Recruiting

tVNS

Sponsor:

University of Oklahoma

Code:

NCT05172765

Conditions

Paroxysmal Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Electrical Nerve Stimulation Device

Study Details

Brief summary:

This proposal aims to determine the effects of tVNS on autonomic tone, atrial substrate and neuromodulators in patients with paroxysmal atrial fibrillation (AF), investigate the chronic effects of optimal tVNS on AF burden in patients with paroxysmal AF over a 6-month period, compared with sham stimulation, and identify physiological and biochemical markers of response to chronic tVNS.

Conditions

Paroxysmal Atrial Fibrillation

Study ID

NCT05172765

Start date

Sep 14, 2022

Status verified date

Mar, 2024

Completion date

May 29, 2026

Anticipated

Primary completion date

Oct 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Paroxysmal atrial fibrillation

Exclusion Criteria:

1. Sick sinus syndrome
2. 2nd and 3rd degree AV block (without pacemaker), bifascicular block or prolonged (PR>300ms) 1st degree AV block
3. History of vagotomy
4. Recurrent vasovagal syncope
5. Left ventricular ejection fraction < 40%
6. Significant valvular disorder (i.e., prosthetic valve or hemodynamic significant valvular diseases)
7. Recent stroke (< 3 months)
8. Myocardial infarction or hospitalization for heart failure (< 3 months)
9. Severe heart failure (NYHA Class IV)
10. End stage kidney disease on dialysis
11. Pregnancy

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active TENS Stimulation

sham comparator: Inactive TENS Stimulation

Interventions

Transcutaneous Electrical Nerve Stimulation Device

Low-level, electrical stimulation of the outer ear (LLTS), using a transcutaneous electrical nerve stimulation (TENS) device.

Primary outcome measure

  • Effects of tVNS on Atrial fibrillation burden [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Natalia Wells-Serrano

405-271-4742Natalia-WellsSerrano@ouhsc.edu

Locations

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Stavros Stavrakis, MD

405-271-9696Stavros-Stavrakis@ouhsc.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Mar 6, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2024-03-06.