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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02382926
Other study ID # CTC-A 14-053
Secondary ID
Status Completed
Phase N/A
First received March 3, 2015
Last updated March 12, 2015
Start date October 2014
Est. completion date November 2014

Study information

Verified date March 2015
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

In this trial contactless heart rate, electrocardiography and breathing rate measurements are elevated during car simulation in cardiac rehabilitation via automotive sensors and camera.


Description:

Increasing number of elderly people with cardiovascular diseases and the wish to drive a car need recommendations corresponding to their fitness of driving during cardiac rehabilitation. Little trial data are known, only a position paper of the German Cardiac Society (DGK) of 2010 discusses the aptitude of driving a car of cardiovascular patients on experience. For judgement and recommendations automotive monitoring via contactless sensors might be helpful. Therefore while "driving" in a simulator distinct heart circulation situations will be created. Vital signs will be measured via long term electrocardiography (ECG) in comparison to contactless capacitive ECG (cECG) measurements via embedded sensors in the car seat as well as heart rate and breathing rate measurements via camera.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- cardiologic diseases after acute event (e. g. myocard infarction, bypass surgery)

- rehabilitation in clinic "An der Rosenquelle"

Exclusion Criteria:

- dementia

- lack of language ability

- pregnancy

- implanted electric devices (as e.g. heart pacemaker, inverted cardiodefibrillator)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Capacitive ECG and contactless heart and breathing rate measurements via camera
During a 30 minute driving simulation cardiologic patients in rehabilitation undergo capacitive ECG measurements via sensors in the car seat as well as heart and breathing rate measurements via camera according to the Eulerian Magnification Method.

Locations

Country Name City State
Germany Clinic of Rehabilitation "An der Rosenquelle", Kurbrunnenstreet 5 Aachen North Rhine Westphalia
Germany University Hospital Aachen, Department of Cardiology, Angiology, Pneumology and Intensive Medicine Aachen North Rhine Westphalia

Sponsors (2)

Lead Sponsor Collaborator
RWTH Aachen University RWTH Aachen Institute of Medical Information Technology

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Breathing rate via contactless camera feasibility of breathing rate measurements according to the Eulerian Magnification Method in comparison to standard measurement data 30 minutes Yes
Primary arrhythmia feasibility of cECG data for example as arrhythmia, tachycardia in comparison to long term ECG data 30 minutes Yes
Secondary Heart rate via contactless camera feasibility of heart rate measurements according to the Eulerian Magnification Method in comparison to standard measurement data 30 minutes Yes
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