Auricular Vagus Nerve Stimulation, Premature Ventricular Complexes, PVC - Premature Ventricular Contraction
Conditions
Keywords
auricular vagus nerve stimulation, parasym, premature ventricular contractions (PVCs), Non-invasive neuromodulation, Cardiac arrhythmia, autonomic nervous system modulation, Trancutaneous electrical stimulation, Randomized controlled trial, heart rate variability, feasibility study
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.
Interventions
DEVICEExtended 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.
Sponsors
University of California, San Diego
Parasym Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 10 weeks (duration of entire study) | The occurrence of adverse events (AEs) throughout the study - including major, minor, severe adverse events and whether they lead to discontinuation of the device |
| Tolerability | 10 weeks | Participants will rate tolerability of wearing the device at night at multiple pre-specified time points throughout the study |
| Quality of Life | 10 weeks | Participants will rate quality of life at multiple pre-specified time points 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
| Measure | Time frame | Description |
|---|---|---|
| PVC burden | 10 weeks | PVC burden will be tracked by event monitoring at pre-specified time points throughout the study |
Countries
United States
Outcome results
None listed