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Completed

NCT Number: NCT06381102

Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1

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.

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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

Miami, Florida, 33136, 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

transcutaneous auricular vagus nerve stimulation 30/30

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 30 second on and 30 second off, for 1 hour, in-person.

transcutaneous auricular vagus nerve stimulation 10/10

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 10 second on and 10 second off, for 1 hour, in-person.

Primary outcomes

  1. Tolerability Measured by Tolerability Questionnaire

    Time frame: 3 hours

    Tolerability will be assessed with a questionnaire with scores ranging from 0 -10 (with 0 being no irritation or discomfort and 10 being the worst possible irritation or discomfort) for irritation from tingling/tickling/pricking during taVNS.

  2. Tolerability Measured by Self-report

    Time frame: 3 hours

    The number of participants who reported mild pain with the intervention.

Secondary outcomes

  1. Change in Heart Rate Variability (HRV)

    Time frame: Baseline and 3 hours

    HRV will be measured with an H10 chest strap device. Values after stimulation will be subtracted from baseline values; thus, a positive number will indicate an increase in HRV post taVNS measured in milliseconds.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

How Does the Length of Pulse Trains and Pulse Intervals Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2024
Registry last updated
Aug 24, 2025

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.

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