tVNS and Myofascial Release in Tinnitus (TVNS-TINN)

Necmettin Erbakan University

Status: Active, not recruiting

Conditions: Subjective Tinnitus; Chronic Tinnitus; Neuromodulation

Treatments: Behavioral: Myofascial Release Exercises; Device: Transcutaneous Vagus Nerve Stimulation; Other: Standard medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07155733

23069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Transcutaneous Vagus Nerve Stimulation

Experimental group

Description:

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

Treatment:

Other: Standard medical treatment

Device: Transcutaneous Vagus Nerve Stimulation

Myofascial Exercise Group

Experimental group

Description:

10 supervised sessions over 3 weeks; targeting cervical muscles.

Treatment:

Other: Standard medical treatment

Behavioral: Myofascial Release Exercises

Control Group

No Intervention group

Description:

Standart Medical Care without additional inerventions