tVNS and Myofascial Release in Tinnitus

Not Applicable

Active, not recruiting

• Conditions: Chronic Tinnitus; Subjective Tinnitus; Neuromodulation

• Registration Number: NCT07155733
• Lead Sponsor: Necmettin Erbakan University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2025-04-17
• Status Verified: 2025-08
• Study First Submitted: 2025-08-27
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2025-09-25
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in tinnitus severity	Baseline to post-intervention (3 weeks)	Measured using the Tinnitus Handicap Inventory (THI), which assesses the impact of tinnitus on daily functioning.

Secondary Outcome Measures

Name	Time	Method
Tinnitus Loudness	Baseline to post-intervention (3 weeks)	Assessed using Visual Analogue Scale for Tinnitus (VAS)
Sleep quality	Baseline to post-intervention (3 weeks)	Measured using the Pittsburgh Sleep Quality Index (PSQI).
Audiometric measures	Baseline to post-intervention (3 weeks)	Pure-tone audiometry to assess hearing tresholds across frequencies

Trial Locations

Locations (1)

Necmettin Erbakan University Meram Faculty of Medicine; Konya, Meram, Turkey (Türkiye)