<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/NCT03790722</url>
  </required_header>
  <id_info>
    <org_study_id>ERG_02</org_study_id>
    <nct_id>NCT03790722</nct_id>
  </id_info>
  <brief_title>Comparison of Pulse Wave and Blood Pressure Measurements Before, During and After Ergometry in Healthy Men</brief_title>
  <official_title>Comparison of Pulse Wave and Blood Pressure Parameters Before, During and After Exercise Ergometry in Healthy Male 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 male&#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;
      (Mobil-O-Graph® PWA) under standardized load conditions (ergometry).&#xD;
&#xD;
      In 30 healthy male subjects (age 18 - 40 years), cardiovascular parameters before, during and&#xD;
      after a standardized load on a bicycle ergometer (half-lying position) are recorded with&#xD;
      three different devices (Mobil-O-Graph® PWA versus SOMNOtouchTM RESP versus GeTeMed Vitaguard&#xD;
      3100) and compared.&#xD;
&#xD;
      Primary outcome is the difference of the systolic blood pressure values between the devices&#xD;
      Mobil-O-Graph® PWA versus SOMNOtouchTM RESP during the three phases.&#xD;
&#xD;
      The Mobil-O-Graph® PWA blood pressure cuff is applied randomized to the arm with the&#xD;
      previously determined higher or lower systolic blood pressure mean difference. The subjects&#xD;
      are blinded 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 Mobil-O-Graph® PWA; data acquisition with&#xD;
      the SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 devices takes place continuously over a&#xD;
      total duration of 72 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Actual">May 22, 2019</completion_date>
  <primary_completion_date type="Actual">May 22, 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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Primary outcome is the difference of the systolic blood pressure values between the devices Mobil-O-Graph® PWA 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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 Mobil-O-Graph® PWA</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Systolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure measured with the device Mobil-O-Graph® PWA</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Diastolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Arterial Blood Pressure measured with the device Mobil-O-Graph® PWA</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Mean Arterial Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse Pressure measured with the device Mobil-O-Graph® PWA</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Pulse Pressure (mmHg) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heartrate (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Heartrate (beats per minute, bpm) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Puls Pressure Amplification (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Puls Pressure Amplification measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Volume (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Stroke Volume (ml) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac output (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Cardiac output (l/min) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular Resistance (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Vascular Resistance (s*mmHg/ml) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Index (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Cardiac Index (l/min*1/m2) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Augmentation Pressure (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Augmentation Pressure (mmHg) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reflection Coefficient (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Reflection Coefficient (%) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse Wave Velocity (PWV) (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Pulse Wave Velocity (PWV, m/s) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systole Time (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Systole Time (s) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax-forward (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Tmax-forward (s) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax-backward (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Tmax-backward (s) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forward Pressure (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Forward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Backward Pressure (Mobil-O-Graph® PWA)</measure>
    <time_frame>Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min</time_frame>
    <description>Backward Pressure (mmHg) measured with the Mobil-O-Graph® PWA 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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 min (Mobil-O-Graph©PWA) for a total duration of 72 min</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 Male Subjects</condition>
  <arm_group>
    <arm_group_label>Higher Blood Pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mobil-O-Graph PWA 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>Mobil-O-Graph PWA 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;
Mobil-O-Graph PWA 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;
Mobil-O-Graph PWA 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>Male</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>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 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>MobiloGraph</keyword>
  <keyword>Somnotouch</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/NCT03790722
org study id: ERG_02
nct id: NCT03790722
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 male
      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
      (Mobil-O-Graph® PWA) under standardized load conditions (ergometry).

      In 30 healthy male 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 (Mobil-O-Graph® PWA versus SOMNOtouchTM RESP versus GeTeMed Vitaguard
      3100) and compared.

      Primary outcome is the difference of the systolic blood pressure values between the devices
      Mobil-O-Graph® PWA versus SOMNOtouchTM RESP during the three phases.

      The Mobil-O-Graph® PWA 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 Mobil-O-Graph® PWA; 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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Primary outcome is the difference of the systolic blood pressure values between the devices Mobil-O-Graph® PWA 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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device
measure: Systolic Blood Pressure measured with the device Mobil-O-Graph® PWA
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Systolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
measure: Diastolic Blood Pressure measured with the device Mobil-O-Graph® PWA
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Diastolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
measure: Mean Arterial Blood Pressure measured with the device Mobil-O-Graph® PWA
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Mean Arterial Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
measure: Pulse Pressure measured with the device Mobil-O-Graph® PWA
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Pulse Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
measure: Heartrate (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Heartrate (beats per minute, bpm) measured with the Mobil-O-Graph® PWA device
measure: Puls Pressure Amplification (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Puls Pressure Amplification measured with the Mobil-O-Graph® PWA device
measure: Stroke Volume (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Stroke Volume (ml) measured with the Mobil-O-Graph® PWA device
measure: Cardiac output (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Cardiac output (l/min) measured with the Mobil-O-Graph® PWA device
measure: Vascular Resistance (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Vascular Resistance (s*mmHg/ml) measured with the Mobil-O-Graph® PWA device
measure: Cardiac Index (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Cardiac Index (l/min*1/m2) measured with the Mobil-O-Graph® PWA device
measure: Augmentation Pressure (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Augmentation Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
measure: Reflection Coefficient (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Reflection Coefficient (%) measured with the Mobil-O-Graph® PWA device
measure: Pulse Wave Velocity (PWV) (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Pulse Wave Velocity (PWV, m/s) measured with the Mobil-O-Graph® PWA device
measure: Systole Time (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Systole Time (s) measured with the Mobil-O-Graph® PWA device
measure: Tmax-forward (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Tmax-forward (s) measured with the Mobil-O-Graph® PWA device
measure: Tmax-backward (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Tmax-backward (s) measured with the Mobil-O-Graph® PWA device
measure: Forward Pressure (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Forward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
measure: Backward Pressure (Mobil-O-Graph® PWA)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
description: Backward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
measure: Pulse Transit Time (GeTeMed Vitaguard 3100)
time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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 min (Mobil-O-Graph©PWA) for a total duration of 72 min
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: Mobil-O-Graph PWA 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: Mobil-O-Graph PWA 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.
Mobil-O-Graph PWA 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.
Mobil-O-Graph PWA 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: Male
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