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

NCT07526402 | Not Yet Recruiting

• 1 other identifier: TAVNS4
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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.

  Immediately before and immediately after each 10-minute intervention session

• 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.

  Immediately before and immediately after each 10-minute intervention session

Secondary Outcomes (8)

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

  Immediately before and immediately after each 10-minute intervention session

• Change in Low-Frequency (LF) Power

  Immediately before and immediately after each 10-minute intervention session

• Change in LF/HF Ratio

  Immediately before and immediately after each 10-minute intervention session

• Change in Systolic Blood Pressure

  Immediately before and immediately after each 10-minute intervention session

• Change in Diastolic Blood Pressure

  Immediately before and immediately after each 10-minute intervention session

Study Arms (5)

Sham taVNS

SHAM COMPARATOR

Participants receive sham stimulation during one study session.

Device: Sham taVNS

taVNS 10 Hz

EXPERIMENTAL

Participants receive active transcutaneous auricular vagus nerve stimulation at 10 Hz during one study session.

Device: taVNS 10 Hz

taVNS 25 Hz

EXPERIMENTAL

Participants receive active transcutaneous auricular vagus nerve stimulation at 25 Hz during one study session.

Device: taVNS 25 Hz

taVNS 50 Hz

EXPERIMENTAL

Participants receive active transcutaneous auricular vagus nerve stimulation at 50 Hz during one study session.

Device: taVNS 50 Hz

taVNS 100 Hz

EXPERIMENTAL

Participants receive active transcutaneous auricular vagus nerve stimulation at 100 Hz during one study session.

Device: taVNS 100 Hz

Interventions

Sham taVNS DEVICE

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

Sham taVNS

taVNS 10 Hz DEVICE

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

taVNS 10 Hz

taVNS 50 Hz DEVICE

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

taVNS 50 Hz

taVNS 100 Hz DEVICE

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

taVNS 100 Hz

taVNS 25 Hz DEVICE

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

taVNS 25 Hz

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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'

Sponsors & Collaborators

• Sinop University: lead

Study Sites (1)

Artvin Coruh University, Artvin Vocational School, Disabled Care and Rehabilitation Laboratory

Artvin, Turkey (Türkiye)

Location

Related Publications (4)

• Shaffer F, Ginsberg JP. An overview of heart rate variability metrics and norms. Frontiers in Public Health. 2017;5:258. doi:10.3389/fpubh.2017.00258

  BACKGROUND

• Yakunina N, Kim SS, Nam EC. Optimization of transcutaneous vagus nerve stimulation using functional MRI. Neuromodulation. 2017;20(3):290-300. doi:10.1111/ner.12541

  BACKGROUND

• Peuker ET, Filler TJ. The nerve supply of the human auricle. Clinical Anatomy. 2002;15(1):35-37. doi:10.1002/ca.1089

  BACKGROUND

• Frangos E, Ellrich J, Komisaruk BR. Non-invasive access to the vagus nerve central projections via electrical stimulation of the external ear. Brain Stimulation. 2015;8(3):624-636. doi:10.1016/j.brs.2014.11.018

  BACKGROUND

Central Study Contacts

Sefa Haktan Hatık, MSc, PhD

CONTACT

90 368 271 55 28; haktanhtk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to whether the intervention session involves active taVNS or sham stimulation. The care provider/investigator cannot be blinded because of the technical requirements of device application and condition setup.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Each participant will receive all five intervention conditions (sham, 10 Hz, 25 Hz, 50 Hz, and 100 Hz taVNS) in randomized order across separate visits, with a 48- to 72-hour washout period between sessions.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)