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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorSinop University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active taVNS

    Device

    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

    Device

    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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Active taVNSExperimental treatment 1 intervention
Group B: Sham stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in RMSSD

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.

Time frame
[Time Frame: Baseline (pre-intervention) and immediately after intervention, at each study visit (5, 10, and 15 minutes)]
2

Change in high-frequency heart rate variability (HF-HRV)

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.

Time frame
[Time Frame: Baseline (pre-intervention) and immediately after intervention, at each study visit (5, 10, and 15 minutes)]

Secondary outcomes

1

Change in heart rate

Change in heart rate from pre-intervention to post-intervention after active taVNS or sham stimulation at each study visit.

Time frame
[Time Frame: Baseline (pre-intervention) and immediately after intervention, at each study visit (5, 10, and 15 minutes)]
2

Change in systolic blood pressure

Change in systolic blood pressure from pre-intervention to post-intervention after active taVNS or sham stimulation at each study visit.

Time frame
[Time Frame: Baseline (pre-intervention) and immediately after intervention, at each study visit (5, 10, and 15 minutes)]
3

Change in diastolic blood pressure

Change in diastolic blood pressure from pre-intervention to post-intervention after active taVNS or sham stimulation at each study visit.

Time frame
[Time Frame: Baseline (pre-intervention) and immediately after intervention, at each study visit (5, 10, and 15 minutes)]
4

Change in respiratory rate

Change in respiratory rate from pre-intervention to post-intervention after active taVNS or sham stimulation at each study visit.

Time frame
[Time Frame: Baseline (pre-intervention) and immediately after intervention, at each study visit (5, 10, and 15 minutes)]

Other outcomes

Sponsors and contacts

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