<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/NCT03792893</url>
  </required_header>
  <id_info>
    <org_study_id>ERG_03</org_study_id>
    <nct_id>NCT03792893</nct_id>
  </id_info>
  <brief_title>Comparison of Pulse Wave and Blood Pressure Measurements Before, During and After Ergometry in Healthy Women</brief_title>
  <official_title>Comparison of Pulse Wave and Blood Pressure Parameters Before, During and After Exercise Ergometry in Healthy Female Subjects - a Randomized, Controlled, Single-blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ARCIM Institute Academic Research in Complementary and Integrative Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universität Tübingen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ARCIM Institute Academic Research in Complementary and Integrative Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this randomized, controlled single blind study is to compare pulse wave and&#xD;
      blood pressure measurements before, during and after exercise ergometry in healthy female&#xD;
      subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a randomized single-blind study design the investigators explore how well blood pressure&#xD;
      parameters calculated using a Pulse Transit Time-based method (device: SOMNOtouchTM RESP)&#xD;
      match blood pressure parameters measured by a classic upper arm blood pressure cuff&#xD;
      (BOSO-TM-2430 ) under standardized load conditions (ergometry).&#xD;
&#xD;
      In 30 healthy female subjects (age 18 - 40 years), cardiovascular parameters before, during&#xD;
      and after a standardized load on a bicycle ergometer (half-lying position) are recorded with&#xD;
      three different devices (BOSO-TM-2430 versus SOMNOtouchTM RESP versus GeTeMed Vitaguard 3100)&#xD;
      and compared.&#xD;
&#xD;
      Primary outcome is the difference of the systolic blood pressure values between the devices&#xD;
      BOSO-TM-2430 versus SOMNOtouchTM RESP during the three phases.&#xD;
&#xD;
      The BOSO-TM-2430 blood pressure cuff is applied randomized to the arm with the previously&#xD;
      determined higher or lower systolic blood pressure mean difference. The subjects are blinded&#xD;
      to the results of the measurements during ergometry.&#xD;
&#xD;
      After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer&#xD;
      for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase&#xD;
      every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest period.&#xD;
      Measurements are taken every two minutes with the BOSO-TM-2430; data acquisition with the&#xD;
      SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 devices takes place continuously over a total&#xD;
      duration of 72 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Actual">May 17, 2019</completion_date>
  <primary_completion_date type="Actual">May 17, 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference of the systolic blood pressure</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Primary outcome is the difference of the systolic blood pressure values between the devices BOSO-TM-2430 versus SOMNOtouchTM RESP during the three phases</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure (SOMNOtouchTM RESP)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Diastolic Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Arterial Blood Pressure (SOMNOtouchTM RESP)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Mean Arterial Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse Pressure (SOMNOtouchTM RESP)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Pulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heartrate (SOMNOtouchTM RESP)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Heartrate (beats per minute, bpm) measured with the SOMNOtouchTM RESP device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation (SpO2, SOMNOtouchTM RESP)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Oxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse-Transit-Time (PTT, SOMNOtouchTM RESP)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure measured with the device BOSO-TM-2430</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Systolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure measured with the device BOSO-TM-2430</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Diastolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Arterial Blood Pressure measured with the device BOSO-TM-2430</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Mean Arterial Blood Pressure (mmHg) measured with the BOSO-TM-2430 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse Pressure measured with the device BOSO-TM-2430</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Pulse Pressure (mmHg) measured with the BOSO-TM-2430 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heartrate measured with the device BOSO-TM-2430</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Heartrate (beats per minute, bpm) measured with the BOSO-TM-2430 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse Transit Time (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Pulse Transit Time (PTT, ms) measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perfusion Index (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Perfusion Index (PI) measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak to Peak Time (PPT) (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SlopeInW1 (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>SlopeInW1 measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SlopeInW2 (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>SlopeInW2 measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SlopeInW3 (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>SlopeInW3 measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SlopeInW4 (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>SlopeInW4 measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>StiffnessIndex (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>StiffnessIndex measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ReflectionIndex (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>ReflectionIndex measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TimeTX (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>TimeTX (ms) measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TimeTY (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>TimeTY (ms) measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QuotTYTX (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>QuotTYTX measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AreaAX (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>AreaAX measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AreaAY (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>AreaAY measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QuotAYAX (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>QuotAYAX measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AreaAV (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>AreaAV measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AreaAW (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>AreaAW measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QuotAWAV (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>QuotAWAV measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QuotTVTW (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>QuotTVTW measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TimeTV (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>TimeTV (ms) measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TimeTW (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>TimeTW (ms) measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MinT1 (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the first peak</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MinT2 (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MaxT1 (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the first peak</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MaxT2 (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the second peak</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QuotHRRespRate (GeTeMed Vitaguard 3100)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes</time_frame>
    <description>Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy Female Subjects</condition>
  <arm_group>
    <arm_group_label>Higher Blood Pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure. Intervention: Ergometry H</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lower Blood Pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure. Intervention: Ergometry L</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ergometry H</intervention_name>
    <description>After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest periodmaximum load of 180 watts), followed by a 15-minute post-rest period.&#xD;
BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure (reference parameter).&#xD;
SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined lower systolic blood pressure.</description>
    <arm_group_label>Higher Blood Pressure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ergometry L</intervention_name>
    <description>After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest periodmaximum load of 180 watts), followed by a 15-minute post-rest period.&#xD;
BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure (reference parameter).&#xD;
SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined higher systolic blood pressure.</description>
    <arm_group_label>Lower Blood Pressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Healthy at the time of the examinations&#xD;
&#xD;
          -  Inconspicuous anamnesis regarding cardiovascular diseases and bronchial asthma&#xD;
&#xD;
          -  resting heart rate 50 to 100 beats per minute&#xD;
&#xD;
          -  Normal blood pressure or appropriately treated and controlled hypertension (systolic&#xD;
             blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute or chronic (especially cardiovascular) diseases, including cardiac arrhythmia&#xD;
             and vegetative regulatory disorders (recorded via anamnesis)&#xD;
&#xD;
          -  Taking allopathic medication: digitalis, beta blockers, antiarrhythmics&#xD;
&#xD;
          -  Bronchial asthma (recorded by anamnesis)&#xD;
&#xD;
          -  Alcohol abuse&#xD;
&#xD;
          -  Heart diseases NYHA class IV&#xD;
&#xD;
          -  Blood pressure side difference ≥ 10mmHg&#xD;
&#xD;
          -  Fever (&gt; 37,5°C)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Vagedes, MD</last_name>
    <role>Study Director</role>
    <affiliation>ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ARCIM Institute</name>
      <address>
        <city>Filderstadt</city>
        <state>Baden Württemberg</state>
        <zip>70794</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>August 6, 2019</last_update_submitted>
  <last_update_submitted_qc>August 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiovascular parameters</keyword>
  <keyword>Blood Pressure</keyword>
  <keyword>Pulse Wave</keyword>
  <keyword>Ergometry</keyword>
  <keyword>Somnotouch</keyword>
  <keyword>BOSO-TM-2430</keyword>
  <!-- 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/NCT03792893
org study id: ERG_03
nct id: NCT03792893
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The objective of this randomized, controlled single blind study is to compare pulse wave and
      blood pressure measurements before, during and after exercise ergometry in healthy female
      subjects.
In a randomized single-blind study design the investigators explore how well blood pressure
      parameters calculated using a Pulse Transit Time-based method (device: SOMNOtouchTM RESP)
      match blood pressure parameters measured by a classic upper arm blood pressure cuff
      (BOSO-TM-2430 ) under standardized load conditions (ergometry).

      In 30 healthy female subjects (age 18 - 40 years), cardiovascular parameters before, during
      and after a standardized load on a bicycle ergometer (half-lying position) are recorded with
      three different devices (BOSO-TM-2430 versus SOMNOtouchTM RESP versus GeTeMed Vitaguard 3100)
      and compared.

      Primary outcome is the difference of the systolic blood pressure values between the devices
      BOSO-TM-2430 versus SOMNOtouchTM RESP during the three phases.

      The BOSO-TM-2430 blood pressure cuff is applied randomized to the arm with the previously
      determined higher or lower systolic blood pressure mean difference. The subjects are blinded
      to the results of the measurements during ergometry.

      After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer
      for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase
      every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest period.
      Measurements are taken every two minutes with the BOSO-TM-2430; data acquisition with the
      SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 devices takes place continuously over a total
      duration of 72 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Difference of the systolic blood pressure
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Primary outcome is the difference of the systolic blood pressure values between the devices BOSO-TM-2430 versus SOMNOtouchTM RESP during the three phases
measure: Diastolic Blood Pressure (SOMNOtouchTM RESP)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Diastolic Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
measure: Mean Arterial Blood Pressure (SOMNOtouchTM RESP)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Mean Arterial Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
measure: Pulse Pressure (SOMNOtouchTM RESP)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Pulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
measure: Heartrate (SOMNOtouchTM RESP)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Heartrate (beats per minute, bpm) measured with the SOMNOtouchTM RESP device
measure: Oxygen saturation (SpO2, SOMNOtouchTM RESP)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Oxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device
measure: Pulse-Transit-Time (PTT, SOMNOtouchTM RESP)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device
measure: Systolic Blood Pressure measured with the device BOSO-TM-2430
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Systolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device
measure: Diastolic Blood Pressure measured with the device BOSO-TM-2430
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Diastolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device
measure: Mean Arterial Blood Pressure measured with the device BOSO-TM-2430
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Mean Arterial Blood Pressure (mmHg) measured with the BOSO-TM-2430 device
measure: Pulse Pressure measured with the device BOSO-TM-2430
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Pulse Pressure (mmHg) measured with the BOSO-TM-2430 device
measure: Heartrate measured with the device BOSO-TM-2430
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Heartrate (beats per minute, bpm) measured with the BOSO-TM-2430 device
measure: Pulse Transit Time (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Pulse Transit Time (PTT, ms) measured with the GeTeMed Vitaguard 3100 device
measure: Perfusion Index (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Perfusion Index (PI) measured with the GeTeMed Vitaguard 3100 device
measure: Peak to Peak Time (PPT) (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100 device
measure: SlopeInW1 (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: SlopeInW1 measured with the GeTeMed Vitaguard 3100 device
measure: SlopeInW2 (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: SlopeInW2 measured with the GeTeMed Vitaguard 3100 device
measure: SlopeInW3 (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: SlopeInW3 measured with the GeTeMed Vitaguard 3100 device
measure: SlopeInW4 (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: SlopeInW4 measured with the GeTeMed Vitaguard 3100 device
measure: StiffnessIndex (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: StiffnessIndex measured with the GeTeMed Vitaguard 3100 device
measure: ReflectionIndex (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: ReflectionIndex measured with the GeTeMed Vitaguard 3100 device
measure: TimeTX (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: TimeTX (ms) measured with the GeTeMed Vitaguard 3100 device
measure: TimeTY (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: TimeTY (ms) measured with the GeTeMed Vitaguard 3100 device
measure: QuotTYTX (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: QuotTYTX measured with the GeTeMed Vitaguard 3100 device
measure: AreaAX (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: AreaAX measured with the GeTeMed Vitaguard 3100 device
measure: AreaAY (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: AreaAY measured with the GeTeMed Vitaguard 3100 device
measure: QuotAYAX (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: QuotAYAX measured with the GeTeMed Vitaguard 3100 device
measure: AreaAV (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: AreaAV measured with the GeTeMed Vitaguard 3100 device
measure: AreaAW (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: AreaAW measured with the GeTeMed Vitaguard 3100 device
measure: QuotAWAV (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: QuotAWAV measured with the GeTeMed Vitaguard 3100 device
measure: QuotTVTW (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: QuotTVTW measured with the GeTeMed Vitaguard 3100 device
measure: TimeTV (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: TimeTV (ms) measured with the GeTeMed Vitaguard 3100 device
measure: TimeTW (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: TimeTW (ms) measured with the GeTeMed Vitaguard 3100 device
measure: MinT1 (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the first peak
measure: MinT2 (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak
measure: MaxT1 (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the first peak
measure: MaxT2 (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the second peak
measure: QuotHRRespRate (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
description: Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device
arm group label: Higher Blood Pressure
arm group type: Experimental
description: BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure. Intervention: Ergometry H
arm group label: Lower Blood Pressure
arm group type: Experimental
description: BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure. Intervention: Ergometry L
intervention type: Other
intervention name: Ergometry H
description: After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest periodmaximum load of 180 watts), followed by a 15-minute post-rest period.
BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure (reference parameter).
SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined lower systolic blood pressure.
arm group label: Higher Blood Pressure
intervention type: Other
intervention name: Ergometry L
description: After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest periodmaximum load of 180 watts), followed by a 15-minute post-rest period.
BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure (reference parameter).
SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined higher systolic blood pressure.
arm group label: Lower Blood Pressure
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Vagedes, MD
role: Study Director
affiliation: ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany
facility: 
country: Germany
responsible party type: Sponsor