Effect of taVNS on Heart Rate in Persistent Atrial Fibrillation

NCT05944575 | Unknown FDA Device

• 1 other identifier: 0104_2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vagus nerve stimulation; Electrocardiogram; Heart rate

Outcome Measures

Primary Outcomes (2)

• Weekly ventricular rate

  The average ventricular rate (obtained from the ECG patch) during the week with active taVNS (active intervention arm) will be compared with the average ventricular rate during the week with sham-taVNS (sham intervention arm).

  After one week of treatment or sham treatment

• Ventricular rate during taVNS application

  The ventricular rate (obtained from the ECG patch) during the 30 min of taVNS application will be compared with the ventricular rate during the 30 min of sham-taVNS application for each of the 7 days of each study arm.

  During 30 minutes of treatment or sham treatment

Study Arms (2)

Active Intervention

ACTIVE COMPARATOR

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

Device: active taVNS

Sham Intervention

SHAM COMPARATOR

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

Device: sham-taVNS

Interventions

active taVNS DEVICE

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

Active Intervention

sham-taVNS DEVICE

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.

Sham Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Persistent atrial fibrillation
• On anti-coagulation throughout the study

You may not qualify if:

• Below 18 years of age
• Pregnancy
• Signs or history of vestibulocochlear neuronitis or nerve damage (e.g., hearing loss or tinnitus)
• Signs or history of epilepsy
• Not on anti-coagulation

Sponsors & Collaborators

• Burrell College of Osteopathic Medicine: lead

Study Sites (1)

Burrell College of Osteopathic Medicine

Las Cruces, New Mexico, 88001, United States

Location

Related Publications (2)

• Dalgleish AS, Kania AM, Stauss HM, Jelen AZ. Occipitoatlantal decompression and noninvasive vagus nerve stimulation slow conduction velocity through the atrioventricular node in healthy participants. J Osteopath Med. 2021 Feb 18;121(4):349-359. doi: 10.1515/jom-2020-0213.

  PMID: 33694346 BACKGROUND

• Stavrakis S, Stoner JA, Humphrey MB, Morris L, Filiberti A, Reynolds JC, Elkholey K, Javed I, Twidale N, Riha P, Varahan S, Scherlag BJ, Jackman WM, Dasari TW, Po SS. TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial. JACC Clin Electrophysiol. 2020 Mar;6(3):282-291. doi: 10.1016/j.jacep.2019.11.008. Epub 2020 Jan 29.

  PMID: 32192678 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Harald M Stauss, MD, PhD

  Burrell College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harald M Stauss, MD, PhD

CONTACT

575-674-2327; hstauss@burrell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told if the location of the clip electrode will be for active taVNS or for sham-taVNS.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacology

Model Details: Treatment for each patient will crossover (after one week) from an active taVNS to an inactive sham-taVNS treatment or vice versa (depending on randomization).

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 13, 2023
• Study Start: August 7, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)