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 range

18 Years – 40 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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