taVNS Dosage Study 2

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Device: Biphasic transcutaneous auricular vagus nerve stimulation; Device: Monophasic transcutaneous auricular vagus nerve stimulation

• Registration Number: NCT06614933
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-26
• Status Verified: 2024-12
• Study Start: 2024-12-15
• Last Update Submitted: 2024-12-29
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Biphasic followed by monophasic taVNS group	Biphasic transcutaneous auricular vagus nerve stimulation	Participants in the group "Biphasic followed by monophasic taVNS" will be in this group for up to 6 hours.
Biphasic followed by monophasic taVNS group	Monophasic transcutaneous auricular vagus nerve stimulation	Participants in the group "Biphasic followed by monophasic taVNS" will be in this group for up to 6 hours.
Monophasic followed by biphasic taVNS group	Biphasic transcutaneous auricular vagus nerve stimulation	Participants in the group "monophasic followed by biphasic" will be in this group for up to 6 hours.
Monophasic followed by biphasic taVNS group	Monophasic transcutaneous auricular vagus nerve stimulation	Participants in the group "monophasic followed by biphasic" will be in this group for up to 6 hours.

Primary Outcome Measures

Name	Time	Method
Tolerability measured by tolerability questionnaire	Up to 3 hours.	Tolerability will be assessed with a questionnaire with scores ranging from 0 (no discomfort)-10 (worst pain imaginable) for comfort.
Tolerability measured by self-report	Up to 3 hours.	Tolerability will be assessed using semi-structured interviews. Investigators will ask about the sensations experienced and preferences. Participants will self-report their responses.

Secondary Outcome Measures

Name	Time	Method
Change in heart rate variability (HRV)	Baseline and up to 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.

Trial Locations

Locations (1)

University of Miami, Plumer Building; 🇺🇸 Coral Gables, Florida, United States