Healthy
Conditions
Brief summary
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.
Interventions
DEVICEtranscutaneous 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.
DEVICEtranscutaneous 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.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. between the ages of 18-80 years 2. English speaking (must be able to consent and complete the interviews in English)
Exclusion criteria
1. chronic pain (average intensity >2/10 on 0-10 scale, for longer than 3 months) 2. acute pain of intensity greater than 3/10 3. chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease) 4. any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia) 5. pregnancy 6. currently taking Buprenorphine or recently stopped taking (within 1 month) 7. presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews 8. implants in the head or neck, cochlear implants, or pacemaker 9. head or neck metastasis or recent ear trauma 10. history of epilepsy 11. history of autonomic nervous system dysfunction (e.g., postural orthostatic tachycardia syndrome).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability Measured by Tolerability Questionnaire | 3 hours | 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. |
| Tolerability Measured by Self-report | 3 hours | The number of participants who reported mild pain with the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate Variability (HRV) | Baseline and 3 hours | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 14 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout 5 Days | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | taVNS 10/10 Group | Total | taVNS 30/30 Group |
|---|---|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 6.8 | 30.2 years STANDARD_DEVIATION 10.7 | 31.0 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 11 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 20 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 25 Participants | 13 Participants |
| Sex: Female, Male Female | 7 Participants | 16 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 15 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 31 |
| other Total, other adverse events | 0 / 29 | 0 / 31 |
| serious Total, serious adverse events | 0 / 29 | 0 / 31 |
Outcome results
Primary
Tolerability Measured by Self-report
The number of participants who reported mild pain with the intervention.
Time frame: 3 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| taVNS 30/30 Group | Tolerability Measured by Self-report | 7 Participants |
| taVNS 10/10 Group | Tolerability Measured by Self-report | 8 Participants |
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.
Time frame: 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| taVNS 30/30 Group | Tolerability Measured by Tolerability Questionnaire | 2.2 score on a scale | Standard Deviation 1.8 |
| taVNS 10/10 Group | Tolerability Measured by Tolerability Questionnaire | 2.2 score on a scale | Standard Deviation 1.8 |
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.
Time frame: Baseline and 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| taVNS 30/30 Group | Change in Heart Rate Variability (HRV) | 7.2 Milliseconds | Standard Deviation 12.2 |
| taVNS 10/10 Group | Change in Heart Rate Variability (HRV) | 4.4 Milliseconds | Standard Deviation 12.1 |