Sustained Auricular Nerve Stimulation for PVC Suppression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Quality of Life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Arm 1: Active stimulation followed by crossover to Sham stimulation
干预措施: Extended nocturnal use of auricular vagus nerve stimulator device (Device)
Arm 2: Sham stimulation followed by crossover to Active stimulation
干预措施: Extended nocturnal use of auricular vagus nerve stimulator device (Device)
结局指标
主要结局
Quality of Life
时间窗: 10 weeks
Participants will rate quality of life at multiple pre-specified time points throughout the study
Tolerability
时间窗: 10 weeks
Participants will rate tolerability of wearing the device at night at multiple pre-specified time points throughout the study
Safety
时间窗: 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
Feasibility
时间窗: 10 weeks
Participants will rate ease of wearing the device at night at multiple pre-specified time points throughout the study
次要结局
- PVC burden(10 weeks)
研究者
Ulrika Birgersdotter-Green
Professor of Medicine
University of California, San Diego