Trial Outcomes & Findings for How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation? (NCT NCT06614933)
NCT ID: NCT06614933
Last Updated: 2026-05-28
Results Overview
Tolerability will be assessed with a questionnaire with scores ranging from 0 (no discomfort) to 10 (worst pain imaginable) for comfort.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Up to 3 hours
Results posted on
2026-05-28
Participant Flow
Only healthy individuals (no patients) will be recruited for this study. All recruitment will be in accordance with the UM Human Subjects and Research Office guidelines. We will only recruit participants via flyers. Participants will be recruited from the University of Miami Department of Physical Therapy, The University of Miami Student Complex, and The University of Miami Health and Wellness Centers, and the community.
All participants will receive both taVNS protocols in random order. Thus, half of the participants will receive Protocol-1 first followed by Protocol-2, and the other half will receive Protocol-2 first followed by Protocol-1.
Participant milestones
| Measure |
taVNS Biphasic Waveform Group
Participants in the taVNS biphasic waveform group will be in this group for up to 6 hours.
transcutaneous auricular vagus nerve stimulation biphasic waveform: 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 continuous biphasic waveform, for one hour, in person.
|
taVNS Monophasic Waveform Group
Participants in the taVNS monophasic waveform group will be in this group for up to 6 hours.
transcutaneous auricular vagus nerve stimulation monophasic waveform: 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 pulsed 30 seconds on/30 seconds off monophasic waveform, for one hour, in person.
|
|---|---|---|
|
Period 1-Protocol 1
STARTED
|
16
|
14
|
|
Period 1-Protocol 1
COMPLETED
|
16
|
14
|
|
Period 1-Protocol 1
NOT COMPLETED
|
0
|
0
|
|
Period 2-Protocol 2
STARTED
|
16
|
14
|
|
Period 2-Protocol 2
COMPLETED
|
16
|
14
|
|
Period 2-Protocol 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?
Baseline characteristics by cohort
| Measure |
taVNS Biphasic Waveform Group
n=16 Participants
Participants in the taVNS biphasic waveform group will be in this group for up to 6 hours.
transcutaneous auricular vagus nerve stimulation biphasic waveform: 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 continuous biphasic waveform, for one hour, in person.
|
taVNS Monophasic Waveform Group
n=14 Participants
Participants in the taVNS monophasic waveform group will be in this group for up to 6 hours.
transcutaneous auricular vagus nerve stimulation monophasic waveform: 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 pulsed 30 seconds on/30 seconds off monophasic waveform, for one hour, in person.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24 years
n=51 Participants
|
27.50 years
n=14 Participants
|
25 years
n=65 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
15 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=51 Participants
|
8 Participants
n=14 Participants
|
15 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=51 Participants
|
12 Participants
n=14 Participants
|
27 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=51 Participants
|
7 Participants
n=14 Participants
|
12 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=51 Participants
|
7 Participants
n=14 Participants
|
18 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: Up to 3 hoursTolerability will be assessed with a questionnaire with scores ranging from 0 (no discomfort) to 10 (worst pain imaginable) for comfort.
Outcome measures
| Measure |
taVNS Biphasic Waveform Group
n=30 Participants
Participants in the taVNS biphasic waveform group will be in this group for up to 6 hours.
transcutaneous auricular vagus nerve stimulation biphasic waveform: 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 continuous biphasic waveform, for one hour, in person.
|
taVNS Monophasic Waveform Group
n=30 Participants
Participants in the taVNS monophasic waveform group will be in this group for up to 6 hours.
transcutaneous auricular vagus nerve stimulation monophasic waveform: 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 pulsed 30 seconds on/30 seconds off monophasic waveform, for one hour, in person.
|
|---|---|---|
|
Tolerability Measured by Tolerability Questionnaire
|
2 score on a scale
Standard Deviation 2.07
|
2 score on a scale
Standard Deviation 1.79
|
PRIMARY outcome
Timeframe: Up to 3 hoursTolerability will be assessed by self-report using semi-structured interviews conducted at the end of each study visit. Participants will report whether they experienced mild pain during each transcutaneous auricular vagus nerve stimulation (taVNS) protocol. The outcome measure is the count of participants who reported mild pain, as collected during interviews conducted at the end of each visit.
Outcome measures
| Measure |
taVNS Biphasic Waveform Group
n=30 Participants
Participants in the taVNS biphasic waveform group will be in this group for up to 6 hours.
transcutaneous auricular vagus nerve stimulation biphasic waveform: 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 continuous biphasic waveform, for one hour, in person.
|
taVNS Monophasic Waveform Group
n=30 Participants
Participants in the taVNS monophasic waveform group will be in this group for up to 6 hours.
transcutaneous auricular vagus nerve stimulation monophasic waveform: 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 pulsed 30 seconds on/30 seconds off monophasic waveform, for one hour, in person.
|
|---|---|---|
|
Tolerability Measured by Self Report
|
30 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 3 hoursHeart rate variability (HRV) will be measured using an H10 chest strap device and expressed in milliseconds. Values after stimulation will be subtracted from baseline values; thus, a positive number will indicate an increase in HRV post taVNS.
Outcome measures
| Measure |
taVNS Biphasic Waveform Group
n=30 Participants
Participants in the taVNS biphasic waveform group will be in this group for up to 6 hours.
transcutaneous auricular vagus nerve stimulation biphasic waveform: 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 continuous biphasic waveform, for one hour, in person.
|
taVNS Monophasic Waveform Group
n=30 Participants
Participants in the taVNS monophasic waveform group will be in this group for up to 6 hours.
transcutaneous auricular vagus nerve stimulation monophasic waveform: 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 pulsed 30 seconds on/30 seconds off monophasic waveform, for one hour, in person.
|
|---|---|---|
|
Change in Heart Rate Variability (HRV)
|
3.30 milliseconds
Standard Deviation 22.66
|
6.30 milliseconds
Standard Deviation 21.99
|
Adverse Events
taVNS Biphasic Waveform Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
taVNS Monophasic Waveform Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place