UMIC Validation Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01708577
First received: September 28, 2012
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Healthy
Device: Validation of the IPANEMA - measurement system

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Ultra High Speed Mobile Information and Communication

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Determination of vital signs out of a portable measuring system for monitoring performance of athletes during exercise [ Time Frame: ten measurements each three hours ] [ Designated as safety issue: No ]
    Validation of a new portable und functional sensor based monitoring system.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 12
Study Start Date: July 2011
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPANEMA validation without water intake
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.
Device: Validation of the IPANEMA - measurement system
Control of the body conditions under real life conditions during a sportive activity.
Experimental: IPANEMA validation with water intake
The one group is restricted to the water intake during the Indoor phase, the other group is not restricted to the water intake.
Device: Validation of the IPANEMA - measurement system
Control of the body conditions under real life conditions during a sportive activity.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy, sporty person
  • age 18-35 years
  • able to give informed consent

Exclusion Criteria:

  • electrophobics
  • metallic and / or electric implants
  • balance difficulties
  • cardiac insufficiency
  • arterial hypotension
  • truncal ataxia
  • underage persons
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708577

Locations
Germany
Internal Medicine I, University Hospital
Aachen, North Rhine-Westphalia, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Stefan Krüger, Univ.-Prof. Internal Medicine I, University Hospital Aachen
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01708577     History of Changes
Other Study ID Numbers: 11-111, EK 180/11
Study First Received: September 28, 2012
Last Updated: November 13, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
heart rate
sweating
respiration
acceleration of body movement
heart activity.

ClinicalTrials.gov processed this record on September 30, 2014