Vagus Auricular Stimulation for Tinnitus (VAST)

The Washington University

Status: Active, not recruiting

Conditions: Tinnitus

Treatments: Device: Sham; Device: Vibrational stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06821893

202411118

Details and patient eligibility

About

This pilot study is a randomized, double-blinded controlled trial of adult participants with chronic, moderate to severe bothersome subjective tinnitus. Participants will be randomly assigned to either an active auricular stimulation device group or a sham-control group.Both groups will also undergo virtual Mindfulness-Based Stress Reduction(MBSR) over 8 weeks to promote tinnitus bother reduction, and general well-being. Outcome measures will be assessed at baseline, end of intervention, and at 1-month post-intervention.

Full description

Adults experiencing moderate to severe tinnitus have significant impairment in their quality of life. While Cognitive Behavioral Therapy (CBT) is the most effective treatment for tinnitus, its accessibility is limited. Alternative treatment options such as masking pose significant risks and have varying success rates in achieving tinnitus cessation. Given these limitations and risks, there is a need to explore alternative treatment options for tinnitus that are both effective and easily accessible. Transcutaneous electrical stimulation of the vagus nerve has been explored as a treatment option for tinnitus using different study designs with varying response rate. In contrary, this pilot study will provide valuable insights and preliminary evidence for the effectiveness of transcutaneous stimulation of the auricular branch of the vagus nerve (TABVN-stim) utilizing a novel device that produces vibrational stimulation mimicking physiological sensory input to the ABVN. This research provides preliminary evidence for a potentially safe, non-invasive, and easily applicable treatment option for those suffering from chronic bothersome tinnitus, ultimately improving their quality of life.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18
• Ability to read, write, speak, and understand English
• Bothersome tinnitus with initial TSSF score greater than 40 on screening
• Available for the entire period of the study including one month follow-up after completion of 8-week intervention period
• Access to internet-connected device(s) such as phone, tablet, or laptop with a camera

Exclusion criteria

• Age>70
• Pregnant or planning to become pregnant during the study period
• Previous participation in an auricular stimulation trial
• Currently on active treatment for tinnitus
• Have cochlear implant or other device that impedes usage of auricular stimulation device
• Tinnitus related to ear surgery, Meniere's disease, ear infections, or other ear pathology
• Substance abuse
• Unstable psychiatric disorders
• Patient Health Questionnaire (PHQ-9) score greater than 9 History of brain surgery
• History of traumatic brain injury
• History of bradycardia or bradyarythmias

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Vibrational stimulation + MBSR

Experimental group

Description:

Each participant will wear the Auricular stimulation device during the 30 minutes mindfulness exercise portion of the 2-hour MBSR group sessions. Additionally, they will wear the devices during the 20-minute at-home MBSR activities for the remaining six days of the week, totaling 120 minutes. The total expected duration of device usage per week will be 2.5 hours or 150 minutes. Mindfulness Based Stress Reduction: This is a standardized and structured training session that was originally developed by Jon Kabat-Zinn. Its primary objective is to assist participants in accepting their current condition and eliminating negative associations with it. All study participants will receive MBSR

Treatment:

Device: Vibrational stimulation

Sham + MBSR

Sham Comparator group

Description:

Each participant will wear the Sham device device during the 30 minutes mindfulness exercise portion of the 2-hour MBSR group sessions. Additionally, they will wear the devices during the 20-minute at-home MBSR activities for the remaining six days of the week, totaling 120 minutes. The total expected duration of device usage per week will be 2.5 hours or 150 minutes. Mindfulness Based Stress Reduction: This is a standardized and structured training session that was originally developed by Jon Kabat-Zinn. Its primary objective is to assist participants in accepting their current condition and eliminating negative associations with it. All study participants will receive MBSR

Treatment:

Device: Sham