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