NCT05791383

taVNS on the Inpatient Psychiatric Unit

Managing Inpatient Neuropsychiatric Conditions Using Wearable Auricular Vagus Stimulation: The iWAVE Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a research study to find out if mental health symptoms in patients admitted to the Institute of Psychiatry are affected by a form of ear stimulation called transcutaneous auricular vagus nerve stimulation, or taVNS. Participants will receive ear stimulation during their inpatient treatment at the Institute of Psychiatry. Participants will be randomly assigned to either receive ear stimulation for 1 day (up to 9 treatments over the course of a single day) or 3 days (up to 3 treatments per day), and will have a 50:50 chance of being in either group (like the flip of a coin). Each treatment will last up to 30 minutes and there will be a break of at least 30 minutes in between treatments. The study team will ask participants to complete a group of questionnaires at the beginning and end of the study. In addition, there are several questionnaires that will be completed daily while participants are receiving ear stimulation. Participants in the 1 day stimulation group will also receive 2 days of follow up questionnaires after the initial day of stimulation. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and sleep. The ear stimulation treatments will not interfere with the care subjects are receiving from the medical team. In order to qualify for this study, participants must be actively receiving inpatient care at the MUSC Institute of Psychiatry.

Conditions

• Depression, Anxiety

Interventions

Type	Name	Description
DEVICE	transcutaneous auricular neurostimulation	All transcutaneous auricular neurostimulation procedures will be conducted using the Spark Biomedical device. We will use stimulation parameters similar to ongoing taVNS work (25Hz, 500us pulse width) and a duty cycle of 1 minute on, 30 s off, repeated for 30 minutes. taVNS sessions are considered complete after 30minutes. Subsequent taVNS sessions may be repeated no less than 30minutes after prior session completion. All subjects will begin with taVNS administered to the left auricle, however, if they begin to experience any irritation or discomfort of the left ear, study team staff will offer subjects the option to stop stimulation or switch stimulation to the right auricle.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-03-24
• Completion: 2024-03-24
• First posted: 2023-03-30
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study