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Different Frequency Applications of Transcutaneous Auricular Vagus Nerve Stimulation in Healthy Individuals

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

About this trial

This randomized, participant-blinded, sham-controlled crossover study aims to investigate the acute effects of different frequency applications of transcutaneous auricular vagus nerve stimulation (taVNS) on autonomic physiological responses in healthy adults. Participants will receive sham (0 Hz), 10 Hz, 25 Hz, 50 Hz, and 100 Hz taVNS in separate sessions with washout periods between visits. Heart rate variability, blood pressure, pulse rate, respiratory rate, and subjective discomfort will be assessed before and after each intervention session.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adults aged 18 to 40 years

No known neurological, cardiovascular, respiratory, or metabolic disease

Able to understand study procedures and provide written informed consent

No active infection, open wound, or dermatological lesion in the ear region that would interfere with taVNS application

Disqualifiers

History of cardiac arrhythmia, pacemaker, or any implanted electronic medical device History of hypertension, diabetes, chronic pulmonary disease, epilepsy, or systemic disease affecting autonomic nervous system function

Regular use of medications that may affect autonomic function (e.g., beta-blockers, antidepressants, antiarrhythmics)

Intense physical exercise within the previous 24 hours

High caffeine or alcohol intake within 12 hours prior to assessment

Trial design

Design model

Crossover

Treatments tested in this trial

  • Sham taVNS

    Device

    Sham stimulation is delivered under conditions similar to active taVNS without meaningful vagal stimulation.

  • taVNS 10 Hz

    Device

    Active transcutaneous auricular vagus nerve stimulation applied for 10 minutes at 10 Hz.

  • taVNS 25 Hz

    Device

    Active transcutaneous auricular vagus nerve stimulation applied for 10 minutes at 25 Hz.

  • taVNS 50 Hz

    Device

    Active transcutaneous auricular vagus nerve stimulation applied for 10 minutes at 50 Hz.

  • taVNS 100 Hz

    Device

    Active transcutaneous auricular vagus nerve stimulation applied for 10 minutes at 100 Hz.

Treatment groups

36 Participants
are divided into 5 treatment groups
Group A: Sham taVNSSham comparator 1 intervention
Group B: taVNS 10 HzExperimental treatment 1 intervention
Group C: taVNS 25 HzExperimental treatment 1 intervention
Group D: taVNS 50 HzExperimental treatment 1 intervention
Group E: taVNS 100 HzExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Root Mean Square of Successive Differences (RMSSD)

Change in the root mean square of successive differences (RMSSD) from pre-intervention to post-intervention under each stimulation condition.

Time frame
Immediately before and immediately after each 10-minute intervention session
2

Change in High-Frequency Heart Rate Variability (HF-HRV)

Change in high-frequency heart rate variability (HF-HRV) from pre-intervention to post-intervention under each stimulation condition.

Time frame
Immediately before and immediately after each 10-minute intervention session

Secondary outcomes

1

Change in Standard Deviation of Normal-to-Normal RR Intervals (SDNN)

Change in the standard deviation of normal-to-normal RR intervals (SDNN) from pre-intervention to post-intervention under each stimulation condition.

Time frame
Immediately before and immediately after each 10-minute intervention session
2

Change in Low-Frequency (LF) Power

Change in low-frequency (LF) power of heart rate variability from pre-intervention to post-intervention under each stimulation condition.

Time frame
Immediately before and immediately after each 10-minute intervention session
3

Change in LF/HF Ratio

Change in the ratio of low-frequency to high-frequency heart rate variability (LF/HF ratio) from pre-intervention to post-intervention under each stimulation condition.

Time frame
Immediately before and immediately after each 10-minute intervention session
4

Change in Systolic Blood Pressure

Change in systolic blood pressure from pre-intervention to post-intervention under each stimulation condition.

Time frame
Immediately before and immediately after each 10-minute intervention session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sinop University

Lead sponsor

Source ClinicalTrials.gov

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