Investigation of the Acute Effects of Different Frequency Applications of Transcutaneous Auricular Vagus Nerve Stimulation on Autonomic Physiological Responses in Healthy Individuals
| Registry | NCT07526402, acronym taVNS-FREQ |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: single, basic science |
| Enrollment | 36 (Estimated) |
| Sponsor | Sinop University (Other) |
| Conditions | Healthy Volunteers |
| Interventions | Sham taVNS, taVNS 10 Hz, taVNS 25 Hz, taVNS 50 Hz, taVNS 100 Hz (Device) |
| Dates | start 2026-05-01 (estimated), primary completion 2026-05-01 (estimated), completion 2026-09-01 (estimated), first posted 2026-04-13, last updated 2026-04-16 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Volunteers All trials of Sham taVNS All trials of taVNS 10 Hz
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sham taVNS | Sham comparator | Device: Sham taVNS | Participants receive sham stimulation during one study session. |
| taVNS 10 Hz | Experimental | Device: taVNS 10 Hz | Participants receive active transcutaneous auricular vagus nerve stimulation at 10 Hz during one study session. |
| taVNS 25 Hz | Experimental | Device: taVNS 25 Hz | Participants receive active transcutaneous auricular vagus nerve stimulation at 25 Hz during one study session. |
| taVNS 50 Hz | Experimental | Device: taVNS 50 Hz | Participants receive active transcutaneous auricular vagus nerve stimulation at 50 Hz during one study session. |
| taVNS 100 Hz | Experimental | Device: taVNS 100 Hz | Participants receive active transcutaneous auricular vagus nerve stimulation at 100 Hz during one study session. |
Sex: All, ages: 18 Years to 40 Years, accepts healthy volunteers
Inclusion Criteria: * 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 * Willing and able to attend all study visits Exclusion Criteria: * 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 * Active smoking on the assessment day * Pregnancy or suspected pregnancy * Severe discomfort during stimulation (VAS >= 7), dizziness, nausea, or unwillingness to continue * Any condition judged by the investigators to make participation unsuitable'
| Facility | City | Country | Status |
|---|---|---|---|
| Artvin Coruh University, Artvin Vocational School, Disabled Care and Rehabilitation Laboratory | Artvin | Turkey (Türkiye) |