Effects of Vagus Nerve Stimulation in Post-COVID-19 Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Heart Rate Variability
研究概览
简要总结
The aim of this study is to increase parasympathetic activity and decrease the severity of symptoms by providing vagal stimulation with the t-VNS method in order to suppress the increased sympathetic activity in patients with prolonged Covid symptoms.The main question[s] it aims to answer are:
Question 1:Is left ear transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in Post Covid syndrome?
Question 2:Is bilateral auricular transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in Post Covid syndrome?
A 5-minute heart rate variability measurement will be performed to measure the effectiveness of vagus nerve stimulation in participants.HRV is a non-invasive method used to evaluate ANS activity and is a measure of heart rate change over a period of time
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being 18 years or older
- •Experiencing at least one of the post-covid symptoms for 12 weeks or longer
排除标准
- •Considering that the female reproductive hormones level in the body and menstrual cycle may affect the ANS in female patients, female participants in perimenopausal, post-menopausal and pregnancy conditions were excluded from the study.
- •Participants who used medication for the treatment of ANS dysfunction in the last six months were also excluded from the study.
结局指标
主要结局
Heart Rate Variability
时间窗: After the evaluation of the patients on the first day of participation in the study, the final evaluation was completed at the end of the 10th session (10 days later).
HRV is a non-invasive method used to evaluate ANS activity and is a measure of heart rate change over a period of time. It analyzes the change in the beat-beat intervals of the heart and reflects the balance between PNS and SNS. During the analysis of heart rate variability measurement, the results obtained from sub-parameters such as stress index, time-domain and frequency-domain measurements allow evaluation of PNS and SNS activity.
次要结局
- Fatigue Severity Scale(After the evaluation of the patients on the first day of participation in the study, the final evaluation was completed at the end of the 10th session (10 days later).)
研究者
Alper Percin
Lecturer
Bahçeşehir University