N/A
N=30
How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT06614933 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Tolerability Measured by Tolerability Questionnaire — 2; 2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biphasic transcutaneous auricular vagus nerve stimulation (Device); Monophasic transcutaneous auricular vagus nerve stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability Measured by Tolerability Questionnaire |
2; 2 | — |
| PRIMARY Tolerability Measured by Self Report |
30; 30 | — |
| SECONDARY Change in Heart Rate Variability (HRV) |
3.30; 6.30 | — |
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.
Eligibility Criteria
Inclusion Criteria
- between the ages of 18-80 years
- English speaking (must be able to consent and complete the interviews in English)
Exclusion Criteria
- chronic pain (average intensity >2/10 on 0-10 scale, for longer than 3 months)
- acute pain of intensity greater than 3/10
- chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease)
- any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
- pregnancy
- currently taking Buprenorphine or recently stopped taking (within 1 month)
- presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
- implants in the head or neck, cochlear implants, or pacemaker
- head or neck metastasis or recent ear trauma
- history of epilepsy
- history of autonomic nervous system dysfunction (e.g., postural orthostatic tachycardia syndrome).
Data sourced from ClinicalTrials.gov (NCT06614933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.