Safety and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1: A Double-blind, Randomized, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- maintenance of wakefulness test (MWT)
研究概览
简要总结
The study aimed to examine the efficacy and safety of tVNS as a complementary approach for NT1 by conducting a double-blind, randomized, sham-controlled trial. The specific objectives of the study were as follows: To evaluate the effects of complementary tVNS on the ability to maintain wakefulness, severity of narcolepsy, mood and quality of life in patients with NT1
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 12 years old with the ability to understand and complete the self-reported questionnaires
- •The patients met the international classification of sleep disorders third edition (ICSD-3) for NT126
- •Local residence for more than 3 months
- •Willingness to follow the trial plan as scheduled
排除标准
- •History of a clinically defined neurological or sleep disorders other than NT1
- •Any psychiatric disorder involving a history of psychosis
- •Any chronic condition affecting the ability to read or comprehend written instructions
- •Any substances abuse within the past 12 months
- •Pregnant or nursing
- •Metallic implants or devices contraindicating tVNS
研究组 & 干预措施
tVNS
transcutaneous vagus nerve stimulation on the left auricle with 25-Hz frequency, with a 30-second on/off cycle.
干预措施: transcutaneous auricular vagus nerve stimulation (Device)
Sham tVNS
transcutaneous vagus nerve stimulation on the left earlobe with 25-Hz frequency, with the same stimulation parameters
干预措施: transcutaneous auricular vagus nerve stimulation (Device)
结局指标
主要结局
maintenance of wakefulness test (MWT)
时间窗: 12 weeks
the changes in the maintenance of wakefulness test (MWT), mean sleep latency of the 4 MTW trials at baseline, week 4, week 8 and week 12, a clinical tool used to objectively measure the ability of patients with NT1 to maintain wakefulness and vigilance.
次要结局
未报告次要终点
研究者
Liu Yonghong
chief of neurology
Xijing Hospital