NCT02335437已完成不适用
Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents
University Hospital, Akershus1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2015年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Fatigue
研究概览
简要总结
Chronic fatigue syndrome (CFS) is characterized by unexplained, disabling and long lasting fatigue, as well as pain, impaired memory, sleep difficulties and other symptoms. Epstein-Barr virus (EBV) infection might precipitate CFS. In this study, 200 adolescents undergoing acute EBV infection will be followed prospectively, and also compared with a group of healthy controls. The aim is twofold:
- To identify factors that predispose to chronic fatigue among adolescents with acute EBV infection
- To compare pathophysiological features of patients with acute EBV infection with a group of healthy controls.
Possible risk factors for chronic fatigue 6 months after EBV-infection includes:
- Severity of the initial infection
- Immune responses characteristics
- Characteristics of the neuroendocrine stress response
- Cognitive functioning
- Emotional disturbances
- Genetics/ epigenetics of candidate genes
- Certain personality traits
- Critical life events
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 12 years and < 20 years
- •Serological confirmation of acute EBV infection
- •Lives in one of the following Norwegian counties: Oslo, Akershus, Buskerud, Østfold, Vestfold
排除标准
- •Medical treatment for another disease (hormonal conterception and antibiotics against tonsillitis/pharyngitis are accepted)
- •Pregnancy
- •Debut of illness > 6 weeks ago
结局指标
主要结局
Fatigue
时间窗: 6 monhts
Chalder fatigue questionnaire, total score
Steps per day
时间窗: 6 monhts
Mean number of steps/day across 7 consecutive days, measured by accelerometer (ActivePal)
次要结局
- Bodily symptoms(6 monhts)
- Pain threshold(6 monhts)
- Autonomic cardiovascular control(6 monhts)
- Cognitive function(6 monhts)
- Functional disability(6 monhts)
- Neuroendocrine markers(6 monhts)
- Immune markers(6 monhts)
- Quality of life(6 monhts)
研究者
Vegard Bruun Wyller, MD, PhD
Professor
University Hospital, Akershus
研究点 (1)
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