By InvitationNot Applicable

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

Turkey (Türkiye)1 participantsStarted 2023-03-20

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 to 40 years. * Healthy volunteers without known chronic disease or acute illness at the time of participation. * Able and willing to comply with study procedures and instructions. * Provided written informed consent. Exclusion Criteria: * Any cardiovascular disease, arrhythmia, hypertension, or similar condition. Any neurological disorder (e.g., diabetes mellitus, peripheral neuropathy, epilepsy). * Any diagnosed psychiatric disorder. * Pregnancy or suspected pregnancy. * Ear conditions that prevent stimulation (infection, open wound, pain/tenderness) or the presence of a piercing at/near the stimulation site. * Vigorous exercise within 24 hours prior to the measurement. * Caffeine intake, smoking, or alcohol consumption within 4-6 hours prior to the measurement. * Marked intolerance or hypersensitivity to the devices or the procedure. * Inability to follow instructions during measurements or refusal to complete the session.

What they're measuring

RMSSD inter-site agreement across chest, finger, and arm recordings

Timeframe: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).

SDNN inter-site agreement across chest, finger, and arm recordings

Timeframe: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).

LF power inter-site agreement across chest, finger, and arm recordings

Timeframe: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).

HF power inter-site agreement across chest, finger, and arm recordings

Timeframe: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).

LF/HF ratio inter-site agreement across chest, finger, and arm recordings

Timeframe: During a single session: baseline (T0, 5 minutes), stimulation (T1, 10 minutes), and recovery (T2, 5 minutes).

Trial details

NCT IDNCT07548723

SponsorSEFA HAKTAN HATIK

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-20

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