An interventional study of transcutaneous auricular vagus nerve stimulation 30/30 and transcutaneous auricular vagus nerve stimulation 10/10 in Healthy, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by University of Miami · Not applicable, Interventional, and Other
The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.
University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the group taVNS 30/30 will be in this group for up to 3 hours.
Device: transcutaneous auricular vagus nerve stimulation 30/30
Participants in the group taVNS 10/10 will be in this group for up to 3 hours.
Device: transcutaneous auricular vagus nerve stimulation 10/10
Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a 30 second on and 30 second off, for 1 hour, in-person.
Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN). Participants in this group will first receive taVNS with a 10 second on and 10 second off, for 1 hour, in-person.
Tolerability Measured by Tolerability Questionnaire
Tolerability will be assessed with a questionnaire with scores ranging from 0 -10 (with 0 being no irritation or discomfort and 10 being the worst possible irritation or discomfort) for irritation from tingling/tickling/pricking during taVNS.
Time frame: 3 hours
Tolerability Measured by Self-report
The number of participants who reported mild pain with the intervention.
Time frame: 3 hours
Change in Heart Rate Variability (HRV)
HRV will be measured with an H10 chest strap device. Values after stimulation will be subtracted from baseline values; thus, a positive number will indicate an increase in HRV post taVNS measured in milliseconds.
Time frame: Baseline and 3 hours
| Milestone | taVNS 30/30 Group | taVNS 10/10 Group |
|---|---|---|
| Started | 17 | 14 |
| Completed | 17 | 14 |
| Not completed | 0 | 0 |
| Milestone | taVNS 30/30 Group | taVNS 10/10 Group |
|---|---|---|
| Started | 17 | 14 |
| Completed | 17 | 12 |
| Not completed | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Milestone | taVNS 30/30 Group | taVNS 10/10 Group |
|---|---|---|
| Started | 17 | 12 |
| Completed | 17 | 12 |
| Not completed | 0 | 0 |
Tolerability will be assessed with a questionnaire with scores ranging from 0 -10 (with 0 being no irritation or discomfort and 10 being the worst possible irritation or discomfort) for irritation from tingling/tickling/pricking during taVNS.
| score on a scale | taVNS 30/30 Group | taVNS 10/10 Group |
|---|---|---|
| Tolerability Measured by Tolerability Questionnaire | 2.2 ± 1.8 | 2.2 ± 1.8 |
The number of participants who reported mild pain with the intervention.
| Participants | taVNS 30/30 Group | taVNS 10/10 Group |
|---|---|---|
| Tolerability Measured by Self-report | 7 | 8 |
HRV will be measured with an H10 chest strap device. Values after stimulation will be subtracted from baseline values; thus, a positive number will indicate an increase in HRV post taVNS measured in milliseconds.
| Milliseconds | taVNS 30/30 Group | taVNS 10/10 Group |
|---|---|---|
| Change in Heart Rate Variability (HRV) | 7.2 ± 12.2 | 4.4 ± 12.1 |
Collected over 72 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| taVNS 30/30 Group | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| taVNS 10/10 Group | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Continuous(years) | taVNS 30/30 Group | taVNS 10/10 Group | Total |
|---|---|---|---|
| Mean | 31.0 ± 13.0 | 29.2 ± 6.8 | 30.2 ± 10.7 |
| Sex: Female, Male(Participants) | taVNS 30/30 Group | taVNS 10/10 Group | Total |
|---|---|---|---|
| Female | 9 | 7 | 16 |
| Male | 8 | 7 | 15 |
| Ethnicity (NIH/OMB)(Participants) | taVNS 30/30 Group | taVNS 10/10 Group | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 7 | 11 |
| Not Hispanic or Latino | 13 | 7 | 20 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | taVNS 30/30 Group | taVNS 10/10 Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 13 | 12 | 25 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
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