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.

Conditions

• Tinnitus

Interventions

PROCEDURE

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).

PROCEDURE

Sham Foot Reflexology

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

DEVICE

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.

DEVICE

Sham ta-VNS

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

PROCEDURE

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.

PROCEDURE

Sham Auricular Acupressure

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

OTHER

Usual Care

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

Sponsors & Collaborators

• Tzu Chi University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-28

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• Taiwan

Study Locations