Skip to main content
OpenTrials
Completed

NCT Number: NCT06614933

How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?

The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami, Plumer Building

Coral Gables, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • between the ages of 18-80 years
  • English speaking (must be able to consent and complete the interviews in English)

Exclusion criteria

  • chronic pain (average intensity >2/10 on 0-10 scale, for longer than 3 months)
  • acute pain of intensity greater than 3/10
  • chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease)
  • any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
  • pregnancy
  • currently taking Buprenorphine or recently stopped taking (within 1 month)
  • presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
  • implants in the head or neck, cochlear implants, or pacemaker
  • head or neck metastasis or recent ear trauma
  • history of epilepsy
  • history of autonomic nervous system dysfunction (e.g., postural orthostatic tachycardia syndrome).

Treatment and study plan

Biphasic transcutaneous auricular vagus nerve stimulation

Device

Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a biphasic current, continuous at 25 Hz, for 1 hour, in-person.

Monophasic transcutaneous auricular vagus nerve stimulation

Device

Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a monophasic current, with a 50% duty cycle at 25 Hz, for 1-hour, in-person.

Primary outcomes

  1. Tolerability Measured by Tolerability Questionnaire

    Time frame: Up to 3 hours

    Tolerability will be assessed with a questionnaire with scores ranging from 0 (no discomfort) to 10 (worst pain imaginable) for comfort.

  2. Tolerability Measured by Self Report

    Time frame: Up to 3 hours

    Tolerability will be assessed by self-report using semi-structured interviews conducted at the end of each study visit. Participants will report whether they experienced mild pain during each transcutaneous auricular vagus nerve stimulation (taVNS) protocol. The outcome measure is the count of participants who reported mild pain, as collected during interviews conducted at the end of each visit.

Secondary outcomes

  1. Change in Heart Rate Variability (HRV)

    Time frame: Baseline and up to 3 hours

    Heart rate variability (HRV) will be measured using an H10 chest strap device and expressed in milliseconds. Values after stimulation will be subtracted from baseline values; thus, a positive number will indicate an increase in HRV post taVNS.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.