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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07470229
Status
Not Yet Recruiting

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Conditions

  • Stress Response

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Transcutaneous Vagus Nerve Stimulation (tVNS) — DEVICE
    Transcutaneous vagus nerve stimulation delivered via an auricular stimulation device. Participants receive either active stimulation or sham stimulation depending on random assignment
  • Evaluative Stress Task — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 15, 2026
Status verified
Feb 2026
Primary completion
Apr 15, 2026
Completion
Apr 15, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Active tVNS
    Participants receive active transcutaneous vagus nerve stimulation (tVNS). Participants also complete either an evaluative stress task or a non-evaluative control task as part of the factorial design.
  • Sham Comparator: Sham Comparator
    Participants receive sham transcutaneous vagus nerve stimulation. Participants also complete either an evaluative stress task or a non-evaluative control task as part of the factorial design.

Primary Outcome Measure

Self-Reported Stress [ Time Frame: Baseline (pre-task) and immediately post-task during a single laboratory session. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611
Trevor Foulk, PhD in Management
[email protected]
301-807-0397

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By research site
University of Florida· Gainesville, FL

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