Trial document





This trial has been registered retrospectively.
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  DRKS00007991

Trial Description

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Title


Buffering effects of non-invasive vagus nerve stimulation on stress-induced psychobiological alterations: a placebo-controlled trial in normal-weight and obese subjects

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Trial Acronym

[---]*

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URL of the Trial

http://www.stressaware.ch

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Brief Summary in Lay Language

Stress is a major risk factor which crucially influences the development and aggravation of different physical diseases and mental disorders. In fact, stress can disrupt physiological homeostasis and induce alterations in the activity of the body. In the short term, this might be helpful and health-promoting, but in the long term or when inadequate in magnitude it can result in harm. The vagus nerv is of great importance during periods of stress and plays a regulatory role in homeostatic and stress physiology. One well-established procedure to stimulate the vagus nerv is the so-called invasive vagus nerv stimulation, i.e. the implantation of stimulatory devices connected via wires to the vagus nerv, similar to a cardiac pacemaker. The auricular electrical stimulation is as a mild alternative to effectively increase vagus nerv activity by stimulating the vagal nerve supply of the ear without the need for surgery. A further way is the non invasive vagus nerv stimulation by a cold test. The proposed study aims to examine the stress-buffering effects of vagus nerv activity manipulation induced by two forms of non-invasive stimulation: auricular electrical stimulation and cold face-induced stimulation.
Further we want to examine the role of body fat concerning well-being. In fact, body fat has several functions as it, for instance, also produces hormones. Therefore we want compare normal weight men with overweight men. In this study a total of 200 men are aimed to investigate. The BMI of 100 should lie between 18.5 und 25 and of another 100 between 28 and 40.

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Brief Summary in Scientific Language

Context an aimes of the project:

One aim of the project is the examination of the association between the vagus nerv and the effects of acute stress. This should be investigated concerning different physiological stress systems and activation levels. A further focus lies on a further risk factor: overweight. Overweight has been reported to alter the activity of the vagus nerv. Therefore, differences in the body weight offers the option to examine the interactions of different physiological systems on a further level. This offers a sophisticated view on the role of different physiological systems.

Scientific and societal context of the project:

On one hand, this cross-sectional study aims to examine two important health risk factors: Stress and overweight. On the other hand, it investigates the potential of body's own resources and provides therefore refers to opportunities for prevention.

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Organizational Data

  •   DRKS00007991
  •   2015/04/07
  •   [---]*
  •   yes
  •   Approved
  •   nicht zutreffend, Universität Zürich Philosophischen Fakultät Ethikkommission Präsident: Prof. Dr. Klaus Oberauer Psychologisches Institut Binzmühlestrasse 14/22 CH-80050 Zürich www.psychologie.uzh.ch
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E66.90 -  [generalization E66.9: Obesity, unspecified]
  •   E66.91 -  [generalization E66.9: Obesity, unspecified]
  •   stress
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Interventions/Observational Groups

  •   Two hundred participants are investigated. One hundred with a BMI between 18.5 and 25 and 100 with a BMI between 28 and 40. The groups are build as follows:

    I. Two groups undergo a non invasive, pain free auricular electrical Stimulation.
    Verum condition (Because of blinding not conducted by the investigator, but by a second team member. The second team member enters the room for conduction and the investigator leaves the room).
    The stimulation lasts for two hours.
  •   I. Two groups undergo a non invasive, pain free auricular electrical Stimulation.
    Placebo condition (The participants are only told that the stimulation is on. Because of blinding not conducted by the investigator, but by a second team member. The second team member enters the room for conduction and the investigator leaves the room).
    The (placebo) stimulation lasts for two hours.
  •   II. Two groups wear facial masks.
    Verum condition: The participants wear a cold mask (no double-blinding possible )

    The stimulation lasts for two hours.
  •   II. Two groups wear facial masks.
    Placebo condition: The participants wear a warm mask (no double-blinding possible )

    The (placebo) stimulation lasts for two hours.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Outcome: Stress reactiviy
Messung: physiological measures (hormones: cortisol, testosteron, progestoren, estradiol, inflammtion: cytokines, C-reactive protein, metabolic: Insulin, glucose, cardio vascular: heart rate, heart rate variability)
Time points: before, during and after stress tests

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Secondary Outcome

Psychological tests: Empathy, implicite motives, interoception and further questionnaires.

Further physiological measures: Waist-to-Hip, resting metabolic rate, bio impedance

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/04/14
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   38   Years
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Additional Inclusion Criteria


1. Male sex
2. Age range from 18-38 years
3. Good knowledge of the German language
4. BMI between 18.5 and 25 kg/m2 or between 28 and 40 kg/m2

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Exclusion Criteria

1. Acute and/or chronic somatic diseases
2. Mental disorders.
3. Known sensitivity of the head to cold, pressure, and draft
4. Medication intake or substance abuse in the last two months
5. Consumption of psychedelic drugs in the last four weeks
6. Excessive consumption of alcohol (more than 2 beverages p.d.)
7. Consumption of tobacco (more than 10 cigarettes p.d.)
8. Bodybuilding (more than 3 hours a week)
9. Wearing pacemakers, defibrillators, and cochlear and/or metal implants
10. Blood donation or significant blood loss (due to accident or surgery) in the last three months
11. Long-distance flight in the past two weeks
12. Shift work
13. Participation in a previous stress study or concomitant participation in other intervention studies

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität ZürichPsychologisches InstitutKlinische Psychologie und Psychotherapie
    • Mr.  Dr. phil.  Roberto  La Marca 
    • Binzmühlestrasse 14/26
    • 8050  Zürich
    • Switzerland
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    • Universität ZürichPsychologisches InstitutKlinische Psychologie und Psychotherapie
    • Mr.  M. Sc.  Niclà  Lozza 
    • Binzmühlestrasse 14/26
    • 8050  Zürich
    • Switzerland
    end of 1:1-Block address scientific-contact
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    • Universität ZürichPsychologisches InstitutKlinische Psychologie und Psychotherapie
    • Mr.  M. Sc.  Niclà  Lozza 
    • Binzmühlestrasse 14/26
    • 8050  Zürich
    • Switzerland
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Sources of Monetary or Material Support

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    • Swiss National Science Foundation (SNSF)
    • Wildhainweg 3 P.O. Box 8232
    • CH-3001  Bern
    • Switzerland
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    •   0041 31 308 22 22
    •   [---]*
    •   com at snf.ch
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/07/20
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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.