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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Active tVNSExperimental treatment 2 interventions
Group B: Sham ComparatorSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Self-Reported Stress

Self-reported stress assessed using a questionnaire/scale administered before and after the performance task to capture changes in perceived stress during the laboratory session.

Time frame
Baseline (pre-task) and immediately post-task during a single laboratory session.

Secondary outcomes

Other outcomes

Sponsors and contacts

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