NCT04622748Unknown不适用
An Investigation of Neurocognitive Functions and the Influencing Factors in Recovered Patients With COVID-19
National Institute on Drug Dependence, China1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年7月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Cognitive flexibility
研究概览
简要总结
This study is carried on in Wuchang Hospital in Wuhan, China. The investigators plan to recruit 80 patients with COVID-19 and 80 matched healthy control. Using the design of case-control study, the study aims to assess the neurocognitive functions such as executive function and attentional bias in recovered patients with COVID-19 under normal and stress conditions, and to analyze the influencing factors of neurocognitive functions, such as mental health conditions, inflammation indicators and cardiopulmonary function.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recovered COVID-19 patients or uninfected residents in Wuhan, with an education level above elementary school and are able to complete cognitive tasks;
- •Willing to participate in this study and sign informed consent.
排除标准
- •Subjects with body temperature> 38°C;
- •Subjects who are in menstruation and pregnancy;
- •Subjects suffering from cardiopulmonary diseases before the new coronary pneumonia epidemic (such as heart disease, pulmonary hypertension, congestive heart failure, etc.);
- •Subjects with severe disturbances in consciousness, cognitive dysfunction, mental disorders, visual and hearing disorders, bone and joint diseases, etc.;
- •Subjects with abnormal immune system and severe organ dysfunction (heart, liver, kidney, etc.);
- •Subjects who are unwilling to participate in this study and cannot complete all surveys and cognitive function tests.
结局指标
主要结局
Cognitive flexibility
时间窗: 3 minutes
assessed by the trail-making task
working memory
时间窗: 10 minutes
assessed by the n-back task, including 0-back, 1-back and 2-back
Inhibitory control
时间窗: 10 minutes
assessed by the stroop task
次要结局
- Sleep(3-5 minutes)
- CRP(1 day)
- Cardiopulmonary function 2(10 minutes)
- Attention Bias(15 minutes)
- Anxiety(3-5 minutes)
- Serum TNFalpha(1 day)
- Serum IL-6(1 day)
- PTSD(3-5 minutes)
- Cardiopulmonary function 1(15 minutes)
- Depression(3-5 minutes)
- General cognition(8-10 minutes)
研究者
研究点 (1)
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