NCT07526402

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

Investigation of the Acute Effects of Different Frequency Applications of Transcutaneous Auricular Vagus Nerve Stimulation on Autonomic Physiological Responses in Healthy Individuals

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Sinop University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The vagus nerve is a major regulator of the parasympathetic branch of the autonomic nervous system. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique applied to auricular regions innervated by the auricular branch of the vagus nerve. Although taVNS has been reported to modulate autonomic function, the acute physiological effects of different stimulation frequencies remain insufficiently characterized. This study is designed as a randomized, participant-blinded, sham-controlled crossover trial in healthy adults aged 18 to 40 years. Each participant will undergo five intervention conditions in randomized order: sham (0 Hz), 10 Hz, 25 Hz, 50 Hz, and 100 Hz taVNS. Sessions will be separated by 48 to 72 hours to minimize carryover effects. Each stimulation session will last 10 minutes. Primary autonomic outcomes will be derived from heart rate variability parameters obtained using a Polar H10 chest strap and analyzed with Kubios HRV software. Secondary physiological outcomes will include systolic and diastolic blood pressure, pulse rate, respiratory rate, and subjective discomfort measured using a visual analog scale. The study aims to identify frequency-specific autonomic response profiles and to evaluate whether respiratory rate influences heart rate variability changes associated with taVNS.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	Sham taVNS	Sham stimulation is delivered under conditions similar to active taVNS without meaningful vagal stimulation.
DEVICE	taVNS 10 Hz	Active transcutaneous auricular vagus nerve stimulation applied for 10 minutes at 10 Hz.
DEVICE	taVNS 25 Hz	Active transcutaneous auricular vagus nerve stimulation applied for 10 minutes at 25 Hz.
DEVICE	taVNS 50 Hz	Active transcutaneous auricular vagus nerve stimulation applied for 10 minutes at 50 Hz.
DEVICE	taVNS 100 Hz	Active transcutaneous auricular vagus nerve stimulation applied for 10 minutes at 100 Hz.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-05-01
• Completion: 2026-09-01
• First posted: 2026-04-13
• Last updated: 2026-04-16

Locations

1 site across 1 country: Turkey (Türkiye)