Appetite RegulationNCT07444177
Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Appetite
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Appetite Regulation and Food Intake, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study tests a new way to help control appetite. Researchers will use a wearable device on the ear. This device sends gentle electrical pulses to a nerve. This is called vagus nerve stimulation. The main goals of this study are: To see if this device helps people eat less. To check if it lowers feelings of hunger. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite Regulation, Food Intake, Obesity
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jan 2026to 12 Feb 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants aged between 20 and 50 years
- Body Mass Index (BMI) of 20 or higher
- Individuals who are capable of understanding the study procedures and providing voluntary informed consent
Who cannot join
- Presence of implanted metallic or electronic medical devices (e.g., cardiac pacemaker, implantable cardioverter defibrillator (ICD), cardiac stent, deep brain stimulator, or cochlear implant), except for dental implants and artificial joints
- History of diagnosed psychiatric disorders or current use of psychiatric medications
- Moderate to severe depression symptoms, defined as a Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher
- Use of medications or medical interventions that may induce weight changes within the past 3 months
- Active inflammatory or infectious lesions on the ear (e.g., otitis externa, auricular dermatitis, or active skin infection)
- Specific dietary habits or restrictions, such as being a vegan or vegetarian
Show all 10Show fewer
- Known food allergies
- Currently pregnant or breastfeeding
- History of diagnosed diabetes or other endocrine metabolic diseases
- Any other medical condition, illness, or history that, in the investigator's judgment, would make it difficult for the participant to complete the study or complicate the interpretation of study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Food Intake: A Randomized, Double-Blind, Sham-Controlled Crossover Study
This study tests a new way to help control appetite. Researchers will use a wearable device on the ear. This device sends gentle electrical pulses to a nerve. This is called vagus nerve stimulation.
The main goals of this study are:
Read more
- To see if this device helps people eat less.
- To check if it lowers feelings of hunger.
- To measure how it changes responses to food cues.
Healthy adult women will join this study. Each person will have two study visits. At one visit, the device will be turned on. At the other visit, the device will be off. This is a fake or "sham" treatment.
During each visit, researchers will:
- Give a standard meal for 30 minutes.
- Measure how much food each person eats.
- Ask questions about hunger and fullness.
- Use computer tasks to check food cravings.
This study may find a safe, medicine-free way to manage eating habits.
Read the detailed description
Background and Rationale Despite substantial advances in pharmacological treatments for obesity, a considerable proportion of individuals remain non-responsive or intolerant to current medications. This highlights the urgent need for novel, sustainable, and non-pharmacological interventions. Transcutaneous auricular vagus nerve stimulation (taVNS) is an emerging non-invasive electroceutical approach. It targets the vagal afferent pathway to modulate the brain-gut axis, potentially influencing appetite regulation through neurophysiological circuits related to satiety, reward, and interoceptive processing.
Study Protocol and Procedures This study employs a double-blind, sham-controlled, crossover design. Participants will complete two separate experimental visits, separated by a washout period of at least 24 hours to prevent carryover effects. The sequence of the active and sham conditions will be strictly counterbalanced across participants.
During each experimental session, participants will first undergo baseline assessments. Following baseline, the investigational wearable device will be applied to the participant's ear. For the active condition, stimulation will be targeted at the left cymba conchae. The device is programmed with specific technical parameters, including a frequency of 20 Hz, a 50% duty cycle, and an intensity of 1 mA. For the sham condition, the setup will be identical in appearance but will lack the therapeutic electrical dosage to maintain double-blinding for both the investigator and the participant.
The designated stimulation (active or sham) will be delivered continuously for exactly 30 minutes. Concurrently with the stimulation, participants will be presented with a standardized, ad libitum buffet-style test meal. Immediately following the 30-minute eating and stimulation session, participants will engage in a series of computerized cognitive-behavioral tasks and state-assessment surveys designed to capture neurocognitive responses to food cues and interoceptive awareness.
- Conditions
- Appetite Regulation, Food Intake, Obesity, Eating Behaviour
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Sham Stimulation
- Medical subject headings
- Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Device
A single 30-minute session of active taVNS (20 Hz, 1 mA, 50% duty cycle) will be administered to the left cymba conchae. As this is a crossover study, each participant receives this intervention once during their assigned active period.
Sham StimulationDevice
A single 30-minute session of sham stimulation will be administered at the same location (left cymba conchae). The device is applied for 30 minutes with the same visual and tactile setup, but no effective electrical stimulation is delivered. This is performed once during the participant's assigned sham period.
| Study group | Role | What they receive |
|---|---|---|
| Active then Sham | Experimental | Participants receive a single 30-minute session of active taVNS in the first period. Following a washout period of at least 24 hours to prevent carry-over effects, they return for a second visit to receive a single 30-minute session of sham stimulation. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Device: Sham Stimulation |
| Sham then Active | Experimental | Participants receive a single 30-minute session of sham stimulation in the first period. Following a washout period of at least 24 hours, they return for a second visit to receive a single 30-minute session of active taVNS. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Food Intake
The amount of food consumed during an ad libitum buffet meal (standardized Gimbap). It is calculated as the difference in the weight of food (grams) consumed between the active taVNS session and the sham stimulation session.
Measured: During the 30-minute ad libitum meal session in each experimental visit
Secondary outcomes (5)
custom-developed Interoceptive State Appetite Scale (VAS-100)
Subjective states of hunger, fullness, and desire to eat are assessed using the 15-item Interoceptive State Appetite Scale (VAS-100). Each of the 15 items is evaluated on a 0 to 100 scale, where higher scores indicate greater intensity of the felt state. All 15 items share the identical unit of measure (VAS score, 0-100) and will not be aggregated into a composite score. Instead, the individual score for each of the 15 items will be reported separately to evaluate their independent changes.
Measured: Baseline (pre-stimulation) and immediately after the 30-minute stimulation/meal session.
Eating-Related Interoceptive Awareness
This measure assesses the participant's ability to perceive and respond to internal bodily signals related to hunger, satiety, and food intake control using a 7-item questionnaire. Six items are rated on a 5-point Likert scale (1-5), and one item is rated on a 6-point Likert scale (1-6). The individual score for each of the 7 items will be analyzed and reported separately.
Measured: Immediately after the ad libitum buffet meal and the final VAS-100 appetite assessment in each experimental session.
Attentional Bias Toward Food Stimuli
Attentional bias measured via a Dot-probe task. It is calculated based on the difference in reaction times (ms) between dots replacing food images versus neutral images.
Measured: Immediately after the 30-minute stimulation/meal session.
Inhibitory Control Toward Food Cues: False Alarm Rate
Performance on a Go/No-Go task to measure response inhibition toward food-related stimuli. The specific indicator is the False Alarm Rate, defined as the proportion of incorrect responses during No-Go trials. To evaluate the intervention effect, the difference in False Alarm Rates between the active stimulation session and the sham session will be calculated and analyzed using a paired t-test.
Measured: Immediately after dot probe task
Inhibitory Control Toward Food Cues: d-prime
Performance on a Go/No-Go task to measure signal detection sensitivity and response inhibition toward food-related stimuli. The specific indicator is the $d'$ (d-prime) index, calculated based on the standardized hit rates and false alarm rates. To evaluate the intervention effect, the difference in $d'$ values between the active stimulation session and the sham session will be calculated and analyzed using a paired t-test.
Measured: Immediately after the Dot-probe task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start12 Jan 2026
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetite RegulationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyung Jin Choi, MD, PhD, Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444177
- Sponsor's protocol ID
- 2506-159-1654
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect the privacy of the participants and to comply with the institutional review board (IRB) approval, which does not include a provision for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Food Intake: A Randomized, Double-Blind, Sham-Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT07444177
- Acronym / sponsor ID
- 2506-159-1654
- Conditions
- Appetite Regulation, Food Intake, Obesity, Eating Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 2 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 tests a new way to help control appetite. Researchers will use a wearable device on the ear. This device sends gentle electrical pulses to a nerve. This is called vagus nerve stimulation.
The main goals of this study are:
- To see if this device helps people eat less.
- To check if it lowers feelings of hunger.
- To measure how it changes responses to food cues.
Healthy adult women will join this study. Each person will have two study visits. At one visit, the device will be turned on. At the other visit, the device will be off. This is a fake or "sham" treatment.
During each visit, researchers will:
- Give a standard meal for 30 minutes.
- Measure how much food each person eats.
- Ask questions about hunger and fullness.
- Use computer tasks to check food cravings.
This study may find a safe, medicine-free way to manage eating habits.
Detailed description
Background and Rationale Despite substantial advances in pharmacological treatments for obesity, a considerable proportion of individuals remain non-responsive or intolerant to current medications. This highlights the urgent need for novel, sustainable, and non-pharmacological interventions. Transcutaneous auricular vagus nerve stimulation (taVNS) is an emerging non-invasive electroceutical approach. It targets the vagal afferent pathway to modulate the brain-gut axis, potentially influencing appetite regulation through neurophysiological circuits related to satiety, reward, and interoceptive processing.
Study Protocol and Procedures This study employs a double-blind, sham-controlled, crossover design. Participants will complete two separate experimental visits, separated by a washout period of at least 24 hours to prevent carryover effects. The sequence of the active and sham conditions will be strictly counterbalanced across participants.
During each experimental session, participants will first undergo baseline assessments. Following baseline, the investigational wearable device will be applied to the participant's ear. For the active condition, stimulation will be targeted at the left cymba conchae. The device is programmed with specific technical parameters, including a frequency of 20 Hz, a 50% duty cycle, and an intensity of 1 mA. For the sham condition, the setup will be identical in appearance but will lack the therapeutic electrical dosage to maintain double-blinding for both the investigator and the participant.
The designated stimulation (active or sham) will be delivered continuously for exactly 30 minutes. Concurrently with the stimulation, participants will be presented with a standardized, ad libitum buffet-style test meal. Immediately following the 30-minute eating and stimulation session, participants will engage in a series of computerized cognitive-behavioral tasks and state-assessment surveys designed to capture neurocognitive responses to food cues and interoceptive awareness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active then Sham | Experimental | Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Device: Sham StimulationParticipants receive a single 30-minute session of active taVNS in the first period. Following a washout period of at least 24 hours to prevent carry-over effects, they return for a second visit to receive a single 30-minute session of sham stimulation. |
| Sham then Active | Experimental | Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Device: Sham StimulationParticipants receive a single 30-minute session of sham stimulation in the first period. Following a washout period of at least 24 hours, they return for a second visit to receive a single 30-minute session of active taVNS. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female participants aged between 20 and 50 years
- Body Mass Index (BMI) of 20 or higher
- Individuals who are capable of understanding the study procedures and providing voluntary informed consent
Key exclusion criteria (10 listed)
- Presence of implanted metallic or electronic medical devices (e.g., cardiac pacemaker, implantable cardioverter defibrillator (ICD), cardiac stent, deep brain stimulator, or cochlear implant), except for dental implants and artificial joints
- History of diagnosed psychiatric disorders or current use of psychiatric medications
- Moderate to severe depression symptoms, defined as a Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher
- Use of medications or medical interventions that may induce weight changes within the past 3 months
- Active inflammatory or infectious lesions on the ear (e.g., otitis externa, auricular dermatitis, or active skin infection)
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 Auricular Vagus Nerve Stimulation (taVNS)A single 30-minute session of active taVNS (20 Hz, 1 mA, 50% duty cycle) will be administered to the left cymba conchae. As this is a crossover study, each participant receives this intervention once during their assigned active period. | Device | Active then Sham, Sham then Active |
| Sham StimulationA single 30-minute session of sham stimulation will be administered at the same location (left cymba conchae). The device is applied for 30 minutes with the same visual and tactile setup, but no effective electrical stimulation is delivered. This is performed once during the participant's assigned sham period. | Device | Active then Sham, Sham then Active |
Primary outcome
Difference in Food Intake
Time frame: During the 30-minute ad libitum meal session in each experimental visit
The amount of food consumed during an ad libitum buffet meal (standardized Gimbap). It is calculated as the difference in the weight of food (grams) consumed between the active taVNS session and the sham stimulation session.
5 secondary outcomes
custom-developed Interoceptive State Appetite Scale (VAS-100)
Time frame: Baseline (pre-stimulation) and immediately after the 30-minute stimulation/meal session.
Eating-Related Interoceptive Awareness
Time frame: Immediately after the ad libitum buffet meal and the final VAS-100 appetite assessment in each experimental session.
Attentional Bias Toward Food Stimuli
Time frame: Immediately after the 30-minute stimulation/meal session.
Inhibitory Control Toward Food Cues: False Alarm Rate
Time frame: Immediately after dot probe task
Inhibitory Control Toward Food Cues: d-prime
Time frame: Immediately after the Dot-probe task
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 4 Mar 2026.
- Individual participant dataSharing planned: No. IPD will not be shared to protect the privacy of the participants and to comply with the institutional review board (IRB) approval, which does not include a provision for public data sharing.
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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.
Hyung Jin Choi, MD, PhD principal investigator
Seoul National University College of Medicine
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 Auricular Vagus Nerve Stimulation (taVNS) in people with Appetite Regulation and Food Intake, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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 South Korea. 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. 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?
Difference in Food Intake (time frame: During the 30-minute ad libitum meal session in each experimental visit). 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 4 Mar 2026.