Trials / Enrolling By Invitation
Enrolling By InvitationNCT07093034
Sustained Auricular Nerve Stimulation for PVC Suppression
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- Sponsor
- University of California, San Diego · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Premature Ventricular Complexes
- PVC - Premature Ventricular Contraction
- Auricular Vagus Nerve Stimulation
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Extended nocturnal use of auricular vagus nerve stimulator device | Patients will wear the ParasymTM device with an ear clip on the tragus that provides stimulation at sub-detection threshold. |
Timeline
- Start date
- 2025-07-01
- Primary completion
- 2026-03-01
- Completion
- 2026-05-31
- First posted
- 2025-07-30
- Last updated
- 2025-10-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07093034. Inclusion in this directory is not an endorsement.