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ENROLLING BY INVITATION
NCT07548723
NA

taVNS During Multi-site HRV Measurement: Reliability & Agreement Study

Sponsor: SEFA HAKTAN HATIK

View on ClinicalTrials.gov

Summary

This study examines the reliability and agreement of autonomic nervous system measurements obtained from different anatomical sites during transcutaneous auricular vagus nerve stimulation (taVNS). taVNS is a non-invasive electrical stimulation delivered to the ear using a small stimulator. Healthy volunteers aged 18-40 years will participate in one laboratory session. Heart rate and heart rate variability will be recorded from the chest (reference), finger, and arm. Blood pressure and pulse will also be measured. Data will be collected in three standardized periods: T0 (5-minute resting baseline), T1 (10 minutes during taVNS), and T2 (5-minute recovery). The main goal is to determine how closely finger- and arm-based measurements match the chest reference and how consistent these measurements are across the study periods. Participation is voluntary, and participants may withdraw at any time. Expected risks are minimal and may include temporary tingling or mild discomfort at the ear and, rarely, lightheadedness. No direct medical benefit is expected, but the findings may help improve how autonomic responses are monitored during taVNS in future research.

Official title: Assessment of Reliability and Agreement of Autonomic Measures Across Different Anatomical Sites During Transcutaneous Auricular Vagus Nerve Stimulation

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

1

Start Date

2023-03-20

Completion Date

2026-05-05

Last Updated

2026-04-23

Healthy Volunteers

Yes

Interventions

DEVICE

Transcutaneous auricular vagus nerve stimulation

Transcutaneous auricular vagus nerve stimulation will be delivered to the cymba conchae region of the auricle using an external stimulator. Stimulation will be set to 25 Hz with a pulse width of 200-300 microseconds. Current intensity will be individually adjusted to a clearly perceptible but non-painful level (typically 0.5-5 mA). Stimulation will be applied for 10 minutes.

Locations (1)

Güzelyurt Neighborhood, Mustafa Bozkurt Street, No: 9, Türkeli, Sinop, Türkiye

Sinop, Turkey (Türkiye)