Recruiting

aTVNS

Sponsor:

Mayo Clinic

Code:

NCT07420803

Conditions

Chronic Dizziness

Persistent Postural Perceptual Dizziness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sham Device

Auricular transcutaneous vagus nerve stimulation

Study Details

Brief summary:

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).

Conditions

Chronic Dizziness

Persistent Postural Perceptual Dizziness

Study ID

NCT07420803

Start date

Mar 23, 2026

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Change in Dizziness Handicap Inventory (DHI) score [ Time Frame: Baseline, 4 weeks ]

Central Contacts and Locations

Central contacts

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

904-953-2945clayton.colton@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Principal Investigator:

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

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 17, 2026

Last verified

Feb, 2026

Keywords

  • Vagus Nerve Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-17.