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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
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.
Mayo Clinic in Florida
Jacksonville, Florida, United States
RECRUITINGChange in Dizziness Handicap Inventory (DHI) score
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).
Time frame: Baseline, 4 weeks
Change in Anxiety (HADS-A)
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.
Time frame: Baseline, 4 weeks and 8 weeks
Change in Postural Sway
Postural sway will be measured using Computerized Dynamic Posturography. A ≥10-15% reduction will be considered a meaningful improvement.
Time frame: Baseline, 4 weeks and 8 weeks
Weekly averages of dizzy-day frequency
Frequency of dizzy days will be tracked via patient treatment diary
Time frame: Through end of study, approximately 8 weeks
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