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

NCT07548723 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Autonomic Nervous System (ANS) Functioning and Mood State
  • Heart Rate Variability (HRV)
  • Blood Pressure Monitoring
  • Transcutaneous Electric Nerve Stimulation
  • Photoplethysmography

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.

Sponsors & Collaborators

  • SEFA HAKTAN HATIK

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2026-04-20
Completion
2026-05-05

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07548723 on ClinicalTrials.gov