MedTrace Logo

Effect of taVNS on Heart Rate in Persistent Atrial Fibrillation

NCT05944575 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-07-14

No results posted yet for this study

Summary

The goal of this clinical trial is to investigate the effects of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) in patients with persistent atrial fibrillation. taVNS is a treatment through which a small electrical current is applied to a specific location of the left ear. The main question to answer is whether taVNS will reduce the heart rate in patients with persistent atrial fibrillation. After appropriate training, participants will self-administer taVNS for 30 minutes every day for two weeks. During one of the two weeks (randomized order), the clip electrode, delivering the electrical current will be attached to the cymba conchae of the left ear, while during the other week the clip electrode will be attached to the lobule of the left ear. During both weeks, the electrocardiogram (ECG) will be monitored continuously through a small ECG patch that is placed on the chest. Participants will meet with the investigators at the beginning of the study, after 7 days and at the end of the study (after 14 days). Researchers will compare the ECG obtained during the two weeks and evaluate if the heart rate differs between the two study weeks.

Conditions

  • Atrial Fibrillation, Persistent

Interventions

DEVICE

active taVNS

The clip electrode will be attached to the cymba conchae of the left ear, the location of the auricular branch of the vagus nerve.

DEVICE

sham-taVNS

The clip electrode will be attached to the lobule of the left ear that is not innervated by the auricular branch of the vagus nerve.

Sponsors & Collaborators

  • Burrell College of Osteopathic Medicine

    lead OTHER

Principal Investigators

  • Harald M Stauss, MD, PhD · Burrell College of Osteopathic Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-07
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05944575 on ClinicalTrials.gov