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NCT05791383
taVNS on the Inpatient Psychiatric Unit
NA trial testing transcutaneous auricular neurostimulation in Depression, Anxiety in 10 participants. Completed in 24 March 2024.
24 March 2024
Quick facts
| Lead sponsor | Medical University of South Carolina |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 10 |
| Start date | 1 December 2022 |
| Primary completion | 24 March 2024 |
| Estimated completion | 24 March 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- transcutaneous auricular neurostimulation
Conditions studied
- Depression, Anxiety — all drugs for Depression, Anxiety →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05791383
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05791383 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of South Carolina
- Last refreshed: 6 April 2025
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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