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Behavioural Intervention

taVNS 30/30 followed by taVNS 10/10 group for Healthy Subjects

N/A

Recruiting

Led By Marlon Wong, DPT, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 18-80 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 hours.

Awards & highlights

Study Summary

This trial aims to study how different types of gentle electrical stimulation applied to the ear, called transcutaneous auricular vagus nerve stimulation (taVNS), impact comfort, tolerability, and effectiveness

Who is the study for?

This trial is for healthy individuals who are interested in participating in a study to evaluate the effects of a non-invasive electrical stimulation therapy applied to the ear.Check my eligibility

What is being tested?

The study is testing two different dosages of transcutaneous auricular vagus nerve stimulation (taVNS), one with longer and another with shorter duration, to see how they affect comfort, tolerability, and effectiveness.See study design

What are the potential side effects?

Potential side effects may include discomfort at the site of stimulation on the ear, headache, dizziness or lightheadedness. These are typically mild as taVNS is considered a gentle form of therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 hours.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 hours.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 hours. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tolerability measured by self-report

Tolerability measured by tolerability questionnaire

Secondary outcome measures

Change in heart rate variability (HRV)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: taVNS 30/30 followed by taVNS 10/10 groupExperimental Treatment2 Interventions

Participants in the group taVNS 30/30 followed by taVNS 10/10 will be in this group for up to 6 hours.

Group II: taVNS 10/10 followed by taVNS 30/30 groupActive Control2 Interventions

Participants in the group taVNS 10/10 followed by taVNS 30/30 will be in this group for up to 6 hours.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

905 Previous Clinical Trials

410,228 Total Patients Enrolled

Marlon Wong, DPT, PhDPrincipal InvestigatorUniversity of Miami

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study open to individuals who are older than 75 years of age?

"Eligible candidates for this study must be over 18 years old but under the age of 80."

Answered by AI

Which individuals meet the eligibility criteria for participation in this clinical trial?

"To be eligible for participation in this study, individuals must meet the criteria of being healthy volunteers aged between 18 and 80 years. The trial aims to enroll a total of 30 participants."

Answered by AI

What is the current number of participants being enlisted for this clinical trial?

"Indeed, as per clinicaltrials.gov, this investigation is actively seeking participants. It was initially listed on April 13th, 2024 and last revised on April 19th, 2024. The research aims to enroll a total of 30 individuals at one designated site."

Answered by AI

Are new participants currently being accepted for enrollment in this ongoing medical study?

"Indeed, the details available on clinicaltrials.gov clearly indicate that this particular medical trial is actively seeking suitable participants. This study was initially listed on April 13th, 2024 and underwent its most recent update on April 19th, 2024. The research team aims to recruit a total of 30 patients from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1

Marlon Wong 2024. "Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06381102.

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