Tinnitus Clinical Trials

Find Tinnitus Clinical Trials Near You

Efficacy of Foot Reflexology and Transcutaneous Auricular Vagus Nerve Stimulation on Tinnitus in Non-Cancer Adult Populations

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
Hualien Tzu Chi Hospital, Department of Otorhinolaryngology
RECRUITING
Hualien City
Contact Information
Primary
Yu-Fu Chou MD
yufuchou@yahoo.com.tw
886-3-8561825
Backup
Chun-Hou Huang
hou2017@gms.tcu.edu.tw
Time Frame
Start Date: 2026-04-28
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 180
Treatments
Experimental: Arm A: Foot Reflexology - True (n=36)
Procedure: True Foot Reflexology
Sham_comparator: Arm B: Foot Reflexology - Sham (n=36)
Procedure: Sham Foot Reflexology
Experimental: Arm C: ta-VNS - True (n=36)
Device: True ta-VNS + Procedure: Auricular Acupressure
Sham_comparator: Arm D: ta-VNS - Sham (n=36)
Device: Sham ta-VNS + Procedure: Sham Auricular Acupressure
Active_comparator: Arm E: Usual Care (n=36)
Other: Usual Care
Related Therapeutic Areas
Sponsors
Leads: Tzu Chi University

This content was sourced from clinicaltrials.gov