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Exploring the Effect of taVNS on the Acute Stress Responses

1 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Olanda
    • Limburg
      • Maastricht, Limburg, Olanda, 6229ER
        • Maastricht University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Transcutaneous Auricular Vagal Nerve Stimulation
Transcutaneous auricular vagal nerve stimulation, for 30 minutes
Dispositivo: Stimolazione del nervo vagale
Stimolazione transcutanea del nervo vagale auricolare
Comparatore placebo: Sham stimulation
Sham stimulation with a non-conducting electrode, for 30 minutes
Dispositivo: Sham stimulation
Sham stimulation with a non-conducting electrode

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Neuroendocrine stress response
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Subjective stress response
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Daniel Keszthelyi

Investigatori

  • Investigatore principale: Daniel Keszthelyi, MD, PhD, Maastricht University Medical Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 marzo 2025

Completamento primario (Effettivo)

12 marzo 2026

Completamento dello studio (Effettivo)

12 marzo 2026

Date di iscrizione allo studio

Primo inviato

22 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

5 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NL87188.068.24

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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