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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.
Official title: Efficacy of Foot Reflexology and Transcutaneous Auricular Vagus Nerve Stimulation on Tinnitus in Non-Cancer Adult Populations
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-04-28
Completion Date
2028-12-31
Last Updated
2026-07-24
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Hualien Tzu Chi Hospital, Department of Otorhinolaryngology
Hualien City, Taiwan