Foot reflexology or ta-VNS for tinnitus in adults
Official title: Efficacy of Foot Reflexology and Transcutaneous Auricular Vagus Nerve Stimulation on Tinnitus in Non-Cancer Adult Populations
Run by Tzu Chi University · NCT07711639 · Data updated 2026-11-12
This trial tests whether foot reflexology, left-ear vagus nerve stimulation, or auricular acupressure can help reduce tinnitus symptoms in adults with tinnitus.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Tzu Chi University Academic / other |
| Locations | 1 site (Hualien City) |
| Status | Recruiting |
| Started | April 28, 2026 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT07711639 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-75 with tinnitus as the sole chief complaint and normal audiometric thresholds.
✕Probably not a fit
Patients with objective tinnitus, certain ear or systemic conditions, or contraindications to the interventions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, single-blind, sham-controlled study compares three approaches—foot reflexology, transcutaneous auricular vagus nerve stimulation (ta-VNS), and auricular acupressure—against usual care in adults with tinnitus. Participants are assigned to true or sham subgroups for the reflexology and ta-VNS arms and are followed at baseline, week 2, week 4, and week 8 to measure changes in tinnitus severity, psychological distress, sleep quality, and autonomic indicators. The trial uses a parallel design with repeated measurements and analyzes data using generalized estimating equations. The setting is Hualien Tzu Chi Hospital, with non-cancer adults who have tinnitus as their sole chief complaint and normal hearing thresholds. Outcomes will help determine if these non-pharmacologic interventions can provide meaningful relief for tinnitus-related symptoms.
Why it matters
Potential benefit: If successful, participants could experience reduced tinnitus severity and improved sleep and mood, potentially offering non-drug options for management.
How similar studies have gone: Previous work with ta-VNS and complementary therapies has shown variable benefits; this trial explores a rigorous sham-controlled design to establish value in tinnitus management.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Hualien Tzu Chi Hospital, Department of Otorhinolaryngology
Hualien City, Taiwan Recruiting
Study contacts
- Study coordinator: Yu-Fu Chou MD
- Email: yufuchou@yahoo.com.tw
- Phone: 886-3-8561825
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.