<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/NCT03229109</url>
  </required_header>
  <id_info>
    <org_study_id>04/17</org_study_id>
    <nct_id>NCT03229109</nct_id>
  </id_info>
  <brief_title>Analysis of Sweat Secretion and Body Dehydration Monitoring</brief_title>
  <official_title>Spectrophon Dehydration Body Monitor Accuracy Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tirat Carmel Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ariel University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tirat Carmel Mental Health Center</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>
      Monitoring of a person's physical status is a key point for maintaining of &quot;healthy life&quot;.&#xD;
      Wearable devices provide a unique possibility for real-time monitoring. This study aims to&#xD;
      estimate the accuracy of Spectrophon Dehydration Body Monitor (DBM) incorporated in&#xD;
      smartwatch Samsung Gear S2 and sport band Samsung Gear Fit2 by comparing data obtained by DBM&#xD;
      with the total weight lost during exertion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reduced physical activity is considered as a risk factor for obesity, diabetes, cancer and&#xD;
      depression. A proper exercise program can mitigate cognitive and physical decline associated&#xD;
      with ageing. Existing general guidelines for physical activity are not universal or&#xD;
      appropriate for every person. A personalized approach based on a subject age and unique&#xD;
      combination of different physiological parameters would serve as a solution for finding&#xD;
      optimal training protocols for individuals. Hence, monitoring basic physiological and&#xD;
      biochemical parameters and obtaining information reflecting the body metabolic state is&#xD;
      necessary for health status estimation to develop the abovementioned personally-oriented&#xD;
      training protocols. Dehydration Body Monitor (DBM) developed by Spectrophon L.T.D. can&#xD;
      measure sweat lost, salt concentration in sweat, and sweating dynamics, which can be used for&#xD;
      personal physical status monitoring. This is important not only for controlling appropriate&#xD;
      body hydration level but also for keeping kidneys &quot;healthy&quot;. Currently, only few DBM tools&#xD;
      are available on the market, so there is a growing need for new effective accurate real-time&#xD;
      DBM sensors.&#xD;
&#xD;
      The main objective of current study is to estimate the accuracy of Spectrophon DBM&#xD;
      incorporated in smartwatch Samsung Gear S2 and sport band Samsung Gear Fit2. The secondary&#xD;
      aim of the study is to evaluate the safety-in-use of Spectrophon DBM.&#xD;
&#xD;
      Tested device:&#xD;
&#xD;
      Name: Dehydration Body Monitor; Source: Spectrophon, L.T.D.; Model: SP-DBM Firmware version:&#xD;
      1.5&#xD;
&#xD;
      4. Experimental Design Healthy adults (n=200) in different age and gender groups were&#xD;
      recruited for the study. Samsung Gear S2 smartwatch with Spectrophon DBM attached to the&#xD;
      bottom of the smartwatch were placed on the right wrist of each participant. At the same&#xD;
      time, Samsung Gear Fit2 sport band with Spectrophon DBM attached to the bottom of the band&#xD;
      was placed on the left wrist of the participant. Each participant was subjected to moderate&#xD;
      physical activity. Data from Samsung Gear S2 and Samsung Gear Fit2 was obtained&#xD;
      simultaneously. In parallel, subject weight was also monitored using commercially available&#xD;
      digital balancers (Shekel B-200-P).&#xD;
&#xD;
      The evaluation of the measurement accuracy of the Spectrophon DBM was defined as the&#xD;
      difference between subject weight change during the exertion (due to sweating and water&#xD;
      consumption) and the volume of sweat detected by Spectrophon DBM.&#xD;
&#xD;
      5. Procedures: Participants were weighed prior to the experiment (no clothing after maximal&#xD;
      drying) and then subjected to physical activity (walking on the treadmill).&#xD;
&#xD;
      Total duration of study: 90 minutes&#xD;
&#xD;
      5.2 Intensity of exercises:&#xD;
&#xD;
      Participants could choose high or low intensity of exertion:&#xD;
&#xD;
        1. High: up to 6.5km/h;&#xD;
&#xD;
        2. Low: yo to 6.0km/h; 5.3 Data recording: After DBM application was activated, DBM started&#xD;
           recording data (sweat rate and total salt in sweat) every 20 sec. and automatically&#xD;
           saved results into archive on a mobile phone linked to Samsung Gear S2 or Samsung Gear&#xD;
           Fit2 by Bluetooth. Manual recording of data was conducted during breaks Participants&#xD;
           were also weighed during each break (no clothing after maximal drying).&#xD;
&#xD;
      5.4. Drinking During the procedure, subjects could drink up to 500 ml of water. The weight of&#xD;
      the bottle was measured and recorded after drinking during breaks. The difference was&#xD;
      subtracted to the weight loss calculation.&#xD;
&#xD;
      5.5 Restrictions:&#xD;
&#xD;
      In this experiment, the following was avoided:&#xD;
&#xD;
        1. Urination during test (empty before T0)&#xD;
&#xD;
        2. Weight loss should not exceed 2%&#xD;
&#xD;
      Participants could cancel the experiment at any point of the procedure if desired.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2017</start_date>
  <completion_date type="Actual">July 27, 2017</completion_date>
  <primary_completion_date type="Actual">July 27, 2017</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>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Measurements Grouped by Level or Error</measure>
    <time_frame>90 minutes</time_frame>
    <description>Number of measurements obtained with Dehydration Monitor with errors greater/less than 20% (as compared to Shekel B-200-P)</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">201</enrollment>
  <condition>Dehydration</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spectrophon dehydration body monitor</intervention_name>
    <description>Participants (both males and females) were assigned to physical activity (running), biosensor was attached to subject's wrist</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: older than 18, both gender.&#xD;
&#xD;
          2. Ability and willingness to sign an informed consent form for participation in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of cardiologic or vascular disease.&#xD;
&#xD;
          2. Evidence of any other serious medical disorder.&#xD;
&#xD;
          3. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anatoly Kreinin, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bruce Rappaport Medical Faculty, Technion, Haifa, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mental Health Center</name>
      <address>
        <city>Tirat Karmel</city>
        <state>Haifa</state>
        <zip>30200</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tirat Carmel Mental Health Center</name>
      <address>
        <city>Tirat Karmel</city>
        <state>Haifa</state>
        <zip>30200</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement. Diabetes Care. 2010 Dec;33(12):e147-67. doi: 10.2337/dc10-9990.</citation>
    <PMID>21115758</PMID>
  </reference>
  <reference>
    <citation>Craft LL, Perna FM. The Benefits of Exercise for the Clinically Depressed. Prim Care Companion J Clin Psychiatry. 2004;6(3):104-111. doi: 10.4088/pcc.v06n0301.</citation>
    <PMID>15361924</PMID>
  </reference>
  <reference>
    <citation>Sternfeld B, Weltzien E, Quesenberry CP Jr, Castillo AL, Kwan M, Slattery ML, Caan BJ. Physical activity and risk of recurrence and mortality in breast cancer survivors: findings from the LACE study. Cancer Epidemiol Biomarkers Prev. 2009 Jan;18(1):87-95. doi: 10.1158/1055-9965.EPI-08-0595.</citation>
    <PMID>19124485</PMID>
  </reference>
  <reference>
    <citation>Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.</citation>
    <PMID>16534088</PMID>
  </reference>
  <reference>
    <citation>Anastasio P, Cirillo M, Spitali L, Frangiosa A, Pollastro RM, De Santo NG. Level of hydration and renal function in healthy humans. Kidney Int. 2001 Aug;60(2):748-56. doi: 10.1046/j.1523-1755.2001.060002748.x.</citation>
    <PMID>11473658</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <results_first_submitted>November 12, 2017</results_first_submitted>
  <results_first_submitted_qc>October 30, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 31, 2019</results_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tirat Carmel Mental Health Center</investigator_affiliation>
    <investigator_full_name>Anatoly Kreinin, MD, PHD</investigator_full_name>
    <investigator_title>Head of Psychiatry Department,</investigator_title>
  </responsible_party>
  <keyword>dehydration</keyword>
  <keyword>spectrophon</keyword>
  <keyword>device</keyword>
  <keyword>perspiration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dehydration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03229109/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group 1</title>
          <description>Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
        </group>
        <group group_id="P2">
          <title>Group 2</title>
          <description>Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
        </group>
        <group group_id="P3">
          <title>Group 3</title>
          <description>Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
        </group>
        <group group_id="P4">
          <title>Group 4</title>
          <description>Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
                <participants group_id="P3" count="50"/>
                <participants group_id="P4" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
                <participants group_id="P3" count="50"/>
                <participants group_id="P4" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Not relevant</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1</title>
          <description>Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
        </group>
        <group group_id="B2">
          <title>Group 2</title>
          <description>Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
        </group>
        <group group_id="B3">
          <title>Group 3</title>
          <description>Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
        </group>
        <group group_id="B4">
          <title>Group 4</title>
          <description>Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="50"/>
            <count group_id="B4" value="51"/>
            <count group_id="B5" value="201"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="51"/>
                    <count group_id="B5" value="201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="51"/>
                    <measurement group_id="B5" value="201"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="51"/>
                    <count group_id="B5" value="201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Israel</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="50"/>
                    <count group_id="B4" value="51"/>
                    <count group_id="B5" value="201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="51"/>
                    <measurement group_id="B5" value="201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Measurements Grouped by Level or Error</title>
        <description>Number of measurements obtained with Dehydration Monitor with errors greater/less than 20% (as compared to Shekel B-200-P)</description>
        <time_frame>90 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
          </group>
          <group group_id="O4">
            <title>Group 4</title>
            <description>Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Measurements Grouped by Level or Error</title>
          <description>Number of measurements obtained with Dehydration Monitor with errors greater/less than 20% (as compared to Shekel B-200-P)</description>
          <units>Number of measurements</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="50"/>
                <count group_id="O4" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Samsung Gear S2 : &lt;20% errors in measurements</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="49"/>
                    <measurement group_id="O4" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Samsung Gear S2 : &gt;20% errors in measurements</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Samsung Gear Fit2 : &lt;20% errors in measurements</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="46"/>
                    <measurement group_id="O4" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Samsung Gear Fit2 : &gt;20% errors in measurements</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>90 minutes</time_frame>
      <desc>The trial did not involve any invasive treatments or administration of any medications so no serious adverse events were monitored, which explains why the number of participants at risk for Serious Adverse Events and for All-Cause Mortality is zero.&#xD;
However, we asked participants to report any discomfort (e.g. allergic reactions) at the place where Samsung watch or band with DBM were worn.</desc>
      <group_list>
        <group group_id="E1">
          <title>Age 18-25</title>
          <description>Spectrophon dehydration body monitor was attached to subject's wrist</description>
        </group>
        <group group_id="E2">
          <title>Age 26-35</title>
          <description>Spectrophon dehydration body monitor was attached to subject's wrist</description>
        </group>
        <group group_id="E3">
          <title>Age 36-45</title>
          <description>Spectrophon dehydration body monitor was attached to subject's wrist</description>
        </group>
        <group group_id="E4">
          <title>Age 46-50</title>
          <description>Spectrophon dehydration body monitor was attached to subject's wrist</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Anatoly Kreinin</name_or_title>
      <organization>Maale Carmel Mental Health Center</organization>
      <phone>(+972) -4-8559315</phone>
      <email>kranata@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03229109
org study id: 04/17
nct id: NCT03229109
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Monitoring of a person's physical status is a key point for maintaining of "healthy life".
      Wearable devices provide a unique possibility for real-time monitoring. This study aims to
      estimate the accuracy of Spectrophon Dehydration Body Monitor (DBM) incorporated in
      smartwatch Samsung Gear S2 and sport band Samsung Gear Fit2 by comparing data obtained by DBM
      with the total weight lost during exertion.
Reduced physical activity is considered as a risk factor for obesity, diabetes, cancer and
      depression. A proper exercise program can mitigate cognitive and physical decline associated
      with ageing. Existing general guidelines for physical activity are not universal or
      appropriate for every person. A personalized approach based on a subject age and unique
      combination of different physiological parameters would serve as a solution for finding
      optimal training protocols for individuals. Hence, monitoring basic physiological and
      biochemical parameters and obtaining information reflecting the body metabolic state is
      necessary for health status estimation to develop the abovementioned personally-oriented
      training protocols. Dehydration Body Monitor (DBM) developed by Spectrophon L.T.D. can
      measure sweat lost, salt concentration in sweat, and sweating dynamics, which can be used for
      personal physical status monitoring. This is important not only for controlling appropriate
      body hydration level but also for keeping kidneys "healthy". Currently, only few DBM tools
      are available on the market, so there is a growing need for new effective accurate real-time
      DBM sensors.

      The main objective of current study is to estimate the accuracy of Spectrophon DBM
      incorporated in smartwatch Samsung Gear S2 and sport band Samsung Gear Fit2. The secondary
      aim of the study is to evaluate the safety-in-use of Spectrophon DBM.

      Tested device:

      Name: Dehydration Body Monitor; Source: Spectrophon, L.T.D.; Model: SP-DBM Firmware version:
      1.5

      4. Experimental Design Healthy adults (n=200) in different age and gender groups were
      recruited for the study. Samsung Gear S2 smartwatch with Spectrophon DBM attached to the
      bottom of the smartwatch were placed on the right wrist of each participant. At the same
      time, Samsung Gear Fit2 sport band with Spectrophon DBM attached to the bottom of the band
      was placed on the left wrist of the participant. Each participant was subjected to moderate
      physical activity. Data from Samsung Gear S2 and Samsung Gear Fit2 was obtained
      simultaneously. In parallel, subject weight was also monitored using commercially available
      digital balancers (Shekel B-200-P).

      The evaluation of the measurement accuracy of the Spectrophon DBM was defined as the
      difference between subject weight change during the exertion (due to sweating and water
      consumption) and the volume of sweat detected by Spectrophon DBM.

      5. Procedures: Participants were weighed prior to the experiment (no clothing after maximal
      drying) and then subjected to physical activity (walking on the treadmill).

      Total duration of study: 90 minutes

      5.2 Intensity of exercises:

      Participants could choose high or low intensity of exertion:

        1. High: up to 6.5km/h;

        2. Low: yo to 6.0km/h; 5.3 Data recording: After DBM application was activated, DBM started
           recording data (sweat rate and total salt in sweat) every 20 sec. and automatically
           saved results into archive on a mobile phone linked to Samsung Gear S2 or Samsung Gear
           Fit2 by Bluetooth. Manual recording of data was conducted during breaks Participants
           were also weighed during each break (no clothing after maximal drying).

      5.4. Drinking During the procedure, subjects could drink up to 500 ml of water. The weight of
      the bottle was measured and recorded after drinking during breaks. The difference was
      subtracted to the weight loss calculation.

      5.5 Restrictions:

      In this experiment, the following was avoided:

        1. Urination during test (empty before T0)

        2. Weight loss should not exceed 2%

      Participants could cancel the experiment at any point of the procedure if desired.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Number of Measurements Grouped by Level or Error
time frame: 90 minutes
description: Number of measurements obtained with Dehydration Monitor with errors greater/less than 20% (as compared to Shekel B-200-P)
arm group label: Group 1
arm group type: Experimental
description: Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
arm group label: Group 2
arm group type: Experimental
description: Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
arm group label: Group 3
arm group type: Experimental
description: Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
arm group label: Group 4
arm group type: Experimental
description: Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist
intervention type: Device
intervention name: Spectrophon dehydration body monitor
description: Participants (both males and females) were assigned to physical activity (running), biosensor was attached to subject's wrist
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anatoly Kreinin, MD, PHD
role: Principal Investigator
affiliation: Bruce Rappaport Medical Faculty, Technion, Haifa, Israel
facility: 
facility: 
country: Israel
citation: Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement. Diabetes Care. 2010 Dec;33(12):e147-67. doi: 10.2337/dc10-9990.
PMID: 21115758
citation: Craft LL, Perna FM. The Benefits of Exercise for the Clinically Depressed. Prim Care Companion J Clin Psychiatry. 2004;6(3):104-111. doi: 10.4088/pcc.v06n0301.
PMID: 15361924
citation: Sternfeld B, Weltzien E, Quesenberry CP Jr, Castillo AL, Kwan M, Slattery ML, Caan BJ. Physical activity and risk of recurrence and mortality in breast cancer survivors: findings from the LACE study. Cancer Epidemiol Biomarkers Prev. 2009 Jan;18(1):87-95. doi: 10.1158/1055-9965.EPI-08-0595.
PMID: 19124485
citation: Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.
PMID: 16534088
citation: Anastasio P, Cirillo M, Spitali L, Frangiosa A, Pollastro RM, De Santo NG. Level of hydration and renal function in healthy humans. Kidney Int. 2001 Aug;60(2):748-56. doi: 10.1046/j.1523-1755.2001.060002748.x.
PMID: 11473658
responsible party type: Principal Investigator
investigator affiliation: Tirat Carmel Mental Health Center
investigator full name: Anatoly Kreinin, MD, PHD
investigator title: Head of Psychiatry Department,
mesh term: Dehydration
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 