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FR-taVNS Tinnitus Tria

RecruitingNAAges 18 Years - 75 YearsAllTzu Chi University
NCT07711639 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • True Foot Reflexology
  • Sham Foot Reflexology
  • True ta-VNS
  • Sham ta-VNS
  • True Auricular Acupressure
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Where

1 site
Hualien Tzu Chi Hospital, Department of Otorhinolaryngology
Hualien City, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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