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NCT Number: NCT07420803

A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In 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).

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Key information

Conditions

Chronic Dizziness Persistent Postural Perceptual Dizziness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Colton Clayton, Au.D., Ph.D.

CONTACT

Colton Clayton, Au.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Sham Device

Other

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.

Auricular transcutaneous vagus nerve stimulation

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Colton Clayton, Au.D., Ph.D.

CONTACT

[email protected]

904-953-2945

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Efficacy Of Auricular Transcutaneous Vagus Nerve Stimulation In Treating Chronic Dizziness

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Apr 17, 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.

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