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Exploring the Effect of taVNS on the Acute Stress Responses

1 juni 2026 bijgewerkt door: Daniel Keszthelyi

Exploring the effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on the Acute Stress Responses: a Double-blind Randomized Controlled Trial

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:

  • Evaluating taVNS's potential to counteract stress-induced sympathetic activation and thereby alleviate stress-related effects, including negative affect, as measuring using the I-PANAS-SF questionnaire, and feelings of stress, pain, and unpleasantness, as measured with 0-100 Visual Analog Scales (VAS)
  • Assessing its impact on autonomic outflow parameters, using a blood pressure monitor for blood pressure, and a FitBit smartwatch for heart rate variability, and Shimmer3 GSR sensor for heart rate variability and skin conductance.
  • Evaluating the relationship between stress responses and affective symptoms and personality traits, utilizing the Generalized Anxiety Disorder 7-Item Scale (GAD-7), Patient Health Questionnaire (PHQ-9), and the Big Five Inventory (BFI).

Participants will be randomly assigned to either the taVNS or sham stimulation group, administered 30 minutes before the MAST.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Nederland
    • Limburg
      • Maastricht, Limburg, Nederland, 6229ER
        • Maastricht University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • Healthy participants (defined as those without a pre-existing medical comorbidity)
  • Aged between 18-65 years
  • Ability to understand and speak the Dutch language.

Exclusion Criteria:

  • Medical history or condition affecting the cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, haematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric systems, as well as prior major surgeries or ongoing laboratory abnormalities that could potentially limit participation or completion of the study protocol;
  • Any use of medication, especially those that may influence the autonomic nervous system or the hypothalamus-pituitary-adrenal axis (e.g., beta-agonists or corticosteroids), with the exception of contraceptives and paracetamol;
  • Current or lifetime psychopathology (including PHQ-9 and GHD-7 scores > 10);
  • Substance abuse (including excessive alcohol consumption);
  • Smoking;
  • Pregnancy, lactation, or intention to become pregnant during the study period;
  • Use of devices (e.g., cochlear implants) or other reasons (e.g. wounds, permanent ear-piercing) which complicate the use of the tVNS device;
  • Participation in another clinical study in which the MAST was used;
  • Administration of investigational drugs or participation in any scientific intervention study that might interfere with this study (to be determined by the principal investigator) within 180 days preceding the commencement of the study;
  • Students and employees of Maastricht University are not precluded from participation, unless they have a direct personal, professional or hierarchical position with regards to any of the study team members or their department.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Transcutaneous Auricular Vagal Nerve Stimulation
Transcutaneous auricular vagal nerve stimulation, for 30 minutes
Apparaat: Stimulatie van de vagale zenuw
Transcutane auriculaire vagale zenuwstimulatie
Placebo-vergelijker: Sham stimulation
Sham stimulation with a non-conducting electrode, for 30 minutes
Apparaat: Sham stimulation
Sham stimulation with a non-conducting electrode

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Neuroendocrine stress response
Tijdsspanne: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
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.
Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Subjective stress response
Tijdsspanne: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
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).
Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Cardiovascular stress response - blood pressure
Tijdsspanne: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
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.
Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Autonomic stress response: heart rate variability
Tijdsspanne: Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
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.
Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Electrodermal stress response: skin conductance
Tijdsspanne: Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
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).
Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Anxiety symptoms
Tijdsspanne: Assessed once during the screening visit, prior to the experimental test day
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).
Assessed once during the screening visit, prior to the experimental test day
Depressive symptoms
Tijdsspanne: Assessed once during the screening visit, prior to the experimental test day
Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9; total score range: 0-27, with higher scores indicating greater depressive symptom severity).
Assessed once during the screening visit, prior to the experimental test day
Personality traits
Tijdsspanne: Assessed once during the screening visit, prior to the experimental test day
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.
Assessed once during the screening visit, prior to the experimental test day
Adverse events
Tijdsspanne: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Number and severity of adverse events
Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Daniel Keszthelyi

Onderzoekers

  • Hoofdonderzoeker: Daniel Keszthelyi, MD, PhD, Maastricht University Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

21 maart 2025

Primaire voltooiing (Werkelijk)

12 maart 2026

Studie voltooiing (Werkelijk)

12 maart 2026

Studieregistratiedata

Eerst ingediend

22 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NL87188.068.24

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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