Vagus Auricular Stimulation for Tinnitus (NCT06821893) | Clinical Trial Compass
CompletedNot Applicable
Vagus Auricular Stimulation for Tinnitus
United States40 participantsStarted 2025-01-27
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.