Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-29 @ 3:01 AM
Study NCT ID:
NCT07093034
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-16
First Post:
2025-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sustained Auricular Nerve Stimulation for PVC Suppression
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
Sustained Auricular Nerve Stimulation for PVC Suppression
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SANS-PVC
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: