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NCT05791383

taVNS on the Inpatient Psychiatric Unit

Completed NA Last updated 6 April 2025
What this trial tests

NA trial testing transcutaneous auricular neurostimulation in Depression, Anxiety in 10 participants. Completed in 24 March 2024.

Timeline
1 December 2022
Primary endpoint
24 March 2024
24 March 2024

Quick facts

Lead sponsorMedical University of South Carolina
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposedevice feasibility
Enrollment10
Start date1 December 2022
Primary completion24 March 2024
Estimated completion24 March 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of South Carolina

Who can join

18 and older, any sex, with Depression, Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Accelerated Transcutaneous Auricular Vagus Nerve Stimulation for Inpatient Depression and Anxiety: The iWAVE Open Label Pilot Trial.
    Austelle CW, Cox SS, Connolly DJ, Baker Vogel B, et al · · 2025 · cited 6× · PMID 40117415 · DOI 10.1016/j.neurom.2025.02.003

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Other recruiting trials for Depression, Anxiety

Currently open trials in the same condition.

Other Medical University of South Carolina trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05791383.

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