To evaluate the efficacy of Vagus Nerve Stimulation (VNS) in reducing tinnitus-related distress: A Randomised Control Trial.

Tinnitus is a common auditory symptom that can significantly affect the quality of life and psychological well-being of individuals. Current management strategies often provide limited relief, and there is a need to explore neuromodulation-based interventions like vagus nerve stimulation, which has shown promising results for individuals with tinnitus. This study aims to evaluate the efficacy of transcutaneous vagus nerve stimulation in reducing tinnitus-related distress and severity. This is a single-blinded randomized control trial where three interventions will be given with a total sample size of 150 participants diagnosed with chronic subjective tinnitus. Participants will be randomly allocated into three groups in a one-to-one-to-one ratio. Group A will receive transcutaneous vagus nerve stimulation along with sound therapy and tinnitus educational counselling. Group B will receive transcutaneous vagus nerve stimulation with tinnitus educational counselling. Group C will receive sham stimulation with tinnitus educational counselling, where tinnitus educational counselling is the standard care of treatment. Randomization will be performed using block randomization, and allocation will be concealed. The intervention will be administered over a defined treatment period as per the study protocol. Outcome measures will include the tinnitus functional index and tinnitus-related distress assessed using validated questionnaires at baseline and post-intervention at the 3-month follow-up. Along with questionnaires, auditory evoked potentials will be recorded at baseline and post intervention to see any changes that occurred after VNS. The findings of this study are expected to provide evidence regarding the effectiveness of transcutaneous vagus nerve stimulation with and without sound therapy in the management of tinnitus and may help guide future clinical practice.