Trial document




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  DRKS00007976

Trial Description

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Title

Measurement of heart rate variability - comparison of two systems in probands and a technical model

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Heart rate variability (HRV) is understood as the ability of an organism to alter the frequency of the heart rhythm. The measurement of this parameter ot the autonomic nervous system has been generally used for some time to evaluate the condition of a patient and has significance in different fields. In the field of medicine for example it is known that there are correlations concerning the risk evaluation after myocardial infarction or concerning the development of a neuropathy (nerve impairment) when suffering from diabetes mellitus. In addition there arise new areas of application, for instance in psychosomatic medicine (depression and heart rate variability), environmental medicine (pollution and heart rate variability) or sports medicine and sports science. After all one can find devices for the measurement of heart rate variability in connection with stress prevention or biofeedback. Detection of heart rate variability is thus used both in a medical context and in the fields of sports and lifestyle sciences.
Heart rate variability can be detected directly from the ECG recording or indirectly via pulse curve, which can be registered at the earlobe or the fingertip for instance. In this study the detection of heart rate variability and its alteration after simulation of stress are to be compared in probands and by the use of a technical model with two different systems: 1. a professional system for heart rate variability studies ("HRV-Scanner Study", BioSign systems) and 2. a free stress-app of the apple app-store ("stress check", Azumio Inc. used on an Apple iPhone 4S).
The interesting part is if and to what extend the free app is able to detect the simulated stress situation. For this purpose there are measurements planned both in probands and with a technical model, which is able to simulate extreme situations, to rule out that the app uses only the rate of the heart frequency for its evalutation. The data collection in the probands is parallel via pulse wave detection clip on the ear and camera of the iPhone on the fingertip first lying down after resting for 10 minutes and after induction of stress (10 knee bends and standing afterwards) requiring each about 5 minutes.

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Brief Summary in Scientific Language

Heart rate variability (HRV) is understood as the ability of an organism to alter the frequency of the heart rhythm. The measurement of this parameter ot the autonomic nervous system has been generally used for some time to evaluate the condition of a patient and has significance in different fields. In the field of medicine for example it is known that there are correlations concerning the risk evaluation after myocardial infarction or concerning the development of a neuropathy when suffering from diabetes mellitus (5;6). In addition there arise new areas of application, for instance in psychosomatic medicine (depression and heart rate variability, (3;4)), environmental medicine (pollution and heart rate variability, (2)) or sports medicine and sports science (1). After all one can find devices for the measurement of heart rate variability in connection with stress prevention or biofeedback (4). Detection of heart rate variability is thus used both in a medical context and in the fields of sports and lifestyle sciences.
Heart rate variability can be detected directly from the ECG recording or indirectly via pulse curve, which can be registered non-invasively at the earlobe or the fingertip for instance. In this study the detection of heart rate variability and its alteration after simulation of stress are to be compared in probands and by the use of a technical model with two different systems: 1. a professional system for heart rate variability studies ("HRV-Scanner Study", BioSign systems) and 2. a free stress-app of the apple app-store ("stress check", Azumio Inc. used on an Apple iPhone 4S).
The interesting part is if and to what extend the free app is able to detect the simulated stress situation. For this purpose there are measurements planned both in probands and with a technical model, which is able to simulate extreme situations, to rule out that the app uses only the rate of the heart frequency for its evalutation. The data collection in the probands is parallel via pulse wave detection clip on the ear and camera of the iPhone on the fingertip first lying down after resting for 10 minutes and after induction of stress (10 knee bends and standing afterwards) requiring each about 5 minutes.

Literature:
(1) Hottenrott K; Hoos O; Esperer HD (2006): Herzfrequenzvariabilität und Sport. Herz 31 (6), S. 544–552.
(2) Magari SR; Hauser R; Schwartz J; Williams PL; Smith TJ; Christiani DC (2001): Association of Heart Rate Variability With Occupational and Environmental Exposure to Particulate Air Pollution. Circulation 104 (9), S. 986–991.
(3) Mück-Weymann M; Mösler T; Joraschky P; Rebensburg M; Agelink MW (2002): Depression modulates autonomic cardiac control: a physiological pathway linking depression and mortality? German Journal of Psychiatry (5), S. 67–69.
(4) Siepmann M; Aykac V; Unterdörfer J; Petrowski K; Mueck-Weymann M (2008): A pilot study on the effects of heart rate variability biofeedback in patients with depression and in healthy subjects. Applied psychophysiology and biofeedback 33 (4), S. 195–201.
(5) Task Force of the European Society of Cardiology the North American Society of Pacing Electrophysiology (1996): Heart Rate Variability. Standards of Measurement, Physiological Interpretation, and Clinical Use. Circulation 93 (5), S. 1043–1065.
(6) van Ravenswaaij-Arts, Conny M. A. (1993): Heart Rate Variability. Ann Intern Med 118 (6), S. 436.

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Organizational Data

  •   DRKS00007976
  •   2015/04/13
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  •   yes
  •   Approved
  •   2015-523N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   heart rate variability
  •   healthy volunteers
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Interventions/Observational Groups

  •   Measurement of heart rate variability / stress level with an iPhone app non-invasively (detection of the pulse wave via iPhone camera on the fingertip) in the complete cohort of probands first at rest after a resting period of 10 minutes and subsequently after induction of stress (10 knee bends with following standing), measurement for 5 minutes each time
  •   Measurement of heart rate variability / stress level with a professional heart rate variability study system non-invasively (detection of the pulse wave via clip on the earlobe) in the complete cohort of probands first at rest after a resting period of 10 minutes and subsequently after induction of stress (10 knee bends with following standing), measurement for 5 minutes each time
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Differences in the alteration of heart rate variability after intervention; measurement directly after intervention; measurement with both systems

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Secondary Outcome

Comparison of the results received from the probands wirh the results received from the technical model; after completion of all measurements; results from both systems with both probands and technical model

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/04/30
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

healthy probands of full age that are capable of granting their consent

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Exclusion Criteria

- pregnancy
- regular taking of medication affecting the heart or circulation system or the autonomic nervous system (blood pressure and heart rate medication, psychiatric or neurological medication)

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Addresses

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    • Universitätsmedizin Mannheim, Klinik für Anästhesiologie und operative Intensivmedizin
    • Mr.  Dr. med.  Frieder  Keck 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsmedizin Mannheim, Klinik für Anästhesiologie und operative Intensivmedizin
    • Mr.  Dr. med.  Frieder  Keck 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsmedizin Mannheim, Klinik für Anästhesiologie und operative Intensivmedizin
    • Mr.  Dr. med.  Frieder  Keck 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Mannheim, Klinik für Anästhesiologie und operative Intensivmedizin
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/02/06
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.