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NCT Number: NCT07155733

tVNS and Myofascial Release in Tinnitus

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Neuromodulation Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Subjective Tinnitus Tinnitus

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University Meram Faculty of Medicine

Konya, Meram, 42090, Turkey (Türkiye)

About this study

Tinnitus is a common and distressing condition that significantly impairs quality of life. Recent studies suggest that neuromdulation techniques such as vagus nerve stimulation and physical interventions targeting myofascial structures may reduce tinnitus severity. However, evidence remains limited, and comparative effectiveness of these approaches is not well established.

This single-center randomized controlled trial will compare the effects of transcutaneous vagus nerve stimulation (tVNS) and myofascial release exercises with a control group receiving only medical treatment. A total of 45 participants with chronic subjective tinnitus will be recruited. Participants will be randomized into three groups and receive 10 intervention sessions over three weeks.

The tVNS group will receive transcutaneous stimulation of the auricular branch of the vagus nerve using a TENS (Everyway N604, Taiwan) device. The myofascial group will undergo guided myofascial release targeting cervical muscles in addition to medical treatment. The control group will continue their medical treatment without additional interventions.

The primary outcome measure will be change in tinnitus-related handicap using the Tinnitus Handicap Inventory (THI). Secondary outcomes will include tinnitus loudness assesed by a Visual Analogue Scale for Tinnitus (VAS), sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) and audiometric assesments.

The findings from this trial may provide new insights into non-farmacological rehabiliation strategies for tinnitus and clarify the role of neuromodulation compared with physical therapy inreventions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of chronic subjective tinnitus (>6 months)
  • Ability to understand and provide written informed consent
  • Willingness to comply with study procedures and intervention schedule
  • Resistant for medical treatment for subjective tinnitus
  • Impacted daily living by tinnitus

Exclusion criteria

  • Diagnoses such as auditory hallucinations, Meniere's disease, vestibular tumor, vertigo, or sudden hearing loss
  • Trauma or surgical interventions involving the neck, jaw, or head within the 6 months
  • Epilepsy or presence of a cardiac pacemaker (contraindication for tVNS)
  • History of acute psychiatric disorders
  • Use of ototoxic medications
  • Physical limitations that prevent participation in exercise interventions.

Treatment and study plan

Transcutaneous vagus nerve stimulation

Device

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.

Myofascial Release Exercises

Behavioral

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.

Standard Medical Treatment

Other

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.

Primary outcomes

  1. Change in tinnitus severity

    Time frame: Baseline to post-intervention (3 weeks)

    Measured using the Tinnitus Handicap Inventory (THI), which assesses the impact of tinnitus on daily functioning.

Secondary outcomes

  1. Tinnitus Loudness

    Time frame: Baseline to post-intervention (3 weeks)

    Assessed using Visual Analogue Scale for Tinnitus (VAS)

  2. Sleep quality

    Time frame: Baseline to post-intervention (3 weeks)

    Measured using the Pittsburgh Sleep Quality Index (PSQI).

  3. Audiometric measures

    Time frame: Baseline to post-intervention (3 weeks)

    Pure-tone audiometry to assess hearing tresholds across frequencies

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

Comparison Of The Effectiveness Of Myofascial Release Exercises and Vagus Nerve Neuromodulation in Tinnitus Patients: Randomized Controlled Trial

Acronym: TVNS-TINN

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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