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

NCT07470229 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB202600279
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

transcutaneous vagus nerve stimulation tVNS, stress regulation state anxiety , Trier Social Stress Test, performance

Outcome Measures

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.

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

Study Arms (2)

Active tVNS

EXPERIMENTAL

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.

Device: Transcutaneous Vagus Nerve Stimulation (tVNS); Behavioral: Evaluative Stress Task

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.

Device: Transcutaneous Vagus Nerve Stimulation (tVNS); Behavioral: Evaluative Stress Task

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

Active tVNS; Sham Comparator

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.

Active tVNS; Sham Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adults aged 18 to 65 years
• Fluent in English
• Able to provide informed consent
• Able to complete study procedures during a single laboratory session

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Trevor Foulk, Organizational Behavior

  University of Florida

  STUDY DIRECTOR

• Dustin Hegland, MD-ANESTHESIOLOGY-GENERAL

  University of Florida

  STUDY DIRECTOR

Central Study Contacts

Pedepo Emmanuel, Organizational Behavior

CONTACT

813-834-7991; pedepo.emmanuel@warrington.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to device condition (active vs sham stimulation). Study personnel interacting with participants and collecting outcome data are blinded to condition assignment. Devices are pre-programmed and coded to maintain masking throughout the study.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 2 × 2 between-subjects factorial design crossing device condition (active vs placebo transcutaneous vagus nerve stimulation) and task condition (evaluative stress task vs non-evaluative control task).

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: March 15, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)