Clinical trial · Interventional
FR-taVNS Tinnitus Tria
Efficacy of Foot Reflexology and Transcutaneous Auricular Vagus Nerve Stimulation on Tinnitus in Non-Cancer Adult Populations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tinnitus | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sham Auricular Acupressure | Procedure | — | UNRESOLVED |
| Sham Foot Reflexology | Procedure | — | UNRESOLVED |
| Sham ta-VNS | Device | — | UNRESOLVED |
| True Auricular Acupressure | Procedure | — | UNRESOLVED |
| True Foot Reflexology | Procedure | — | UNRESOLVED |
| True ta-VNS | Device | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Arm A: Foot Reflexology - True (n=36)
- description
- Procedure: True Foot Reflexology
- interventionNames
- Procedure: True Foot Reflexology
- type
- SHAM_COMPARATOR
- label
- Arm B: Foot Reflexology - Sham (n=36)
- description
- Procedure: Sham Foot Reflexology
- interventionNames
- Procedure: Sham Foot Reflexology
- type
- EXPERIMENTAL
- label
- Arm C: ta-VNS - True (n=36)
- description
- Device: True ta-VNS + Procedure: Auricular Acupressure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTStegeman I, Velde HM, Robe PAJT, Stokroos RJ, Smit AL. Tinnitus treatment by vagus nerve stimulation: A systematic review. PLoS One. 2021 Mar 11;16(3):e0247221. doi: 10.1371/journal.pone.0247221. eCollection 2021. PMID 33705401
- RESULTNewman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. doi: 10.1001/archotol.1996.01890140029007. PMID 8630207