Vagus Auricular Stimulation for Tinnitus

(VAST Trial)

This trial tests a new treatment for individuals with bothersome tinnitus, a ringing or buzzing noise in the ears without an external source. Participants will be randomly assigned to use either an active auricular stimulation device (Vagus Auricular Stimulation) or a sham device. Both groups will also participate in mindfulness-based stress reduction sessions to help reduce the impact of tinnitus and improve well-being. This trial suits English-speaking adults who have experienced moderate to severe tinnitus and are available for the entire study period. As an unphased trial, it offers participants the opportunity to contribute to innovative research that may lead to new treatment options for tinnitus.

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently on active treatment for tinnitus, you would not be eligible to participate.

Research has shown that vagus nerve stimulation in the ear, a treatment under study for tinnitus, is generally safe. Studies have found that this stimulation typically causes only mild and short-lived side effects, such as slight tingling or discomfort at the device's placement site.

Researchers are excited about vagus auricular stimulation for tinnitus because it offers a novel approach compared to traditional treatments like sound therapy, cognitive behavioral therapy (CBT), and medication. Unlike these options, which mainly focus on masking the noise or altering the brain's perception of it, this new method directly targets the nervous system by stimulating the vagus nerve through the ear. This could potentially reset the brain's auditory pathways and reduce the perception of tinnitus. Additionally, when combined with Mindfulness-Based Stress Reduction (MBSR), it may enhance the overall effectiveness by promoting acceptance and reducing stress, which is often linked to tinnitus severity.

This trial will compare two approaches for managing tinnitus symptoms. One group will receive vibrational stimulation of the vagus nerve in the ear combined with Mindfulness-Based Stress Reduction (MBSR). Studies have shown that stimulating the vagus nerve can help reduce tinnitus symptoms. Specifically, research indicates that combining this nerve stimulation with sound therapy improved symptoms in 40% of participants, with effects lasting at least two months. Another group will receive a sham device alongside MBSR. While the treatment doesn't completely eliminate tinnitus, it can make the symptoms more manageable for many people. Overall, evidence suggests this technique could be promising for those dealing with bothersome tinnitus.³⁶⁷⁸⁹