Vagus Auricular Stimulation for Tinnitus
(VAST Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByJay F Piccirillo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with chronic, moderate to severe tinnitus that's bothersome. Participants must be willing to undergo an 8-week virtual Mindfulness-Based Stress Reduction program and can't have conditions that would interfere with the study or its treatments.

Inclusion Criteria

Ability to read, write, speak, and understand English

I am 18 years old or older.

Available for the entire period of the study including one month follow-up after completion of 8-week intervention period

+2 more

Exclusion Criteria

I am over 70 years old.

Pregnant or planning to become pregnant during the study period

Previous participation in an auricular stimulation trial

+9 more

Participant Groups

The study tests vibrational stimulation on the ear (active treatment) versus a sham (placebo) control, both combined with MBSR therapy. It aims to see if this can reduce the annoyance of tinnitus and improve well-being, measured before, after treatment, and one month later.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Vibrational stimulation + MBSRExperimental Treatment1 Intervention

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

Group II: Sham + MBSRPlacebo Group1 Intervention

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