40
Participants
Start Date
January 27, 2025
Primary Completion Date
June 27, 2025
Study Completion Date
July 27, 2025
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."
Washington University, St Louis
Washington University School of Medicine
OTHER