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TinnitusVASTNCT06821893

Vagus Auricular Stimulation for Tinnitus

A study testing Vibrational stimulation in people with Tinnitus, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Tinnitus
What is being tested?
Vibrational stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
27 Jan 2025to 27 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

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.

Read the 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.

Conditions
Tinnitus
Being tested
Vibrational stimulation, Sham
Keywords
Audiology, Otolaryngology, Mindfulness Based Stress Reduction (MBSR), auricular branch of vagus nerve, neuromodulation, transcutaneous stimulation
Medical subject headings
Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vibrational stimulationDevice

    Also called Auricular 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.

  • ShamDevice

    Also called 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.

Study groups in NCT06821893
Study groupRoleWhat they receive
Vibrational stimulation + MBSRExperimentalEach 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
Receives: Device: Vibrational stimulation
Sham + MBSRSham comparatorEach 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
Receives: Device: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 9

Secondary outcomes (5)

  1. Proportion of adequate device users

    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

    Measured: Week 9

  2. Adverse events

    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.

    Measured: Week 9, and 13

  3. Proportion of participants reporting improvement on CGI-I

    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.

    Measured: Week 9 and 13

  4. Change in CGI-S

    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."

    Measured: Week 9, and 13

  5. Responder proportion at 4weeks post-intervention follow up

    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.

    Measured: Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2025
  2. Study start27 Jan 2025
  3. Primary completion27 Jun 2025
  4. Study completion27 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This pilot study is a randomized, double-blinded controlled trial of adult participants with chronic, moderate to severe bothersome subjective tinnitus.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06821893
Sponsor's protocol ID
202411118
Acronym
VAST
Status last verified
Nov 2025
First submitted
4 Feb 2025
Last updated
14 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Batts S, Stankovic KM. Tinnitus prevalence, associated characteristics, and related healthcare use in the United States: a population-level analysis. Lancet Reg Health Am. 2024 Jan 6;29:100659. doi: 10.1016/j.lana.2023.100659. eCollection 2024 Jan.

    PubMed 38269207

  • Tang D, Li H, Chen L. Advances in Understanding, Diagnosis, and Treatment of Tinnitus. Adv Exp Med Biol. 2019;1130:109-128. doi: 10.1007/978-981-13-6123-4_7.

    PubMed 30915704

  • Beukes EW, Andersson G, Allen PM, Manchaiah V, Baguley DM. Effectiveness of Guided Internet-Based Cognitive Behavioral Therapy vs Face-to-Face Clinical Care for Treatment of Tinnitus: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Dec 1;144(12):1126-1133. doi: 10.1001/jamaoto.2018.2238.

    PubMed 30286238

  • Miller L. Cognitive behavioral therapy for patients suffering with tinnitus distress. JAAPA. 2023 Sep 1;36(9):13-16. doi: 10.1097/01.JAA.0000947036.33633.84.

    PubMed 37561667

  • Butt MF, Albusoda A, Farmer AD, Aziz Q. The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat. 2020 Apr;236(4):588-611. doi: 10.1111/joa.13122. Epub 2019 Nov 19.

    PubMed 31742681

  • Hilz MJ. Transcutaneous vagus nerve stimulation - A brief introduction and overview. Auton Neurosci. 2022 Dec;243:103038. doi: 10.1016/j.autneu.2022.103038. Epub 2022 Sep 27.

    PubMed 36201901

  • Kim AY, Marduy A, de Melo PS, Gianlorenco AC, Kim CK, Choi H, Song JJ, Fregni F. Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Sci Rep. 2022 Dec 21;12(1):22055. doi: 10.1038/s41598-022-25864-1.

    PubMed 36543841

  • Byun YJ, Lee JA, Nguyen SA, Rizk HG, Meyer TA, Lambert PR. Transcutaneous Electrical Nerve Stimulation for Treatment of Tinnitus: A Systematic Review and Meta-analysis. Otol Neurotol. 2020 Aug;41(7):e767-e775. doi: 10.1097/MAO.0000000000002712.

    PubMed 32472915

  • Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0.

    PubMed 22156949

  • Langguth B, De Ridder D. Minimal Clinically Important Difference of Tinnitus Outcome Measurement Instruments-A Scoping Review. J Clin Med. 2023 Nov 15;12(22):7117. doi: 10.3390/jcm12227117.

    PubMed 38002730

  • Frumkin MR, Kallogjeri D, Piccirillo JF, Beukes EW, Manchaiah V, Andersson G, Rodebaugh TL. Development and Preliminary Evaluation of the Tinnitus Severity Short Form. Am J Audiol. 2021 Jun 14;30(2):404-415. doi: 10.1044/2021_AJA-20-00164. Epub 2021 May 24.

    PubMed 34029120

  • Natarajan N, Batts S, Stankovic KM. Noise-Induced Hearing Loss. J Clin Med. 2023 Mar 17;12(6):2347. doi: 10.3390/jcm12062347.

    PubMed 36983347

  • Kang HJ, Kang DW, Kim SS, Oh TI, Kim SH, Yeo SG. Analysis of Chronic Tinnitus in Noise-Induced Hearing Loss and Presbycusis. J Clin Med. 2021 Apr 19;10(8):1779. doi: 10.3390/jcm10081779.

    PubMed 33921850

  • Saeed S, Khan QU. The Pathological Mechanisms and Treatments of Tinnitus. Discoveries (Craiova). 2021 Sep 30;9(3):e137. doi: 10.15190/d.2021.16. eCollection 2021 Jul-Sep.

    PubMed 35350720

  • Dehaene S, Kerszberg M, Changeux JP. A neuronal model of a global workspace in effortful cognitive tasks. Proc Natl Acad Sci U S A. 1998 Nov 24;95(24):14529-34. doi: 10.1073/pnas.95.24.14529.

    PubMed 9826734

Questions about this trial

What is this clinical trial studying?

A study testing Vibrational stimulation in people with Tinnitus, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder proportion (time frame: Week 9). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06821893, which also lists 55 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.

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