Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07628842
NA

Exploring the Effect of taVNS on the Acute Stress Responses

Sponsor: Daniel Keszthelyi

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-03-21

Completion Date

2026-03-12

Last Updated

2026-06-05

Healthy Volunteers

Yes

Interventions

DEVICE

Vagal Nerve Stimulation

Transcutaneous Auricular Vagal Nerve Stimulation

DEVICE

Sham stimulation

Sham stimulation with a non-conducting electrode

Locations (1)

Maastricht University

Maastricht, Limburg, Netherlands