FR-taVNS Tinnitus Tria

ConditionTinnitus

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorTzu Chi University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

True Foot Reflexology
Procedure/Surgery
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
Procedure/Surgery
Light touch on non-specific foot areas (dorsum, anterior ankle, foot margins) without effective pressure.
True ta-VNS
Device
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
Device
Left earlobe, 0.5 mA, otherwise identical parameters (250 µs, 25 Hz, 30 s on/off).
True Auricular Acupressure
Procedure/Surgery
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
Procedure/Surgery
Beads at left earlobe (non-vagal regions), same frequency/duration.
Usual Care
Other intervention
Standard tinnitus clinical care (pharmacologic and supportive); no study intervention.

Treatment groups

180 Participants

are divided into 5 treatment groups

Group A: Arm A: Foot Reflexology - True (n=36)Experimental treatment 1 intervention

Group B: Arm B: Foot Reflexology - Sham (n=36)Sham comparator 1 intervention

Group C: Arm C: ta-VNS - True (n=36)Experimental treatment 2 interventions

Group D: Arm D: ta-VNS - Sham (n=36)Sham comparator 2 interventions

Group E: Arm E: Usual Care (n=36)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Tinnitus Handicap Inventory (THI) score

25-item scale across functional, emotional, and catastrophic subscales; total 0-100, higher = greater handicap.

Time frame