tVNS and Myofascial Release in Tinnitus

Summary

This randomized controlled trial aims to investigate the effectiveness of transcutaneous vagus nerve stimulation (tVNS) and myofascial release exercises in patient wiht chronic subjective tinnitus. Participants will be randomly assigned into three groups: (1) tVNS group, (2) Myofascial exercise group, and (3) Control group receiving standart medical care. The primary outcome is change in tinnitus severity measured by the Tinnitus Handicap Inventory (THI). Secondary outcomes include tinnitus loudness Visual Analouge Scale for Tinnitus (VAS), sleep quality Pitsburgh Sleep Quality Index (PSQI) and audiometric findings.

Conditions

• Chronic Tinnitus
• Subjective Tinnitus
• Neuromodulation

Interventions

DEVICE

Transcutaneous Vagus Nerve Stimulation

Participants receive 10 sessions of transcutaneous vagus nerve stimulation over 3 weeks using a TENS device. stimulation is applied to the auricular branch of the vagus nerve (cymba conchae/tragus) for 30 minutes per session. Participants continue usual medical care. Parameters (frequency, pulse width, intencity) are standartized according to safety guidelines. This intervention specifically targets the auricular branch of the vagus nerve, distinguishing it from other device-based intervention such as conventional TENS for pain management or non-auricular vagus stimulation used in other studies.

BEHAVIORAL

Myofascial Release Exercises

Participants receive 10 supervised session over 3 weeks focusing on myofascial release of cervical muscles. in addition to their usual medical management for tinnitus. Exercises are designed to reduse muscle tensionpotentially contributing to tinnitus. This intervention is distinct from general physical therapy or standart relaxation exercises beacause it specifically targets myofascial structures implicated in tinnitus pathophysiology.

OTHER

Standard medical treatment

Participants continue their usual medical management for tinnitus without additional interventions. This group serves as a control to compare the effects of tVNS and myofascial exercises. It differs from sham or placebo interventions used in oter studies because no active or stimalated treatment is provided.

Sponsors & Collaborators

• Necmettin Erbakan University

  lead OTHER

Principal Investigators

• Neslihan ALTUNTAŞ YILMAZ, PhD · Necmettin Erbakan University Nezahat Kelesoglu Faculty of Health Sciences

• Mehmet Akif DUNDAR, PhD · Necmettin Erbakan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-17

Primary Completion

2025-09-25

Completion

2025-10-10

Countries

• Turkey (Türkiye)

Study Locations