Sustained Auricular Nerve Stimulation for PVC Suppression

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07093034
Status
Enrolling By Invitation

Conditions

  • Auricular Vagus Nerve Stimulation
  • PVC - Premature Ventricular Contraction
  • Premature Ventricular Complexes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Extended nocturnal use of auricular vagus nerve stimulator device — DEVICE
    Patients will wear the ParasymTM device with an ear clip on the tragus that provides stimulation at sub-detection threshold.

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Aug 2025
Primary completion
Mar 1, 2026
Completion
May 31, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Active stimulation followed by crossover to Sham stimulation
  • Experimental: Arm 2: Sham stimulation followed by crossover to Active stimulation

Primary Outcome Measure

Safety [ Time Frame: 10 weeks (duration of entire study) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC San Diego Health SystemLa JollaCalifornia92037-

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UC San Diego Health System· La Jolla, CA

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