Vagus Auricular Stimulation for Tinnitus (VAST)

November 13, 2025 updated by: Jay F. Piccirillo, MD, Washington University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vibrational stimulation + MBSR

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
Device: Vibrational stimulation

The auricular stimulation device produces continuous vibrational stimulation directly to the conchae of the auricle. It is designed to stimulate the vagus nerve for neuromodulation to treat a variety of clinical indications. The system includes a pulse generator and an ear electrode device. Participants will use a vibration motor in a custom-created soft plastic clip for the left ear.

Each participant will receive their own device by mail, which they will wear during the 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.

Other Names:
  • Auricular Stimulation
Sham Comparator: Sham + MBSR

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
Device: Sham

The sham device looks and is used identically to the auricular stimulation device, but does not produce vibrational stimulation. There will be no difference in the usage directions of the sham device compared to the stimulation device.

Each participant will receive their own device by mail, which they will wear 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.

Other Names:
  • Sham device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder proportion
Time Frame: Week 9

The responder proportion will be defined as number of participants with >12- point change in Tinnitus Severity Short Form [TSSF] score at the end of treatment compared to baseline, divided by the total number of participants in each group.

TSSF score ranges from 0 (mild) to 100 (severe) The responder proportion will be compared between the active and sham group.
Week 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of adequate device users
Time Frame: Week 9

Feasibility of the auricular device will be assessed by recording the duration of device usage each week, summed over 8 weeks, and calculated as a percentage of the total expected usage which is 2.5 hours(per week) x 8 for each participant.

Participants with >80% device usage will be defined as adequate device users.

The proportion of adequate users will be compared between the stimulation and sham groups
Week 9
Adverse events
Time Frame: Week 9, and 13
The summary of reported adverse events after 8-weeks of the study period, and after 4 weeks post-intervention will be compared between stimulation and sham groups.
Week 9, and 13
Proportion of participants reporting improvement on CGI-I
Time Frame: Week 9 and 13

Participants will rate their perception of their response to tinnitus treatment using the CGI-I scale.

The proportion of participants reporting improvement will be calculated as the number of participants with a CGI-I score ≤3 (defined as reporting improvement) divided by the total number of participants in each group.

The proportion will be compared between the active and sham group after 8 weeks of intervention, and at 4 weeks post-intervention.

Clinical Global Impression of Improvement Scale:

The CGI-I scale is a self-reported measure widely used in previous studies and adapted from validated scales used in psychiatric studies.

Participants will answer the question, "Overall, how do you rate your response to tinnitus treatment?"

It offers 7 response options ranging from: 1-Very Much Improved, 2-Much Improved, 3-Minimally Improved, 4-No Change, 5-Minimally Worse, 6-Much Worse, to 7-Very Much Worse.
Week 9 and 13
Change in CGI-S
Time Frame: Week 9, and 13

The change in CGI-S score from baseline after 8 weeks of intervention and 4 weeks post intervention will be compared between the active and sham group.

Clinical Global Impression of Severity (CGI-S) Scale:

The CGI-S scale assesses the perceived severity problem level of tinnitus symptoms, with 5 response options ranging from 1-"Not bothered", 2-"Bothered a little, but not much", 3-"Bothered more than a little, but not a lot", 4-"Bothered a lot", to 5-"Extremely bothered.

It poses the question, "Please indicate the overall amount of disturbance or "bother" that you experience in your life as a result of your tinnitus."
Week 9, and 13
Responder proportion at 4weeks post-intervention follow up
Time Frame: Week 13

Responder proportion will be defined as number of participants with >12- point change in Tinnitus Severity Short Form [TSSF] score at 4 weeks after the end of treatment compared to baseline divided by the total number of participants in each group.

TSSF score ranges from 0 (mild) to 100 (severe) The responder proportion will be compared between the active and sham group.
Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Jay F Piccirillo, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2025

Primary Completion (Actual)

June 27, 2025

Study Completion (Actual)

July 27, 2025

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202411118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tinnitus

Clinical Trials on Vibrational stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe