Clinical Trial: Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents
Brief Summary:
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
Detailed Summary:
Sponsor: University Hospital, Akershus
Current Primary Outcome:
- Fatigue [ Time Frame: 6 monhts ]Chalder fatigue questionnaire, total score
- Steps per day [ Time Frame: 6 monhts ]Mean number of steps/day across 7 consecutive days, measured by accelerometer (ActivePal)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pain threshold [ Time Frame: 6 monhts ]Assessed by pressure algometry
- Autonomic cardiovascular control [ Time Frame: 6 monhts ]Assessed by noninvasive, continuous recordings of heart rate, blood pressures and stroke volume during supine rest.
- Cognitive function [ Time Frame: 6 monhts ]Assessed by the instruments WISC-IV, D-KEFS, HVLT-R and WASI.
- Neuroendocrine markers [ Time Frame: 6 monhts ]In particular blood and urine measurements of catecholamines and the HPA axis
- Immune markers [ Time Frame: 6 monhts ]In particular blood measurements of cytokines
- Bodily symptoms [ Time Frame: 6 monhts ]Assessed by different questionnaires
- Quality of life [ Time Frame: 6 monhts ]Assessed by the PedsQL inventory
- Functional disability [ Time Frame: 6 monhts ]Assessed by the FDI inventory
Original Secondary Outcome: Same as current
Information By: University Hospital, Akershus
Dates:
Date Received: January 7, 2015
Date Started: March 2015
Date Completion: October 2018
Last Updated: January 26, 2017
Last Verified: January 2017