A Randomized, Sham-controlled Pilot Trial of a Novel Therapeutic Strategy (taVNS) for Autonomic Nervous System (ANS) Dysfunction in Chronic Kidney Disease (CKD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of Patients who Complete 2 Weeks of Intervention
研究概览
简要总结
30 patients will participate in a prospective randomized clinical trial to test the safety, tolerability and efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) for autonomic nervous system (ANS) dysfunction in the chronic kidney disease (CKD) stage 3-5 setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 age ≥18 years
- •Diagnosis of Chronic Kidney Disease (CKD) stage 3-5 [estimated glomerular filtration rate ≤60 mL/min/1.73m2]
- •Receiving care at NYU Nephrology outpatient practice
- •Able to provide informed consent
排除标准
- •Primary ANS disorders (e.g., Parkinson's disease)
- •Arrhythmias
- •Implantable cardioverter-defibrillator (ICD) or pacemaker (PPM) precluding assessment of HRV (e.g., chronic atrial fibrillation)
- •On maintenance dialysis (HD)
- •Symptomatic bradycardia
- •Presence of an implantable defibrillators
- •Presence of a permanent pacemaker
- •Unable to consent
- •Incarcerated individuals
- •Pregnant individuals
研究组 & 干预措施
Active taVNS
Participants receive two weeks of 15-minute taVNS daily in the morning.
干预措施: Active taVNS (Device)
Sham taVNS
Participants receive two weeks of 15-minute sham intervention daily in the morning.
干预措施: Sham taVNS (Device)
结局指标
主要结局
Proportion of Patients who Complete 2 Weeks of Intervention
时间窗: Week 2
Proportion of patients who use the device for 2 weeks (14 sessions). Measure of feasibility.
Proportion of Patients who Tolerate Each Full 15-Minute Session
时间窗: Week 2
Proportion of patients who use the device for 2 weeks (14 sessions), 15 minutes per session. Measure of feasibility
Incidence of Severe Bradycardia following taVNS Use
时间窗: Up to Week 2
Severe bradycardia defined as heart rate (HR) \<50 beats per minute. Measure of safety.
Incidence of Severe Tachycardia following taVNS Use
时间窗: Up to Week 2
Severe tachycardia defined as heart rate (HR) \>100 beats per minute. Measure of safety.
Incidence of Syncope following taVNS Use
时间窗: Up to Week 2
Measure of safety.
次要结局
- Proportion of eligible patients who consent to use the device for 2 weeks(Up to Week 2)
- Change in High Frequency (HF) Signal from Baseline(Baseline, Week 2)