How Does the Length of Pulse Trains and Pulse Intervals Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Tolerability Measured by Tolerability Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
- •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).
Arms & Interventions
taVNS 30/30 group
Participants in the group taVNS 30/30 will be in this group for up to 3 hours.
Intervention: transcutaneous auricular vagus nerve stimulation 30/30 (Device)
taVNS 10/10 group
Participants in the group taVNS 10/10 will be in this group for up to 3 hours.
Intervention: transcutaneous auricular vagus nerve stimulation 10/10 (Device)
Outcomes
Primary Outcomes
Tolerability Measured by Tolerability Questionnaire
Time Frame: 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
Time Frame: 3 hours
The number of participants who reported mild pain with the intervention.
Secondary Outcomes
- Change in Heart Rate Variability (HRV)(Baseline and 3 hours)
Investigators
Marlon Wong
Associate Professor of Clinical
University of Miami