Sustained Auricular Nerve Stimulation for PVC Suppression (SANS-PVC)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Individuals must meet all of the following inclusion criteria to be eligible to participate in this study:
Age ≥ 18 years
PVC burden ≥ 5% documented on an event monitor or implanted cardiac device
Provide written informed consent
Willingness to comply with all study procedures
Availability for the duration of the study (10 weeks)
Individuals meeting any of the following exclusion criteria at baseline will be excluded from study participation:
Unwilling or unable to provide informed consent for oneself
Last available left ventricular ejection fraction < 20%
NYHA Class IV symptoms
Acute coronary syndrome within two weeks of randomization
Active pregnancy or breastfeeding
Intention to become pregnant
Statement Regarding Equitable Selection:
This study will not exclude specific populations based on age, sex, race, or ethnicity. The inclusion/exclusion criteria are based on clinical factors relevant to the study intervention and the safety of participants. Limited English proficiency will not be an exclusion criterion, and appropriate translation services will be provided to ensure informed consent and understanding of study procedures.
Trial design
Primary purpose
Allocation
Interventional model
Masking
16 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal