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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| taVNS 30/30 group | Experimental | Participants in the group taVNS 30/30 will be in this group for up to 3 hours. |
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| taVNS 10/10 group | Experimental | Participants in the group taVNS 10/10 will be in this group for up to 3 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous auricular vagus nerve stimulation 30/30 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 hours |
| Tolerability Measured by Self-report | The number of participants who reported mild pain with the intervention. | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlon Wong, DPT, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42098884 | Derived | Gonzalez G, O'Malley M, Bolanos J, Taylor D, McTeague LM, Canepa A, Wong ML. Participant-centered tolerability of transcutaneous auricular vagus nerve stimulation: insights from two crossover studies. Bioelectron Med. 2026 May 8;12(1):12. doi: 10.1186/s42234-026-00206-y. |
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Participants will be randomized in Period 1 to receive either taVNS 30/30 first or taVNS 10/10 first then the participants will washout for 5 days and will then switch and crossover in Period 2 to receive the opposite treatment from what they received in Period 1 which will be either the taVNS 30/30 first or the taVNS 10/10 first depending on what they were first originally randomized to in Period 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | taVNS 30/30 Group | Participants in the group taVNS 30/30 will be in this group for up to 3 hours. transcutaneous auricular vagus nerve stimulation 30/30: 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. |
| FG001 | taVNS 10/10 Group | Participants in the group taVNS 10/10 will be in this group for up to 3 hours. 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 10 second on and 10 second off, for 1 hour, in-person. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 |
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| Washout 5 Days |
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| Intervention 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | taVNS 30/30 Group | Participants in the group taVNS 30/30 will be in this group for up to 3 hours. Transcutaneous auricular vagus nerve stimulation 30/30: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 hours |
|
72 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | taVNS 30/30 Group | Participants in the group taVNS 30/30 will be in this group for up to 3 hours. transcutaneous auricular vagus nerve stimulation 30/30: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marlon Wong, Associate Professor of Clinical | University of Miami | 3052842670 | mwong2@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2024 | Jun 23, 2025 | Prot_SAP_000.pdf |
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| transcutaneous auricular vagus nerve stimulation 10/10 | Device | 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. |
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| NOT COMPLETED |
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| BG001 | taVNS 10/10 Group | Participants in the group taVNS 10/10 will be in this group for up to 3 hours. 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 10 second on and 10 second off, for 1 hour, in-person. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 |
| taVNS 10/10 Group |
Participants in the group taVNS 10/10 will be in this group for up to 3 hours. 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 10 second on and 10 second off, for 1 hour, in-person. |
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| Primary | Tolerability Measured by Self-report | The number of participants who reported mild pain with the intervention. | Posted | Count of Participants | Participants | 3 hours |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Milliseconds | Baseline and 3 hours |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | taVNS 10/10 Group | Participants in the group taVNS 10/10 will be in this group for up to 3 hours. 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 10 second on and 10 second off, for 1 hour, in-person. | 0 | 31 | 0 | 31 | 0 | 31 |
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