← Back to Search

Behavioural Intervention

taVNS for Atrial Fibrillation

N/A

Waitlist Available

Led By Harald M Stauss, MD, PhD

Research Sponsored by Burrell College of Osteopathic Medicine

Eligibility Criteria Checklist

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

Must have

Persistent atrial fibrillation

On anti-coagulation throughout the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after one week of treatment or sham treatment

Awards & highlights

Study Summary

This trial aims to test the effects of a non-invasive treatment, taVNS, on heart rate in patients with persistent atrial fibrillation. Participants self-administer taVNS for two weeks with an electrode in the left ear. ECG is monitored during both weeks.

Who is the study for?

This trial is for adults over 18 with persistent atrial fibrillation who are on anticoagulation therapy. It's not suitable for pregnant individuals, those under 18, or anyone with a history of vestibulocochlear nerve issues like hearing loss or epilepsy.Check my eligibility

What is being tested?

The study tests if non-invasive ear stimulation (taVNS) can reduce heart rate in patients with persistent atrial fibrillation. Participants will self-administer taVNS daily and have their heart activity monitored to see if there's a difference in heart rate reduction.See study design

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, skin irritation from the ECG patch, and possibly mild dizziness or nausea related to vagus nerve stimulation.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have ongoing irregular heartbeats.

Select...

I am taking blood thinners and will continue during the study.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during 30 minutes of treatment or sham treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during 30 minutes of treatment or sham treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and during 30 minutes of treatment or sham treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Ventricular rate during taVNS application

Weekly ventricular rate

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active InterventionActive Control1 Intervention

Participants will self-administer active taVNS for 30 min per day for 7 days.

Group II: Sham InterventionPlacebo Group1 Intervention

Participants will self-administer sham-taVNS for 30 min per day for 7 days.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Burrell College of Osteopathic MedicineLead Sponsor

4 Previous Clinical Trials

266 Total Patients Enrolled

Harald M Stauss, MD, PhDPrincipal InvestigatorBurrell College of Osteopathic Medicine

3 Previous Clinical Trials

116 Total Patients Enrolled

Media Library

taVNS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05944575 — N/A

Atrial Fibrillation Research Study Groups: Sham Intervention, Active Intervention

Atrial Fibrillation Clinical Trial 2023: taVNS Highlights & Side Effects. Trial Name: NCT05944575 — N/A

taVNS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05944575 — N/A

Frequently Asked Questions

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

Are people with the specified condition currently being admitted to this experiment?

"According to clinicaltrials.gov, this medical experiment is not presently recruiting candidates. The trial was initially posted on August 7th 2023 and last updated July 12th of the same year. Despite that, there are 495 other studies actively enrolling people right now."

Answered by AI

Recent research and studies

JACC: Clinical ElectrophysiologyJournal

TREAT AF (transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation)

Stavrakis, Stavros, Julie A. Stoner, Mary Beth Humphrey, Lynsie Morris, Adrian Filiberti, Justin C. Reynolds, Khaled Elkholey, et al.. 2020. “TREAT AF (transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation)”. JACC: Clinical Electrophysiology. Elsevier BV. doi:10.1016/j.jacep.2019.11.008.

clinicaltrials.govStudy

Effect of taVNS on Heart Rate in Persistent Atrial Fibrillation

Harald Stauss MD PhD 2023. "Effect of taVNS on Heart Rate in Persistent Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05944575.