdue Peg Board test
time frame: immediately after cooling block 2
description: A hand dexterity assessment that measures how quickly the participant can place a pins into a pegboard (left and right hand)
measure: Purdue Peg Board test
time frame: immediately after cooling block 3
description: A hand dexterity assessment that measures how quickly the participant can place a pins into a pegboard (left and right hand)
measure: Psychomotor Vigilance Test
time frame: immediately before exercise block 1
description: a reaction time test (on a samsung phone) where participants are asked to press the number numbers as quickly as they can
measure: Psychomotor Vigilance Test
time frame: immediately after cooling block 2
description: a reaction time test (on a samsung phone) where participants are asked to press the number numbers as quickly as they can
measure: Psychomotor Vigilance Test
time frame: immediately after cooling block 3
description: a reaction time test (on a samsung phone) where participants are asked to press the number numbers as quickly as they can
measure: Digit Vigilance Test
time frame: immediately before exercise block 1
description: Participants are given 2 pages of numbers and are asked to cross out all the 6's (or 9's) as quickly and accurately as they can.
measure: Digit Vigilance Test
time frame: immediately after cooling block 2
description: Participants are given 2 pages of numbers and are asked to cross out all the 6's (or 9's) as quickly and accurately as they can.
measure: Digit Vigilance Test
time frame: immediately after cooling block 3
description: Participants are given 2 pages of numbers and are asked to cross out all the 6's (or 9's) as quickly and accurately as they can.
measure: Trial Making Test
time frame: immediately before exercise block 1
description: Participants are asked to connect as series of numbers and letters together (using a pencil)
measure: Trial Making Test
time frame: immediately after cooling block 2
description: Participants are asked to connect as series of numbers and letters together (using a pencil)
measure: Trial Making Test
time frame: immediately after cooling block 3
description: Participants are asked to connect as series of numbers and letters together (using a pencil)
arm group label: Cooling
arm group type: Active Comparator
description: Participants will be actively cooled during rest breaks.
arm group label: No Cooling
arm group type: No Intervention
description: Participants will participant in "passive cooling" where they sit in a chair during rest.
intervention type: Device
intervention name: Forearm cooling
description: forearm immersion will be performed for active cooling assessment.
arm group label: Cooling
intervention type: Other
intervention name: Mist-fan cooling
description: A mist-fan will be placed in front of the participant for active cooling.
arm group label: Cooling
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Douglas Casa, PhD
role: Principal Investigator
affiliation: University of Connecticut
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Connecticut
investigator full name: Douglas J Casa
investigator title: Professor
mesh term: Hyperthermia