An interventional study of True Foot Reflexology and Sham Foot Reflexology in Tinnitus, sponsored by Tzu Chi University. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Tzu Chi University · Not applicable, Interventional, and Treatment
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.
This is a three-arm parallel, repeated-measures randomized controlled trial conducted in the otolaryngology outpatient and inpatient settings of Hualien Tzu Chi Hospital. Eligible non-cancer adults with tinnitus as the sole chief complaint and normal pure-tone thresholds are stratified by age and sex, then randomized by computer-generated random number tables to the FR group, the ta-VNS group, or the usual-care control group; the FR and ta-VNS groups are further randomized to true or sham subgroups. The foot reflexology intervention is delivered once weekly for 20 minutes over four sessions (one month) and comprises a relaxation phase, an inner-ear/autonomic regulation phase, and a circulation/detoxification phase; the sham condition applies light, non-specific touch. The ta-VNS intervention stimulates the left tragus, cymba conchae, and cavum conchae (pulse width 250 µs, 25 Hz, 0.5-5 mA individualized to a tingling sensation, 30 s on/off) once weekly for 20 minutes over four weeks; the sham condition stimulates the left earlobe at 0.5 mA. Auricular acupressure with magnetic beads is self-administered three times daily. Outcomes are assessed at T0 (baseline), T1 (week 2), T2 (week 4), and T3 (week 8). Data are analyzed with generalized estimating equation (GEE) models.
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's planned enrollment of 180 is above the median of 60 across 368 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →Tzu Chi University is the lead sponsor of 20 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: True Foot Reflexology
Procedure: True Foot Reflexology
Procedure: Sham Foot Reflexology
Procedure: Sham Foot Reflexology
Device: True ta-VNS + Procedure: Auricular Acupressure
Device: True ta-VNS · Procedure: True Auricular Acupressure
Device: Sham ta-VNS + Procedure: Sham Auricular Acupressure
Device: Sham ta-VNS · Procedure: Sham Auricular Acupressure
Other: Usual Care
Other: Usual Care
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).
Light touch on non-specific foot areas (dorsum, anterior ankle, foot margins) without effective pressure.
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.
Left earlobe, 0.5 mA, otherwise identical parameters (250 µs, 25 Hz, 30 s on/off).
Magnetic beads (1-2 mm) at left tragus, cymba conchae, cavum conchae; pressed 3×/day, \~30 s per point; changed every 2-3 days.
Beads at left earlobe (non-vagal regions), same frequency/duration.
Standard tinnitus clinical care (pharmacologic and supportive); no study intervention.
Change in Tinnitus Handicap Inventory (THI) score
25-item scale across functional, emotional, and catastrophic subscales; total 0-100, higher = greater handicap.
Time frame: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Change in Tinnitus Functional Index (TFI) score
25-item scale; total 0-100, higher = greater impact.
Time frame: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Change in Distress Thermometer (DT)
0-10 single-item rating; \>=4 indicates clinically significant distress.
Time frame: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Change in Pittsburgh Sleep Quality Index (PSQI)
19-item; total 0-21, \>5 indicates poor sleep.
Time frame: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Change in Heart Rate Variability (HRV)
TS-0411 wrist device (HRV Master, TFDA license no. 001525), after 10-min rest, \~5-min wrist recording.
Time frame: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Change in salivary cortisol concentration
1 cc saliva, ELISA.
Time frame: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Dec 2028, 32 months after the start.
Of 133 non-industry interventional studies with no phase under Tinnitus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 32 months is above that.
Counting every sponsor, half of 151 studies reached it within 17 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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