FR-taVNS Tinnitus Tria

Condition(s) studied

Investigational drug(s) / intervention(s)

True Foot Reflexology: Once weekly, 20 min, 4 sessions over 1 month. Three phases: relaxation (diaphragm, brain, spine reflex zones, 3 min); inner-ear and autonomic regulation (inner ear, hypothalamus, cerebellum, brainstem, thyroid, adrenal zones, 10 min); circulation/detoxification (kidney, lymphatic zones, 7 min).

Sham Foot Reflexology: Light touch on non-specific foot areas (dorsum, anterior ankle, foot margins) without effective pressure.

True ta-VNS: Left tragus, cymba conchae, cavum conchae; 250 µs, 25 Hz, 0.5-5 mA individualized to tingling, 30 s on/off; once weekly, 20 min, 4 weeks. Device: Hong-Tai mid-frequency electrotherapy stimulator, model HT66B (TFDA license no. 000637), used off-label for auricular vagus nerve stimulation.

Sham ta-VNS: Left earlobe, 0.5 mA, otherwise identical parameters (250 µs, 25 Hz, 30 s on/off).

True Auricular Acupressure: Magnetic beads (1-2 mm) at left tragus, cymba conchae, cavum conchae; pressed 3×/day, \~30 s per point; changed every 2-3 days.

Sham Auricular Acupressure: Beads at left earlobe (non-vagal regions), same frequency/duration.

Usual Care: Standard tinnitus clinical care (pharmacologic and supportive); no study intervention.

Study summary

Tinnitus is a common neurosensory symptom affecting 12-30% of adults and is closely associated with anxiety, sleep disturbance, and autonomic dysregulation. Current pharmacologic treatments offer limited efficacy and notable side effects, prompting interest in non-pharmacological approaches. This randomized, single-blind, sham-controlled trial evaluates whether foot reflexology (FR), transcutaneous auricular vagus nerve stimulation (ta-VNS), and auricular acupressure (AA) improve tinnitus severity, psychological distress, sleep quality, and autonomic indicators (heart rate variability and salivary cortisol) in non-cancer adults with tinnitus, compared with usual care. Participants are randomized to a foot reflexology group, an auricular vagus nerve stimulation group (each with true and sham subgroups), or a usual-care control group, and are followed at baseline and weeks 2, 4, and 8.

Eligibility

Primary outcome measure(s)

• Change in Tinnitus Handicap Inventory (THI) score — T0 baseline, T1 week 2, T2 week 4, T3 week 8
  25-item scale across functional, emotional, and catastrophic subscales; total 0-100, higher = greater handicap.
• Change in Tinnitus Functional Index (TFI) score — T0 baseline, T1 week 2, T2 week 4, T3 week 8
  25-item scale; total 0-100, higher = greater impact.

Trial sites (1)

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