Healthy Adult ParticipantsNCT07628842
Exploring the Effect of taVNS on the Acute Stress Responses
A study testing Vagal Nerve Stimulation in people with Healthy Adult Participants, run by Daniel Keszthelyi at 1 site in Netherlands.
Trial summary
This single-center randomized controlled trial aims to investigate the effects of transcutaneous auricular vagus nerve stimulation on the acute stress responses. The primary aim of this study is to assess the efficacy of taVNS in mitigating the acute stress response induced by the Maastricht Acute Stress Task (MAST)… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Vagal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Mar 2025to 12 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy participants (defined as those without a pre-existing medical comorbidity)
- Aged between 18-65 years
- Ability to understand and speak the Dutch language.
Who cannot join
- Medical history or condition affecting the cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, haematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric systems, as well as prior major surgeries or ongoing laboratory abnormalities that could potentially limit participation or completion of the study protocol;
- Any use of medication, especially those that may influence the autonomic nervous system or the hypothalamus-pituitary-adrenal axis (e.g., beta-agonists or corticosteroids), with the exception of contraceptives and paracetamol;
- Current or lifetime psychopathology (including PHQ-9 and GHD-7 scores > 10);
- Substance abuse (including excessive alcohol consumption);
- Smoking;
- Pregnancy, lactation, or intention to become pregnant during the study period;
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- Use of devices (e.g., cochlear implants) or other reasons (e.g. wounds, permanent ear-piercing) which complicate the use of the tVNS device;
- Participation in another clinical study in which the MAST was used;
- Administration of investigational drugs or participation in any scientific intervention study that might interfere with this study (to be determined by the principal investigator) within 180 days preceding the commencement of the study;
- Students and employees of Maastricht University are not precluded from participation, unless they have a direct personal, professional or hierarchical position with regards to any of the study team members or their department.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on the Acute Stress Responses: a Double-blind Randomized Controlled Trial
This single-center randomized controlled trial aims to investigate the effects of transcutaneous auricular vagus nerve stimulation on the acute stress responses.
The primary aim of this study is to assess the efficacy of taVNS in mitigating the acute stress response induced by the Maastricht Acute Stress Task (MAST) among healthy subjects, measured by cortisol levels in saliva samples.
Read more
Secondary objectives include:
- Evaluating taVNS's potential to counteract stress-induced sympathetic activation and thereby alleviate stress-related effects, including negative affect, as measuring using the I-PANAS-SF questionnaire, and feelings of stress, pain, and unpleasantness, as measured with 0-100 Visual Analog Scales (VAS)
- Assessing its impact on autonomic outflow parameters, using a blood pressure monitor for blood pressure, and a FitBit smartwatch for heart rate variability, and Shimmer3 GSR sensor for heart rate variability and skin conductance.
- Evaluating the relationship between stress responses and affective symptoms and personality traits, utilizing the Generalized Anxiety Disorder 7-Item Scale (GAD-7), Patient Health Questionnaire (PHQ-9), and the Big Five Inventory (BFI).
Participants will be randomly assigned to either the taVNS or sham stimulation group, administered 30 minutes before the MAST.
- Conditions
- Healthy Adult Participants
- Being tested
- Vagal Nerve Stimulation, Sham stimulation
- Keywords
- Vagal Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagal Nerve StimulationDevice
Transcutaneous Auricular Vagal Nerve Stimulation
Sham stimulationDevice
Sham stimulation with a non-conducting electrode
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Auricular Vagal Nerve Stimulation | Active comparator | Transcutaneous auricular vagal nerve stimulation, for 30 minutes Receives: Device: Vagal Nerve Stimulation |
| Sham stimulation | Placebo comparator | Sham stimulation with a non-conducting electrode, for 30 minutes Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroendocrine stress response
A significant reduction in the neuroendocrine stress response triggered by the MAST following taVNS or sham treatment, assessed through saliva cortisol samples, with a defined threshold of a 35% decrease.
Measured: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Secondary outcomes (8)
Subjective stress response
Subjective stress responses to the MAST following taVNS or sham treatment, assessed using the negative affect subscale of the International Positive and Negative Affect Schedule Short Form (I-PANAS-SF; total score range: 5-25, with higher scores indicating greater negative affect) and 0-100 Visual Analog Scales (VAS) for stress, pain, and unpleasantness (0=not at all, 100=extremely; higher scores indicate greater perceived stress, pain, or unpleasantness).
Measured: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Cardiovascular stress response - blood pressure
Changes in systolic and diastolic blood pressure responses to the Maastricht Acute Stress Test (MAST) following transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation, assessed in mmHg. Blood pressure was measured four times.
Measured: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Autonomic stress response: heart rate variability
Changes in heart rate variability responses to the Maastricht Acute Stress Test (MAST) following transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation, assessed using Fitbit and Shimmer3 GSR. Heart rate variability was measured continuously during the test day.
Measured: Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Electrodermal stress response: skin conductance
Changes in skin conductance responses to the Maastricht Acute Stress Test (MAST) following transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation, assessed in microsiemens (µS).
Measured: Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Anxiety symptoms
Anxiety symptoms assessed using the Generalized Anxiety Disorder-7 questionnaire (GAD-7; total score range: 0-21, with higher scores indicating greater anxiety symptom severity).
Measured: Assessed once during the screening visit, prior to the experimental test day
Depressive symptoms
Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9; total score range: 0-27, with higher scores indicating greater depressive symptom severity).
Measured: Assessed once during the screening visit, prior to the experimental test day
Personality traits
Personality traits assessed using the Big Five Inventory-44 (BFI-44). The BFI-44 measures five personality domains (Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Openness to Experience). Each domain score is computed as a sum or mean of item responses on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), with higher scores indicating greater expression of the respective personality trait.
Measured: Assessed once during the screening visit, prior to the experimental test day
Adverse events
Number and severity of adverse events
Measured: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start21 Mar 2025
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Keszthelyi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Keszthelyi, Academisch Ziekenhuis Maastricht
- Investigators
- Daniel Keszthelyi, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628842
- Sponsor's protocol ID
- NL87188.068.24
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on the Acute Stress Responses: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07628842
- Acronym / sponsor ID
- NL87188.068.24
- Conditions
- Healthy Adult Participants
- Keywords
- Vagal Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Daniel KeszthelyiUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 5 Jun 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 single-center randomized controlled trial aims to investigate the effects of transcutaneous auricular vagus nerve stimulation on the acute stress responses.
The primary aim of this study is to assess the efficacy of taVNS in mitigating the acute stress response induced by the Maastricht Acute Stress Task (MAST) among healthy subjects, measured by cortisol levels in saliva samples.
Secondary objectives include:
- Evaluating taVNS's potential to counteract stress-induced sympathetic activation and thereby alleviate stress-related effects, including negative affect, as measuring using the I-PANAS-SF questionnaire, and feelings of stress, pain, and unpleasantness, as measured with 0-100 Visual Analog Scales (VAS)
- Assessing its impact on autonomic outflow parameters, using a blood pressure monitor for blood pressure, and a FitBit smartwatch for heart rate variability, and Shimmer3 GSR sensor for heart rate variability and skin conductance.
- Evaluating the relationship between stress responses and affective symptoms and personality traits, utilizing the Generalized Anxiety Disorder 7-Item Scale (GAD-7), Patient Health Questionnaire (PHQ-9), and the Big Five Inventory (BFI).
Participants will be randomly assigned to either the taVNS or sham stimulation group, administered 30 minutes before the MAST.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Auricular Vagal Nerve Stimulation | Active comparator | Device: Vagal Nerve StimulationTranscutaneous auricular vagal nerve stimulation, for 30 minutes |
| Sham stimulation | Placebo comparator | Device: Sham stimulationSham stimulation with a non-conducting electrode, for 30 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy participants (defined as those without a pre-existing medical comorbidity)
- Aged between 18-65 years
- Ability to understand and speak the Dutch language.
Key exclusion criteria (10 listed)
- Medical history or condition affecting the cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, haematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric systems, as well as prior major surgeries or ongoing laboratory abnormalities that could potentially limit participation or completion of the study protocol;
- Any use of medication, especially those that may influence the autonomic nervous system or the hypothalamus-pituitary-adrenal axis (e.g., beta-agonists or corticosteroids), with the exception of contraceptives and paracetamol;
- Current or lifetime psychopathology (including PHQ-9 and GHD-7 scores > 10);
- Substance abuse (including excessive alcohol consumption);
- Smoking;
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 |
|---|---|---|
| Vagal Nerve StimulationTranscutaneous Auricular Vagal Nerve Stimulation | Device | Transcutaneous Auricular Vagal Nerve Stimulation |
| Sham stimulationSham stimulation with a non-conducting electrode | Device | Sham stimulation |
Primary outcome
Neuroendocrine stress response
Time frame: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
A significant reduction in the neuroendocrine stress response triggered by the MAST following taVNS or sham treatment, assessed through saliva cortisol samples, with a defined threshold of a 35% decrease.
8 secondary outcomes
Subjective stress response
Time frame: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Cardiovascular stress response - blood pressure
Time frame: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Autonomic stress response: heart rate variability
Time frame: Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Electrodermal stress response: skin conductance
Time frame: Assessed during a single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Anxiety symptoms
Time frame: Assessed once during the screening visit, prior to the experimental test day
Depressive symptoms
Time frame: Assessed once during the screening visit, prior to the experimental test day
Personality traits
Time frame: Assessed once during the screening visit, prior to the experimental test day
Adverse events
Time frame: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Daniel Keszthelyi, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagal Nerve Stimulation in people with Healthy Adult Participants, run by Daniel Keszthelyi at 1 site in Netherlands.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 5 Jun 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroendocrine stress response (time frame: Assessed during one single test day, from pre-intervention baseline to post-MAST assessment (approximately 2-3 hours)). 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 5 Jun 2026.