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Clinical Trials in Turkey / NCT07155733
Active, not recruiting Not applicable

tVNS and Myofascial Release in Tinnitus

NCT07155733 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-04-17
Last updated
2025-09-04

Condition(s) studied

Chronic TinnitusSubjective TinnitusNeuromodulation

Investigational drug(s) / intervention(s)

Transcutaneous Vagus Nerve StimulationMyofascial Release ExercisesStandard medical treatment

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.

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Necmettin Erbakan University Meram Faculty of Medicine Konya Meram

More Necmettin Erbakan University trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07155733 on ClinicalTrials.gov ↗ ← All trials in Turkey