Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insulin Levels

This study is looking at whether a device called Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) can change insulin, C-peptide (a substance made when insulin is produced), and glucose (sugar) levels in healthy adults. Researchers will place electrodes on your ear to deliver mild stimulation to the vagus nerve, which runs from your brain to your large intestine and controls many body functions. You might be in a group that receives stimulation or a group that doesn't, but thinks they are. The goal is to see if stimulating this nerve can affect insulin levels, which could help people with nausea, vomiting, stomach problems, or diabetes in the future. We are looking for healthy volunteers aged 18-70.

Study design
This interventional study plans to enroll 30 healthy adult participants. You will be assigned to either a stimulation group or a sham group, where you believe you are receiving stimulation but are not.
What's involved
You will need to be willing to have ECG electrodes placed on your neck and chest, electrodes placed in your external ear, and an indwelling catheter for blood draws. The primary measurements will be taken at one month.
Compensation
Not stated in the trial record.
Follow-up
Your plasma insulin, C-peptide, and glucose levels will be measured at one month after the stimulation.

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NCT06597149

Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Plasma Insulin Levels

Recruiting
NAAges 18–70Interventional
Indiana University
~30 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Transcutaneous Auricular Vagus Nerve Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Association between acute transcutaneous auricular vagus nerve stimulation and change in plasma insulin levels
Measured over one month
+6 more outcomes measured
Healthy
1 sites across 1 states
Indiana1
  • Thomas V Nowak, MD · PRINCIPAL_INVESTIGATOR · IU Medical Scool

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Eligibility criteria

Inclusion

Healthy Volunteers
Aged 18-70
Willing to have ECG electrodes placed on their neck and chest areas.
Willing to have electrodes placed in the external ear.
Willing to have an indwelling catheter placed to avoid multiple sticks for blood draw.

Exclusion

Unable to provide consent.
Diabetes diagnosis per patient report
Having known allergies to adhesive on electrode pads or bandages
Having gastric motility issues as determined by the PI or clinical coordinator.
Taking any medications that may affect gastric motility or cardiac variability, i.e. alpha or beta blockers for hypertension.
Pregnant females
Those unwilling to have the taVNS device placed in their ear.
Those unwilling to consent to a blood draw.
Prisoners
  • Association between acute transcutaneous auricular vagus nerve stimulation and change in plasma insulin levelsone month

    Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on plasma insulin levels.

  • Association between acute transcutaneous auricular vagus nerve stimulation and change in C-peptide levelsone month

    \- Measure description: Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on C-peptide levels.

  • Association between acute transcutaneous auricular vagus nerve stimulation and change in glucose levelsone month

    Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on glucose levels

  • Association between acute transcutaneous auricular vagus nerve stimulation and heart rate variabilityone month

    Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on heart rate variability.

  • Association between changes in heart rate variability and plasma insulin levelsone month

    Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in plasma insulin levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.

  • Association between changes in heart rate variability and C-peptide levelsone month

    Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in C-peptide levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.

  • Association between changes in heart rate variability and glucose levelsone month

    Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in glucose levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.