Sustained Auricular Nerve Stimulation for PVC Suppression

Not Applicable

• Conditions: Premature Ventricular Complexes; PVC - Premature Ventricular Contraction; Auricular Vagus Nerve Stimulation

• Registration Number: NCT07093034
• Lead Sponsor: University of California, San Diego

Brief Summary

Non-invasive vagus nerve stimulation has been clinically tested for the treatment cardiac arrhythmias. However, prior studies have shown mixed results-possibly in part due to inadequate stimulation duration. Therefore, we have designed an investigator-initiated early feasibility study to evaluate safety, tolerability, and compliance with prolonged, nocturnal auricular nerve stimulation using the Parasym device.

Detailed Description

The study will utilize the Parasym transcutaneous auricular vagal nerve stimulation device. This small, battery-powered device delivers electrical stimulation through an ear clip attached to the tragus. Participants will self-administer the stimulation once daily, at bedtime, for 6 continuous hours. The device has two settings to facilitate our RCT: active treatment and sham control. After one month in the first treatment arm, participants will be crossed over to the other arm of the study. Participants and outcome assessors will be blinded to the allocation. The primary outcomes will be assessed via standardized questionnaires administered by blinded outcome assessors. The secondary outcome of PVC burden will be assessed by non-invasive event monitors.

Study Timeline

• Study Start: 2025-07-01
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-07-28
• Study First Posted: 2025-07-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-08
• Last Update Posted: 2025-08-14
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Quality of Life	10 weeks	Participants will rate quality of life at multiple pre-specified time points throughout the study
Tolerability	10 weeks	Participants will rate tolerability of wearing the device at night at multiple pre-specified time points throughout the study
Safety	10 weeks (duration of entire study)	The occurrence of adverse events (AEs) throughout the study.
Feasibility	10 weeks	Participants will rate ease of wearing the device at night at multiple pre-specified time points throughout the study

Secondary Outcome Measures

Name	Time	Method
PVC burden	10 weeks	PVC burden will be tracked by event monitoring at pre-specified time points throughout the study

Trial Locations

Locations (1)

UC San Diego Health System; 🇺🇸 La Jolla, California, United States