FR-taVNS Tinnitus Tria

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

Inclusion Criteria:

* Age 18-75 years, conscious, able to communicate and comprehend, and able to complete questionnaires and comply with study procedures
* Tinnitus as the sole chief complaint, with pure-tone thresholds ≤25 dB HL bilaterally at 500, 1000, 2000, and 4000 Hz

Exclusion Criteria:

* Objective tinnitus, peripheral vestibular disease, central nervous or cardiovascular causes, or other organic ear pathology
* Open wounds or skin lesions of the foot or ear, lower-limb edema, history of deep vein thrombosis, or diabetes with most recent HbA1c \>7.5%
* Cardiac pacemaker or other implanted electronic device, or other severe cardiovascular disease
* Foot reflexology or vagus nerve stimulation within the past 3 months
* Pregnant or breastfeeding women
* History of epilepsy or seizures
* Physically frail condition

Conditions3

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