Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2025-01-27
2025-07-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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.
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
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Jay F. Piccirillo, MD
Professor of Otolaryngology
Principal Investigators
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Jay F Piccirillo, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University
St Louis, Missouri, United States
Countries
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References
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Other Identifiers
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202411118
Identifier Type: -
Identifier Source: org_study_id
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