Stress ResponseNCT07470229
Transcutaneous Vagus Nerve Stimulation (tVNS) and Stress Regulation During Performance Tasks
A study testing Transcutaneous Vagus Nerve Stimulation (tVNS) and Evaluative Stress Task in people with Stress Response, run by University of Florida at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Response
- What is being tested?
- Transcutaneous Vagus Nerve Stimulation (tVNS) and Evaluative Stress Task
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2026to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years
- Fluent in English
- Able to provide informed consent
- Able to complete study procedures during a single laboratory session
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Florida
Gainesville, Florida, 32611
Trevor Foulk, PhD in Management, 301-807-0397, Trevor.foulk@warrington.ufl.edu
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Stress Response
- Being tested
- Transcutaneous Vagus Nerve Stimulation (tVNS), Evaluative Stress Task
- Keywords
- transcutaneous vagus nerve stimulation tVNS, stress regulation state anxiety , Trier Social Stress Test, performance
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 TaskBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcutaneous Vagus Nerve Stimulation (tVNS); Behavioral: Evaluative Stress Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-task) and immediately post-task during a single laboratory session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ResponseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trevor Foulk, Organizational Behavior, Study director, University of FloridaDustin Hegland, MD-ANESTHESIOLOGY-GENERAL, Study director, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470229
- Sponsor's protocol ID
- IRB202600279
- Status last verified
- Feb 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared due to confidentiality considerations and institutional data protection policies. Although research data will be de-identified and stored securely, there are no current plans to make individual-level data publicly available. Aggregate results may be reported in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Vagus Nerve Stimulation (tVNS) and Stress Regulation During Performance Tasks
- ClinicalTrials.gov ID
- NCT07470229
- Acronym / sponsor ID
- IRB202600279
- Conditions
- Stress Response
- Keywords
- transcutaneous vagus nerve stimulation tVNS, stress regulation state anxiety , Trier Social Stress Test, performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Active tVNS | Experimental | Device: Transcutaneous Vagus Nerve Stimulation (tVNS), Behavioral: Evaluative Stress TaskParticipants 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 | Device: Transcutaneous Vagus Nerve Stimulation (tVNS), Behavioral: Evaluative Stress TaskParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 65 years
- Fluent in English
- Able to provide informed consent
- Able to complete study procedures during a single laboratory session
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Active tVNS, Sham Comparator |
| Evaluative Stress TaskParticipants 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. | Behavioural | Active tVNS, Sham Comparator |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to confidentiality considerations and institutional data protection policies. Although research data will be de-identified and stored securely, there are no current plans to make individual-level data publicly available. Aggregate results may be reported in publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trevor Foulk, Organizational Behavior study director
University of Florida
Dustin Hegland, MD-ANESTHESIOLOGY-GENERAL study director
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Vagus Nerve Stimulation (tVNS) and Evaluative Stress Task in people with Stress Response, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedepo Emmanuel, Organizational Behavior (813-834-7991, pedepo.emmanuel@warrington.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Stress (time frame: Baseline (pre-task) and immediately post-task during a single laboratory session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.