Clinical Study on the Effect of Improving Sleep Quality on Cognitive Function in Patients With Epilepsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment
研究概览
简要总结
Epilepsy is one of the common chronic diseases of the central nervous system. 30% to 40% of patients with epilepsy have varying degrees of cognitive impairment, which affects their quality of life. At present, the treatment of cognitive impairment in patients with epilepsy is relatively scarce, and the therapeutic effect is still not ideal. Recent studies have shown that sleep disorder is also an important factor causing cognitive dysfunction, and improving sleep quality has a prospect to become a new way to treat cognitive impairment in patients with epilepsy. The purpose of this study is to observe the relationship between sleep and cognitive function in patients with epilepsy, and to improve the sleep quality of patients with epilepsy, so as to provide new ideas for improving cognitive impairment in patients with epilepsy.
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
- 7 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In accordance with the diagnostic criteria of epilepsy;
- •History of epilepsy ≥ 1 year;
- •Epilepsy with cognitive impairment;
- •Age 7-65 years old;
- •There was no change in the type and dose of antiepileptic drugs during the experiment;
- •Patients and their families were aware of this study and signed an informed consent form.
排除标准
- •Status epilepticus;
- •Complicated with severe infection, cerebrovascular diseases, malignant tumors, other nervous system diseases, and systemic diseases that can involve the nervous system (such as immune diseases, etc.), serious dysfunction of heart, liver, kidney and other organs;
- •Non-epileptic seizures such as syncope and hysteria;
- •Women during lactation or pregnancy;
- •Combined use of sleeping and sedative drugs;
- •There are contraindications of melatonin and percutaneous vagal nerve stimulation (tVNS).
研究组 & 干预措施
Melatonin Tablets
干预措施: Melatonin Tablets (Other)
Lactasin Tablets
干预措施: Lactasin Tablets (Other)
transcutaneous vagus nerve stimulation
干预措施: transcutaneous vagus nerve stimulation (Device)
sham transcutaneous vagus nerve stimulation
干预措施: sham transcutaneous vagus nerve stimulation (Device)
结局指标
主要结局
Montreal Cognitive Assessment
时间窗: Week 4
The difference between the end of treatment score and the baseline
次要结局
- Pittsburgh sleep quality index(Week 4)
- Rey auditory verbal learning test(Week 4)
- Quality of life questionnaire in epilepsy inventory(Week 4)
- Rey complex figure test(Week 4)
- Boston naming test(Week 4)
- Wechsler Memory Scale(Week 4)