tVNS and Myofascial Release in Tinnitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-17

Study Completion Date

2025-10-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Tinnitus Subjective Tinnitus Neuromodulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Transcutaneous Vagus Nerve Stimulation

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

Group Type EXPERIMENTAL

Transcutaneous Vagus Nerve Stimulation

Intervention Type 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.

Standard medical treatment

Intervention Type 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

10 supervised sessions over 3 weeks; targeting cervical muscles.

Group Type EXPERIMENTAL

Myofascial Release Exercises

Intervention Type 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

Intervention Type 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.

Control Group

Standart Medical Care without additional inerventions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No