An interventional study of Vagal Nerve Stimulation and Sham stimulation in Healthy Adult Participants, sponsored by Daniel Keszthelyi. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Daniel Keszthelyi · Not applicable, Interventional, and Other
This single-center randomized controlled trial aims to investigate the effects of transcutaneous auricular vagus nerve stimulation on the acute stress responses.
The primary aim of this study is to assess the efficacy of taVNS in mitigating the acute stress response induced by the Maastricht Acute Stress Task (MAST) among healthy subjects, measured by cortisol levels in saliva samples.
Secondary objectives include:
Participants will be randomly assigned to either the taVNS or sham stimulation group, administered 30 minutes before the MAST.
Daniel Keszthelyi is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Transcutaneous auricular vagal nerve stimulation, for 30 minutes
Device: Vagal Nerve Stimulation
Sham stimulation with a non-conducting electrode, for 30 minutes
Device: Sham stimulation
Transcutaneous Auricular Vagal Nerve Stimulation
Sham stimulation with a non-conducting electrode
Neuroendocrine stress response
A significant reduction in the neuroendocrine stress response triggered by the MAST following taVNS or sham treatment, assessed through saliva cortisol samples, with a defined threshold of a 35% decrease.
Time frame: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Subjective stress response
Subjective stress responses to the MAST following taVNS or sham treatment, assessed using the negative affect subscale of the International Positive and Negative Affect Schedule Short Form (I-PANAS-SF; total score range: 5-25, with higher scores indicating greater negative affect) and 0-100 Visual Analog Scales (VAS) for stress, pain, and unpleasantness (0=not at all, 100=extremely; higher scores indicate greater perceived stress, pain, or unpleasantness).
Time frame: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Cardiovascular stress response - blood pressure
Changes in systolic and diastolic blood pressure responses to the Maastricht Acute Stress Test (MAST) following transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation, assessed in mmHg. Blood pressure was measured four times.
Time frame: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Autonomic stress response: heart rate variability
Changes in heart rate variability responses to the Maastricht Acute Stress Test (MAST) following transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation, assessed using Fitbit and Shimmer3 GSR. Heart rate variability was measured continuously during the test day.
Time frame: Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Electrodermal stress response: skin conductance
Changes in skin conductance responses to the Maastricht Acute Stress Test (MAST) following transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation, assessed in microsiemens (µS).
Time frame: Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Anxiety symptoms
Anxiety symptoms assessed using the Generalized Anxiety Disorder-7 questionnaire (GAD-7; total score range: 0-21, with higher scores indicating greater anxiety symptom severity).
Time frame: Assessed once during the screening visit, prior to the experimental test day
Depressive symptoms
Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9; total score range: 0-27, with higher scores indicating greater depressive symptom severity).
Time frame: Assessed once during the screening visit, prior to the experimental test day
Personality traits
Personality traits assessed using the Big Five Inventory-44 (BFI-44). The BFI-44 measures five personality domains (Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Openness to Experience). Each domain score is computed as a sum or mean of item responses on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), with higher scores indicating greater expression of the respective personality trait.
Time frame: Assessed once during the screening visit, prior to the experimental test day
Adverse events
Number and severity of adverse events
Time frame: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
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Plan to share: No
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Daniel Keszthelyi