Non-Invasive Transcutaneous Auricular Vagus Nerve Stimulation Applied at Different Durations in Healthy Adults

Condition(s) studied

Investigational drug(s) / intervention(s)

Active taVNS: Active transcutaneous auricular vagus nerve stimulation will be applied bilaterally to the cymba conchae region. Stimulation frequency will be 25 Hz, pulse width 200 to 300 microseconds, and intensity will be individually adjusted to a clearly perceptible but comfortable level. Depending on the study visit, stimulation will be delivered for 5, 10, or 15 minutes.

Sham stimulation: Sham stimulation will be delivered using the same device under visually similar conditions. The sham procedure will be applied at a non-vagal auricular site or with minimal non-therapeutic stimulation, depending on the study protocol, for 5, 10, or 15 minutes according to the study visit.

Study summary

This randomized, participant-blinded, sham-controlled interventional study aims to compare the acute effects of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) applied at different durations on autonomic nervous system responses in healthy adults. Participants will be assigned to either an active taVNS group or a sham stimulation group. Within each group, participants will complete three separate study visits in which stimulation will be applied for 5, 10, and 15 minutes in randomized order, with 48- to 72-hour washout intervals between visits. Heart rate variability, heart rate, blood pressure, respiratory rate, and subjective discomfort will be assessed immediately before and after each intervention session. The study is designed to determine whether the acute autonomic effects of taVNS vary according to stimulation duration and whether a duration-related response pattern can be identified.

Eligibility

Primary outcome measure(s)

• Change in RMSSD — [Time Frame: Baseline (pre-intervention) and immediately after intervention, at each study visit (5, 10, and 15 minutes)]
  Change in the root mean square of successive differences (RMSSD), derived from RR interval recordings, from pre-intervention (T0) to post-intervention (T1) after active taVNS or sham stimulation at 5, 10, and 15 minutes.
• Change in high-frequency heart rate variability (HF-HRV) — [Time Frame: Baseline (pre-intervention) and immediately after intervention, at each study visit (5, 10, and 15 minutes)]
  Change in high-frequency heart rate variability (HF-HRV) from pre-intervention (T0) to post-intervention (T1) after active taVNS or sham stimulation at 5, 10, and 15 minutes.

Trial sites (1)

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