NCT07444177

Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Appetite

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Food Intake: A Randomized, Double-Blind, Sham-Controlled Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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. * 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.

Conditions

• Appetite Regulation
• Food Intake
• Obesity
• Eating Behaviour

Interventions

Type	Name	Description
DEVICE	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	Sham Stimulation	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.

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-02-12
• Completion: 2026-02-12
• First posted: 2026-03-02
• Last updated: 2026-03-04

Locations

1 site across 1 country: South Korea