Vagus Auricular Stimulation for Tinnitus

NCT06821893 | Completed FDA Device

• 1 other identifier: 202411118
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tinnitus

Keywords

Audiology; Otolaryngology; Mindfulness Based Stress Reduction (MBSR); auricular branch of vagus nerve; neuromodulation; transcutaneous stimulation

Outcome Measures

Primary Outcomes (1)

• Responder proportion

  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 Outcomes (5)

• Proportion of adequate device users

  Week 9

• Adverse events

  Week 9, and 13

• Proportion of participants reporting improvement on CGI-I

  Week 9 and 13

• Change in CGI-S

  Week 9, and 13

• Responder proportion at 4weeks post-intervention follow up

  Week 13

Study Arms (2)

Vibrational stimulation + MBSR

EXPERIMENTAL

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

Sham + MBSR

SHAM COMPARATOR

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

Interventions

Vibrational stimulation DEVICE

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.

Also known as: Auricular Stimulation

Vibrational stimulation + MBSR

Sham DEVICE

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.

Also known as: Sham device

Sham + MBSR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (55)

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  BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jay F Piccirillo, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participants, and research team will be unaware of whether device A or B corresponds to the stimulation or sham device during the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology

Model Details: This pilot study is a randomized, double-blinded controlled trial of adult participants with chronic, moderate to severe bothersome subjective tinnitus.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 12, 2025
• Study Start: January 27, 2025
• Primary Completion: June 27, 2025
• Study Completion: July 27, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)