Clinical Study of Transcranial Alternating Current Stimulation in the Prevention of Delirium in Patients With Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Incidence of delirium
研究概览
简要总结
The goal of this clinical trial is to learn about using the latest transcranial alternating current stimulation (tACS) to reduce the incidence of delirium in patients with subarachnoid hemorrhage. The main question it aims to answer is:
• To evaluate the effect of tACS on reducing delirium in patients with subarachnoid hemorrhage.
Participants will treated with real tACS or sham tACS. Researchers will mainly compare the two groups to see if patients' delirium will reduce by using tACS.
详细描述
Research objectives: To reduce the incidence of delirium in patients with subarachnoid hemorrhage by using the latest transcranial alternating current stimulation.
Research contents:
- To evaluate the effect of transcranial alternating current stimulation on improving sleep quality in patients with subarachnoid hemorrhage;
- To evaluate the effect of transcranial alternating current stimulation on reducing delirium in patients with subarachnoid hemorrhage.
Research hypothesis: Transcranial alternating current stimulation can improve sleep quality and reduce the incidence of delirium in patients with subarachnoid hemorrhage.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The random number table method was used for randomization, and the envelope method was used for randomization. The random serial number was stored in an airtight envelope, an envelope was opened when a patient was admitted.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subarachnoid hemorrhage was consistent with the Chinese Guidelines for the Diagnosis and Treatment of Subarachnoid Hemorrhage 2015;
- •Patients after completion of surgical treatment;
- •over 18 years of age;
- •Hunt & Hess grade I-III;
- •No major organ failure;
- •The patient has no speech or hearing impairment;
- •Informed consent of patients and their families, signed informed consent.
排除标准
- •Those who have delirium at the time of enrollment;
- •had substance abuse/dependence within 6 months before enrollment;
- •had suffered from other mental illness within 6 months before enrollment;
- •Suffering from serious or unstable organic diseases;
- •Pregnant or lactating women and those planning to become pregnant in the near future;
- •Damaged skin integrity at the electrode placement site, allergic to electrode gels or adhesives.
- •with an implanted electronic stimulator;
- •Patients who had received other noninvasive neuromodulation therapy within 1 month before enrollment;
- •Participants in any other clinical trial within 1 month prior to baseline;
- •There are circumstances in which the researcher considers it inappropriate to participate in this study.
结局指标
主要结局
Incidence of delirium
时间窗: up to 5days
(occurrence of delirium was assessed 3 times a day from the start of the intervention to the day after the intervention ended ) Delirium incidence = Number of people who had experienced delirium within 5 days/total number of people in the intervention or control group.
次要结局
- Anxiety score(up to 5days)
- Duration of delirium(up to 5days)
- Sleep quality score(up to 5days)
- Cognitive function score(up to 5days)