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Transcutaneous Vagus Nerve Stimulation (tVNS) and Stress Regulation During Performance Tasks

NCT07470229 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-13

No results posted yet for this study

Summary

This study examines how individuals respond to performance-related tasks and whether a non-invasive ear stimulation device influences stress responses during those tasks. Participants will be randomly assigned to use either an active or inactive (placebo) version of a transcutaneous vagus nerve stimulation (tVNS) device during a laboratory session.

The study includes two task conditions. In one condition, participants will prepare a brief speech under evaluative conditions designed to induce stress. In the other condition, participants will complete a non-evaluative writing task. During the session, participants will wear a heart rate monitor and complete short questionnaires assessing their current feelings, including state anxiety.

The primary objective is to determine whether active tVNS is associated with lower state anxiety during a performance-related stress task compared to placebo stimulation. Secondary outcomes include heart rate and task-related responses. The study will also examine whether individual differences in stress reactivity influence responses to stimulation.

Participation involves one laboratory session lasting approximately 45 minutes.

Conditions

  • Stress Response

Interventions

DEVICE

Transcutaneous Vagus Nerve Stimulation (tVNS)

Transcutaneous vagus nerve stimulation delivered via an auricular stimulation device. Participants receive either active stimulation or sham stimulation depending on random assignment

BEHAVIORAL

Evaluative Stress Task

Participants complete either an evaluative stress-induction task involving social evaluation or a non-evaluative control task. Task condition is assigned as part of the factorial design.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Trevor Foulk, Organizational Behavior · University of Florida

  • Dustin Hegland, MD-ANESTHESIOLOGY-GENERAL · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2026-04-15
Completion
2026-04-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07470229 on ClinicalTrials.gov