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

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Summary

This study evaluates the reliability and agreement of autonomic nervous system measurements collected from different anatomical sites—chest (reference), finger, and arm—during transcutaneous auricular vagus nerve stimulation (taVNS) in healthy volunteers aged 18–40 years. Data collection occurs across three standardized periods: T0 (5-minute resting baseline), T1 (10 minutes during taVNS), and T2 (5-minute recovery), with heart rate variability, blood pressure, and pulse recorded at each site. The primary objective is to determine how closely finger- and arm-based measurements match the chest reference and how consistent these measurements are across study periods. Participation is voluntary with minimal expected risks including temporary tingling or mild ear discomfort.

“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.”

NIH , verbatim from source
Why this matters

Institutions and investigators designing multi-site HRV measurement protocols for taVNS research may find this trial's methodology informative for their own site-selection decisions and reference-standard calibration procedures.

AI-drafted from the source document, validated against GovPing's analyst note standards . For the primary regulatory language, read the source document .
Published by NIH on changeflow.com . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

This ClinicalTrials.gov registration records a new observational study (NCT07548723) designed to assess measurement reliability for autonomic nervous system parameters during taVNS. The study protocol specifies data collection at three standardized time points using three anatomical measurement sites, with chest as the reference. Researchers studying taVNS or autonomic function should note that this trial focuses on measurement methodology rather than clinical efficacy endpoints.

For clinical investigators and research institutions conducting taVNS studies, this trial provides methodological reference points for site selection and measurement protocol design. The emphasis on inter-site agreement and within-period consistency addresses a practical validity question for multi-site HRV research protocols.

Archived snapshot

Apr 24, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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

N/A NCT07548723 Kind: NA Apr 23, 2026

Abstract

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: Transcutaneous auricular vagus nerve stimulation

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Last updated

Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Autonomic measurement research Clinical trial registration
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Public Health Medical Devices

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