<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/NCT02206633</url>
  </required_header>
  <id_info>
    <org_study_id>HME-02</org_study_id>
    <secondary_id>2R44AG042990</secondary_id>
    <nct_id>NCT02206633</nct_id>
  </id_info>
  <brief_title>Hydration Monitor Validation in Elderly</brief_title>
  <official_title>The Validity of Ultrasound Velocity to Assess Hydration Status of Elderly Residing in Assisted Living Facilities</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 determine normal daily variation of the individual hydration level in&#xD;
      longitudinal study on elderly in assisted living facility and assess a range of variation of&#xD;
      individual hydration baselines for elderly in a normal physiologically hydrated state.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subject pool will be comprised of 100 elderly (over 65 years old), male and female&#xD;
      subjects who are residing in assisted living center. All subjects will provide written&#xD;
      informed consent before participation. For the day prior testing and all testing days&#xD;
      subjects will be encouraged to follow standard hydration guidelines for older adults by&#xD;
      consuming 1200-2400 ml/day depending upon the body weight of subjects. The application of the&#xD;
      HM will follow specific protocol based on the prototype HM user manual for specific anatomic&#xD;
      locations. Triplicate measurements will be made for each time-point. All subjects will also&#xD;
      be measured for bioelectrical impedance analysis (BIA) and estimation of total body water&#xD;
      using a leg-to-leg BIA machine. To examine within-day and between-day variability and&#xD;
      reliability of the HM a subgroup (N=25) of the 100 initial subjects will be selected.&#xD;
      Within-day reliability will be evaluated by taking multiple measurements (3) during the day.&#xD;
      Between-day reliability will include measurements (same time) for three consecutive days for&#xD;
      the subgroup of 25 subjects. BIA measures will also be included during each of the time&#xD;
      points for both within-day and between-day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">June 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 normal daily variation of the individual hydration level of elderly</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">73</enrollment>
  <condition>Dehydration</condition>
  <arm_group>
    <arm_group_label>Elderly, assisted living residents</arm_group_label>
    <description>Hydration Monitor ultrasound measurements</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hydration Monitor</intervention_name>
    <description>Measurement of the ultrasound velocity with the Hydration Monitor for specific anatomic locations. Triplicate measurements will be made for each time-point. All subjects will also be measured for bioelectrical impedance analysis (BIA) and estimation of total body water using a leg-to-leg BIA machine.</description>
    <arm_group_label>Elderly, assisted living residents</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The subject pool will be comprised of 100 elderly (over 65 years old), male and female&#xD;
        subjects who are residing in assisted living center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elderly ( above 65 years old)&#xD;
&#xD;
          -  male and female subjects who is residing in assisted living centers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Open wounds or rashes on calf testing area&#xD;
&#xD;
          -  Visibly detectable edema&#xD;
&#xD;
          -  Active skin infection&#xD;
&#xD;
          -  Subjects will be excluded from the study if they can't physically stand on both feet&#xD;
             without assistance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Armen Sarvazyan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CSO, Artann Laboratories</affiliation>
  </overall_official>
  <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>November 2014</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>June 22, 2015</last_update_submitted>
  <last_update_submitted_qc>June 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 23, 2015</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/NCT02206633
org study id: HME-02
secondary id: 2R44AG042990
nct id: NCT02206633
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The study will aim to determine normal daily variation of the individual hydration level in
      longitudinal study on elderly in assisted living facility and assess a range of variation of
      individual hydration baselines for elderly in a normal physiologically hydrated state.
The subject pool will be comprised of 100 elderly (over 65 years old), male and female
      subjects who are residing in assisted living center. All subjects will provide written
      informed consent before participation. For the day prior testing and all testing days
      subjects will be encouraged to follow standard hydration guidelines for older adults by
      consuming 1200-2400 ml/day depending upon the body weight of subjects. The application of the
      HM will follow specific protocol based on the prototype HM user manual for specific anatomic
      locations. Triplicate measurements will be made for each time-point. All subjects will also
      be measured for bioelectrical impedance analysis (BIA) and estimation of total body water
      using a leg-to-leg BIA machine. To examine within-day and between-day variability and
      reliability of the HM a subgroup (N=25) of the 100 initial subjects will be selected.
      Within-day reliability will be evaluated by taking multiple measurements (3) during the day.
      Between-day reliability will include measurements (same time) for three consecutive days for
      the subgroup of 25 subjects. BIA measures will also be included during each of the time
      points for both within-day and between-day.
observational model: Case-Only
time perspective: Cross-Sectional
measure: To observe statistically significant changes in ultrasound velocity associated with normal daily variation of the individual hydration level of elderly
time frame: 1 day
arm group label: Elderly, assisted living residents
description: Hydration Monitor ultrasound measurements
intervention type: Device
intervention name: Hydration Monitor
description: Measurement of the ultrasound velocity with the Hydration Monitor for specific anatomic locations. Triplicate measurements will be made for each time-point. All subjects will also be measured for bioelectrical impedance analysis (BIA) and estimation of total body water using a leg-to-leg BIA machine.
arm group label: Elderly, assisted living residents
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Armen Sarvazyan, PhD
role: Principal Investigator
affiliation: CSO, Artann Laboratories
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dehydration