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

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

Treatments tested in this trial

  • True Foot Reflexology
  • Sham Foot Reflexology
  • True ta-VNS
  • Sham ta-VNS
  • True Auricular Acupressure
  • Sham Auricular Acupressure
  • Usual Care

Treatment groups

180 Participants
are divided into 5 treatment groups

Sponsors and collaborators