Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial Fibrillation (BiG tVNS-AF)

This study is testing a device called Transcutaneous Electrical Nerve Stimulation (tVNS) for people with paroxysmal atrial fibrillation (AF), which is an irregular heartbeat that comes and goes. The researchers want to see how tVNS, which uses low-level electrical stimulation on the outer ear, affects AF over six months. They are also looking for signs in the body that show who might respond best to this treatment. You may be able to join if you are between 21 and 90 years old and have paroxysmal AF. The study is looking for 160 participants, but the current recruitment status is unclear.

Study design
This interventional study involves randomizing participants to different stimulation frequencies and intensities to find the optimal settings for tVNS. A subgroup of participants undergoing AF ablation will also be randomized to active or sham tVNS.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures the effects of tVNS on Atrial Fibrillation burden at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05172765

Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)

UNKNOWN
NAAges 21–90InterventionalTreatment
University of Oklahoma
~160 participants
Updated 2024-03-06 on ClinicalTrials.gov
What's tested:Transcutaneous Electrical Nerve Stimulation Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effects of tVNS on Atrial fibrillation burden
Measured over 6 months
Paroxysmal Atrial Fibrillation

NCT05172765

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahomastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Stavros Stavrakis, MD · PRINCIPAL_INVESTIGATOR · University of Oklahoma

Opens a ready-to-send draft in your own email app — review before sending.

  • Effects of tVNS on Atrial fibrillation burden6 months

    AF burden, defined as the percent of time spent in AF over the total monitoring period, will be determined be based on continuous monitoring with an Apple watch