tVNS and Myofascial Release in Tinnitus

NCT07155733 | Active Not Recruiting

• 1 other identifier: 23069
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tinnitus; chronic tinnitus; subjective tinnitus; vagus nerve stimulation; Transcutaneous Vagus Nerve Stimulation (tVNS); Auricular Vagus Nerve Stimulation; Neuromodulation; Myofascial Release; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Change in tinnitus severity

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

  Baseline to post-intervention (3 weeks)

Secondary Outcomes (3)

• Tinnitus Loudness

  Baseline to post-intervention (3 weeks)

• Sleep quality

  Baseline to post-intervention (3 weeks)

• Audiometric measures

  Baseline to post-intervention (3 weeks)

Study Arms (3)

Transcutaneous Vagus Nerve Stimulation

EXPERIMENTAL

10 sessions over 3 weeks; auricular stimulation of the vagus nerve using TENS; session duration 30 min.

Device: Transcutaneous Vagus Nerve Stimulation; Other: Standard medical treatment

Myofascial Exercise Group

EXPERIMENTAL

10 supervised sessions over 3 weeks; targeting cervical muscles.

Behavioral: Myofascial Release Exercises; Other: Standard medical treatment

Control Group

NO INTERVENTION

Standart Medical Care without additional inerventions

Interventions

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.

Transcutaneous Vagus Nerve Stimulation

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.

Myofascial Exercise Group

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.

Myofascial Exercise Group; Transcutaneous Vagus Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University Meram Faculty of Medicine

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Publications (2)

• Rocha CB, Sanchez TG. Efficacy of myofascial trigger point deactivation for tinnitus control. Braz J Otorhinolaryngol. 2012 Dec;78(6):21-6. doi: 10.5935/1808-8694.20120028.

  PMID: 23306563 BACKGROUND

• Yakunina N, Nam EC. Direct and Transcutaneous Vagus Nerve Stimulation for Treatment of Tinnitus: A Scoping Review. Front Neurosci. 2021 May 28;15:680590. doi: 10.3389/fnins.2021.680590. eCollection 2021.

  PMID: 34122002 BACKGROUND

Related Links

• This webpage provides information about Dr. Neslihan Altuntaş Yılmaz, a faculty member at the Department of Physiotherapy and Rehabilitation, Necmettin Erbakan University. Researchers interested in accessing individual participant data (IPD) from this cl

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Neslihan ALTUNTAŞ YILMAZ, PhD

  Necmettin Erbakan University Nezahat Kelesoglu Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

• Mehmet Akif DUNDAR, PhD

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Both participants and treating clinicians are not blinded due to the nature of the interventions. Outcome assesor who scoring THI, recording VAS, PSQI is not blinded, those who scores audiometric outcomes are blinded to group assignment to reduce assesment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bsc

Model Details: This is a three-arm, parallel group randomized controlled trial comparing the effects of transcutaneous vagus nerve stimulation (tVNS), myofascial release exercise, and standart medical care on chronic subjective tinnitus. Participants are randomly assigned to one of three groups and receive their assigned intervanetion to evaluate changes in tinnitus severity, sleep quality and audiometric measures.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: April 17, 2025
• Primary Completion: September 25, 2025
• Study Completion: October 10, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months after study completion-5 years after completion
• Access Criteria: Data available upon request to qualified researchers for scientific purposes. Requests should be sent to the Principal Investigator via the contact page below. Data will be shared after signing a data use agreement.

Locations

TU (1)