HealthyNCT01708577
UMIC Validation Study
A study testing Validation of the IPANEMA - measurement system in people with Healthy, run by RWTH Aachen University at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Validation of the IPANEMA - measurement system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy, sporty person
- age 18-35 years
- able to give informed consent
Who cannot join
- electrophobics
- metallic and / or electric implants
- balance difficulties
- cardiac insufficiency
- arterial hypotension
- truncal ataxia
- underage persons
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Internal Medicine I, University Hospital
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Ultra High Speed Mobile Information and Communication
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Validation of the IPANEMA - measurement system
- Keywords
- heart rate, sweating, respiration, acceleration of body movement, heart activity.
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of the IPANEMA - measurement systemDevice
Control of the body conditions under real life conditions during a sportive activity.
| Study group | Role | What they receive |
|---|---|---|
| IPANEMA validation without water intake | Experimental | 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. Receives: Device: Validation of the IPANEMA - measurement system |
| IPANEMA validation with water intake | Experimental | The one group is restricted to the water intake during the Indoor phase, the other group is not restricted to the water intake. Receives: Device: Validation of the IPANEMA - measurement system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of vital signs out of a portable measuring system for monitoring performance of athletes during exercise
Validation of a new portable und functional sensor based monitoring system.
Measured: ten measurements each three hours
Secondary outcomes (1)
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
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
Measured: ten measurements each three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startJul 2011
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Krüger, Univ.-Prof., Principal investigator, Internal Medicine I, University Hospital Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708577
- Sponsor's protocol ID
- 11-111
- Other IDs
- EK 180/11
- Status last verified
- Nov 2012
- First submitted
- 28 Sep 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra High Speed Mobile Information and Communication
- ClinicalTrials.gov ID
- NCT01708577
- Acronym / sponsor ID
- 11-111
- Conditions
- Healthy
- Keywords
- heart rate, sweating, respiration, acceleration of body movement, heart activity.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPANEMA validation without water intake | Experimental | Device: Validation of the IPANEMA - measurement systemThe 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. |
| IPANEMA validation with water intake | Experimental | Device: Validation of the IPANEMA - measurement systemThe one group is restricted to the water intake during the Indoor phase, the other group is not restricted to the water intake. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy, sporty person
- age 18-35 years
- able to give informed consent
Key exclusion criteria (8 listed)
- electrophobics
- metallic and / or electric implants
- balance difficulties
- cardiac insufficiency
- arterial hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation of the IPANEMA - measurement systemControl of the body conditions under real life conditions during a sportive activity. | Device | IPANEMA validation with water intake, IPANEMA validation without water intake |
Primary outcome
Determination of vital signs out of a portable measuring system for monitoring performance of athletes during exercise
Time frame: ten measurements each three hours
Validation of a new portable und functional sensor based monitoring system.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Krüger, Univ.-Prof. principal investigator
Internal Medicine I, University Hospital Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Validation of the IPANEMA - measurement system in people with Healthy, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.