A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In Chronic Dizziness

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT07420803
Status
Recruiting

Conditions

  • Chronic Dizziness
  • Persistent Postural Perceptual Dizziness

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Mar 23, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224
Colton Clayton, Au.D., Ph.D.
Colton Clayton, Au.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

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