<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/NCT01708577</url>
  </required_header>
  <id_info>
    <org_study_id>11-111</org_study_id>
    <secondary_id>EK 180/11</secondary_id>
    <nct_id>NCT01708577</nct_id>
  </id_info>
  <brief_title>UMIC Validation Study</brief_title>
  <official_title>Ultra High Speed Mobile Information and Communication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RWTH Aachen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RWTH Aachen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the feasibility of a new wearable computerised system&#xD;
      designed for an ongoing monitoring of sportsmen under real-life conditions. This system&#xD;
      consists of different sensors and Bluetooth Transmitters interconnected by wires and&#xD;
      integrated in the textile of a T-shirt. Several physiologic parameters including bioimpedance&#xD;
      should be investigated under conditions relevant for an intensive physical activity, like&#xD;
      high body temperature or partial dehydration. This system has to be tested under laboratory&#xD;
      and &quot;natural/open air&quot; conditions, the obtained evaluations compared with standardised&#xD;
      established diagnostic methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The new wearable sensor- and monitoring system has to be tested on 20 healthy sportsmen of&#xD;
      both genders in the age between 18 and 35 years. The aim of the present study is the&#xD;
      characterisation of technical parameters, diagnostic precision and practical applicability of&#xD;
      this system, which should be able to measure and translate information of actual physiologic&#xD;
      state during the physical activity of sportsmen under real-life conditions.&#xD;
&#xD;
      IPANEMA (Integrated Posture and Activity Network) is a construct consisting of electrodes and&#xD;
      several specialized sensors integrated in the textile tissue of a T-Shirt and interconnected&#xD;
      with &quot;electronic nods&quot;, an equipment supporting the central computerized control system with&#xD;
      information via Bluetooth signals.&#xD;
&#xD;
      This body sensor network enables ablations of electrical activity of heart (ECG),&#xD;
      Bioimpedance Spectroscopy (BIS), measuring of temperature and humidity on the surface of&#xD;
      skin, breathing intensity and acceleration of body movement.&#xD;
&#xD;
      The study is divided in 3 parts, the indoor part, the outdoor part, and the part of&#xD;
      measurements under controlled artificial temperature conditions (climate chamber).&#xD;
&#xD;
      The outdoor measurements will be performed at different running tracks, e.g. at the&#xD;
      Hochschulsportzentrum, Lousberg, and can be separated in two subtypes, the training and the&#xD;
      competition.&#xD;
&#xD;
      The indoor study phase lasts ca. 2 hours, where the volunteers will be analysed during&#xD;
      running on a tread mill with both, the IPANEMA system and common medical monitoring&#xD;
      procedures. The evaluations of identical physiological parameters obtained by use of&#xD;
      stationary diagnostic equipment, the ergospirometric device PowerCube Ergo, BIS measurement&#xD;
      system Xitron Hydra 4200, infra-red camera VarioCam®hr-basic and standard medical ECG&#xD;
      measurements are used as reference values. Two hours before the start and during the entire&#xD;
      training phase, the experimental group is restricted to food and liquid intake in opposite to&#xD;
      control group. These experimental conditions purpose to clarify several physiological effects&#xD;
      of dehydration during sportive activities. The outdoor- and climate chamber- investigations&#xD;
      do not prescribe the liquid deprivation.&#xD;
&#xD;
      The climate chamber measurements will be performed in a temperature controlled room. This&#xD;
      measurement session can last up to 3 hours and temperature inside of climate chamber can be&#xD;
      increased until 40Cº. Such conditions may simulate body sensor network and elicit&#xD;
      physiological effects comparable to effects obtained during sportive activities. No sport is&#xD;
      performed by volunteers during the climate chamber phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determination of vital signs out of a portable measuring system for monitoring performance of athletes during exercise</measure>
    <time_frame>ten measurements each three hours</time_frame>
    <description>Validation of a new portable und functional sensor based monitoring system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determination of vital signs out of a new textile integrated and portable measurement system during training and competition conditions in comparision to parallel measurements with the reference devices</measure>
    <time_frame>ten measurements each three hours</time_frame>
    <description>Due to the design and type of measurements the study is divided into 3 parts, Indoor, Outdoor and Climate Chamber. The measurement duration for every part lasts 2-3 hours. The obtained data will be compared to results obtained by conventional methods. It includes the precision of measurement, the transfer of data and validation of computer supported data analysis. The measured parameters include temperature of the body, humidity on the body surface, ECG, volume and rate of breathing</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>IPANEMA validation without water intake</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The one group is restricted to the water intake during the Indoor phase during testing the IPANEMA measurement system. The other group is not restricted to the water intake.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPANEMA validation with water intake</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The one group is restricted to the water intake during the Indoor phase, the other group is not restricted to the water intake.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Validation of the IPANEMA - measurement system</intervention_name>
    <description>Control of the body conditions under real life conditions during a sportive activity.</description>
    <arm_group_label>IPANEMA validation with water intake</arm_group_label>
    <arm_group_label>IPANEMA validation without water intake</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy, sporty person&#xD;
&#xD;
          -  age 18-35 years&#xD;
&#xD;
          -  able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  electrophobics&#xD;
&#xD;
          -  metallic and / or electric implants&#xD;
&#xD;
          -  balance difficulties&#xD;
&#xD;
          -  cardiac insufficiency&#xD;
&#xD;
          -  arterial hypotension&#xD;
&#xD;
          -  truncal ataxia&#xD;
&#xD;
          -  underage persons&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Krüger, Univ.-Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Internal Medicine I, University Hospital Aachen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Internal Medicine I, University Hospital</name>
      <address>
        <city>Aachen</city>
        <state>North Rhine-Westphalia</state>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>November 13, 2012</last_update_submitted>
  <last_update_submitted_qc>November 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart rate</keyword>
  <keyword>sweating</keyword>
  <keyword>respiration</keyword>
  <keyword>acceleration of body movement</keyword>
  <keyword>heart activity.</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/NCT01708577
org study id: 11-111
secondary id: EK 180/11
nct id: NCT01708577
lead sponsor: 
has dmc: No
The purpose of the study is to evaluate the feasibility of a new wearable computerised system
      designed for an ongoing monitoring of sportsmen under real-life conditions. This system
      consists of different sensors and Bluetooth Transmitters interconnected by wires and
      integrated in the textile of a T-shirt. Several physiologic parameters including bioimpedance
      should be investigated under conditions relevant for an intensive physical activity, like
      high body temperature or partial dehydration. This system has to be tested under laboratory
      and "natural/open air" conditions, the obtained evaluations compared with standardised
      established diagnostic methods.
The new wearable sensor- and monitoring system has to be tested on 20 healthy sportsmen of
      both genders in the age between 18 and 35 years. The aim of the present study is the
      characterisation of technical parameters, diagnostic precision and practical applicability of
      this system, which should be able to measure and translate information of actual physiologic
      state during the physical activity of sportsmen under real-life conditions.

      IPANEMA (Integrated Posture and Activity Network) is a construct consisting of electrodes and
      several specialized sensors integrated in the textile tissue of a T-Shirt and interconnected
      with "electronic nods", an equipment supporting the central computerized control system with
      information via Bluetooth signals.

      This body sensor network enables ablations of electrical activity of heart (ECG),
      Bioimpedance Spectroscopy (BIS), measuring of temperature and humidity on the surface of
      skin, breathing intensity and acceleration of body movement.

      The study is divided in 3 parts, the indoor part, the outdoor part, and the part of
      measurements under controlled artificial temperature conditions (climate chamber).

      The outdoor measurements will be performed at different running tracks, e.g. at the
      Hochschulsportzentrum, Lousberg, and can be separated in two subtypes, the training and the
      competition.

      The indoor study phase lasts ca. 2 hours, where the volunteers will be analysed during
      running on a tread mill with both, the IPANEMA system and common medical monitoring
      procedures. The evaluations of identical physiological parameters obtained by use of
      stationary diagnostic equipment, the ergospirometric device PowerCube Ergo, BIS measurement
      system Xitron Hydra 4200, infra-red camera VarioCam®hr-basic and standard medical ECG
      measurements are used as reference values. Two hours before the start and during the entire
      training phase, the experimental group is restricted to food and liquid intake in opposite to
      control group. These experimental conditions purpose to clarify several physiological effects
      of dehydration during sportive activities. The outdoor- and climate chamber- investigations
      do not prescribe the liquid deprivation.

      The climate chamber measurements will be performed in a temperature controlled room. This
      measurement session can last up to 3 hours and temperature inside of climate chamber can be
      increased until 40Cº. Such conditions may simulate body sensor network and elicit
      physiological effects comparable to effects obtained during sportive activities. No sport is
      performed by volunteers during the climate chamber phase.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Determination of vital signs out of a portable measuring system for monitoring performance of athletes during exercise
time frame: ten measurements each three hours
description: Validation of a new portable und functional sensor based monitoring system.
measure: Determination of vital signs out of a new textile integrated and portable measurement system during training and competition conditions in comparision to parallel measurements with the reference devices
time frame: ten measurements each three hours
description: Due to the design and type of measurements the study is divided into 3 parts, Indoor, Outdoor and Climate Chamber. The measurement duration for every part lasts 2-3 hours. The obtained data will be compared to results obtained by conventional methods. It includes the precision of measurement, the transfer of data and validation of computer supported data analysis. The measured parameters include temperature of the body, humidity on the body surface, ECG, volume and rate of breathing
arm group label: IPANEMA validation without water intake
arm group type: Experimental
description: The one group is restricted to the water intake during the Indoor phase during testing the IPANEMA measurement system. The other group is not restricted to the water intake.
arm group label: IPANEMA validation with water intake
arm group type: Experimental
description: The one group is restricted to the water intake during the Indoor phase, the other group is not restricted to the water intake.
intervention type: Device
intervention name: Validation of the IPANEMA - measurement system
description: Control of the body conditions under real life conditions during a sportive activity.
arm group label: IPANEMA validation with water intake
arm group label: IPANEMA validation without water intake
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stefan Krüger, Univ.-Prof.
role: Principal Investigator
affiliation: Internal Medicine I, University Hospital Aachen
facility: 
country: Germany
responsible party type: Sponsor