A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In Chronic Dizziness

April 14, 2026 updated by: Colton T. Clayton, Mayo Clinic

Efficacy Of Auricular Transcutaneous Vagus Nerve Stimulation In Treating Chronic Dizziness

The purpose of this study is to measure the change in dizziness, as measured by change in Dizziness Handicap Inventory (DHI) score, following a 4-week treatment period with auricular transcutaneous vagus nerve stimulation (aTVNS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
          • Colton Clayton, Au.D., Ph.D.
        • Principal Investigator:
          • Colton Clayton, Au.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-75, Persistent Postural-Perceptual Dizziness (PPPD) diagnosis per International Classification of Vestibular Disorders (ICVD).
  • Persistent dizziness ≥3 months and at least 1 dizziness exacerbation/day during 2-week run-in.
  • On stable medications/therapy for ≥4 weeks prior to baseline (if any).

Exclusion Criteria:

  • Uncompensated peripheral/central vestibular deficit, sensory-afferent or cerebellar ataxia.
  • Cardiac disease (coronary disease, unstable arrhythmia), recurrent syncope (>1 in past 12 months).
  • Neck surgery, vagotomy, or any condition interfering with vagal stimulation.
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auricular transcutaneous vagus nerve stimulation
The vagus nerve stimulation group will perform two sessions per day (morning and evening), each lasting approximately 30 minutes, for a total of 1 hour of auricular transcutaneous vagus nerve stimulation. This arm will continue using the active treatment for 8 weeks.
Other: Auricular transcutaneous vagus nerve stimulation

The Parasym AVNT is a noninvasive, transcutaneous auricular vagus nerve stimulator (tVNS) designed to deliver low-level electrical stimulation to the auricular branch of the vagus nerve through the skin of the outer ear.

The stimulator produces mild, pulsed electrical currents typically ranging from 0.1 to 5.0 milliampere (mA) at frequencies between 20-30 Hz and pulse widths of approximately 200-300 μs. The stimulation intensity is adjusted individually to produce a light tingling sensation without discomfort or visible muscle contraction.
Sham Comparator: Sound sham electrodes
The sham control group will will perform two sessions per day (morning and evening), each lasting approximately 30 minutes, for a total of 1 hour of daily stimulation using the sham device. After 4 weeks, the sham control group will begin active auricular transcutaneous vagus nerve stimulation for 4 weeks.
Other: Sham Device
The sham control uses the same stimulation devices as the active group, but with modified electrodes that do not emit electrical current. Instead, they produce a mechanical vibration or clicking sensation that mimics the feeling of stimulation without delivering current to the skin.
Other: Auricular transcutaneous vagus nerve stimulation

The Parasym AVNT is a noninvasive, transcutaneous auricular vagus nerve stimulator (tVNS) designed to deliver low-level electrical stimulation to the auricular branch of the vagus nerve through the skin of the outer ear.

The stimulator produces mild, pulsed electrical currents typically ranging from 0.1 to 5.0 milliampere (mA) at frequencies between 20-30 Hz and pulse widths of approximately 200-300 μs. The stimulation intensity is adjusted individually to produce a light tingling sensation without discomfort or visible muscle contraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Dizziness Handicap Inventory (DHI) score
Time Frame: Baseline, 4 weeks
The Dizziness Handicap Inventory (DHI) is a 25-item questionnaire assesses physical, emotional, and functional aspects of dizziness. Each of the 25 questions has three answers: "Always" (4 points), "Sometimes" (2 points), or "No" (0 points). Scores are summed for a total from 0 (no disability) to 100 (maximum disability).
Baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety (HADS-A)
Time Frame: Baseline, 4 weeks and 8 weeks
The Hospital Anxiety and Depression (HAD) is a self-reported 14 item questionnaire asking participants to reflect on their mood in the past week. . Each item is rated on a 4-point scale, for a total score ranging from 0-21 for each subscale. A higher score indicates higher distress. Clinically meaningful change is defined as a ≥2-3-point reduction.
Baseline, 4 weeks and 8 weeks
Change in Postural Sway
Time Frame: Baseline, 4 weeks and 8 weeks
Postural sway will be measured using Computerized Dynamic Posturography. A ≥10-15% reduction will be considered a meaningful improvement.
Baseline, 4 weeks and 8 weeks
Weekly averages of dizzy-day frequency
Time Frame: Through end of study, approximately 8 weeks
Frequency of dizzy days will be tracked via patient treatment diary
Through end of study, approximately 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Colton Clayton, Au.D., Ph.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 25-012683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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