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NCT Number: NCT07470229

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Location contact

Trevor Foulk, PhD in Management

CONTACT

[email protected]

301-807-0397

About this study

This study is a laboratory-based, randomized, double-blind experiment designed to examine whether non-invasive transcutaneous vagus nerve stimulation (tVNS) influences state anxiety and physiological arousal during performance-related stress.

Participants will be randomly assigned to one of four conditions in a 2 × 2 between-subjects factorial design:

Device Condition:

Active tVNS

Placebo (inactive) tVNS

Task Condition:

Stress Task (Modified Trier Social Stress Test speech preparation)

Control Task (Non-evaluative writing task)

The device condition is double blind. Half of the devices are configured by the manufacturer to deliver active stimulation to the auricular branch of the vagus nerve via the left ear. The remaining devices are configured to deliver brief initial stimulation that ramps down to zero (placebo condition). Neither participants nor experimenters are aware of device assignment during the session.

After informed consent and baseline measures, participants complete a quiet baseline period during which heart rate and state anxiety are assessed. Participants then wear the tVNS device during structured laboratory tasks.

In the stress condition, participants are instructed to prepare a five-minute speech to be delivered before evaluators and recorded for assessment. The preparation phase is modeled after the Trier Social Stress Test and is designed to induce anticipatory evaluative stress. The speech is not ultimately delivered. State anxiety and heart rate are measured during preparation and immediately afterward.

In the control condition, participants complete a non-evaluative writing task on the same topic without evaluative framing. Physiological and self-report measures are collected at matched time points.

The primary outcome measure is state anxiety assessed using the short-form State-Trait Anxiety Inventory (STAI). Secondary outcomes include heart rate measured during baseline, task preparation, and recovery periods. Additional measures include dispositional stress reactivity, which will be examined as a potential moderator of stimulation effects.

The study is designed to determine whether active tVNS reduces subjective anxiety and physiological arousal during evaluative stress compared to placebo stimulation and to assess whether effects differ as a function of individual differences in stress reactivity.

Participation consists of a single laboratory session lasting approximately 45 minutes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 65 years

Fluent in English

Able to provide informed consent

Able to complete study procedures during a single laboratory session

Exclusion criteria

  • History of neurological or psychiatric disorders

Cardiovascular disease or uncontrolled hypertension

Implanted electrical devices (e.g., pacemaker)

Current pregnancy

Contraindications to transcutaneous vagus nerve stimulation (tVNS)

Current use of medications that significantly affect autonomic nervous system functioning

Treatment and study plan

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.

Primary outcomes

  1. Self-Reported Stress

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pedepo Emmanuel, Organizational Behavior

CONTACT

[email protected]

813-834-7991

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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