<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/NCT02206581</url>
  </required_header>
  <id_info>
    <org_study_id>HME-01</org_study_id>
    <secondary_id>2R44AG042990</secondary_id>
    <nct_id>NCT02206581</nct_id>
  </id_info>
  <brief_title>Using Hydration Monitor to Detect Changes in the Hydration Status Athletes</brief_title>
  <official_title>The Validity of Ultrasound Velocity to Detect Changes in the Hydration Status of Male and Female Athletes During Acute Dehydration and Rehydration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Artann Laboratories</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Appalachian State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Artann Laboratories</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will aim to evaluate the correlation between changes in ultrasound velocity and&#xD;
      measures of hydration status including urine specific gravity, plasma and urine osmolality in&#xD;
      male and female young adults after undergoing an acute dehydration and rehydration. The study&#xD;
      will also test the hypothesis that body dehydration is a generalized physiological process&#xD;
      equally affected all body muscles by comparing the data obtained on calf and biceps muscles.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To observe statistically significant changes in ultrasound velocity associated with acute dehydration</measure>
    <time_frame>2 hours</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">82</enrollment>
  <condition>Dehydration</condition>
  <arm_group>
    <arm_group_label>young healthy adult athletes</arm_group_label>
    <description>Hydration Monitor measurement of the ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing 3% acute dehydration and a 2-hr rehydration period</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hydration Monitor</intervention_name>
    <arm_group_label>young healthy adult athletes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The subject pool will be comprised of 100 young, healthy, physically active male and female&#xD;
        subjects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female athletes&#xD;
&#xD;
          -  ages 18-25 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  open wounds or rashes on calf testing area&#xD;
&#xD;
          -  active skin infection&#xD;
&#xD;
          -  pregnant female subjects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Appalachian State University</name>
      <address>
        <city>Boone</city>
        <state>North Carolina</state>
        <zip>28608-2071</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>January 20, 2016</last_update_submitted>
  <last_update_submitted_qc>January 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dehydration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dehydration</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/NCT02206581
org study id: HME-01
secondary id: 2R44AG042990
nct id: NCT02206581
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The study will aim to evaluate the correlation between changes in ultrasound velocity and
      measures of hydration status including urine specific gravity, plasma and urine osmolality in
      male and female young adults after undergoing an acute dehydration and rehydration. The study
      will also test the hypothesis that body dehydration is a generalized physiological process
      equally affected all body muscles by comparing the data obtained on calf and biceps muscles.
observational model: Case-Only
time perspective: Cross-Sectional
measure: To observe statistically significant changes in ultrasound velocity associated with acute dehydration
time frame: 2 hours
arm group label: young healthy adult athletes
description: Hydration Monitor measurement of the ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing 3% acute dehydration and a 2-hr rehydration period
intervention type: Device
intervention name: Hydration Monitor
arm group label: young healthy adult athletes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dehydration