CEBA: Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents

Sponsor

University Hospital, Akershus (Other)

Overall Status

Completed

CT.gov ID

NCT02335437

Collaborator

(none)

270

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Fatigue Syndrome, Chronic Epstein-Barr Virus Infections

Study Design

Study Type:

Observational

Anticipated Enrollment :

270 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Acute EBV infection
Healthy controls

Outcome Measures

Primary Outcome Measures

Fatigue [6 monhts]
Chalder fatigue questionnaire, total score
Steps per day [6 monhts]
Mean number of steps/day across 7 consecutive days, measured by accelerometer (ActivePal)

Secondary Outcome Measures

Pain threshold [6 monhts]
Assessed by pressure algometry
Autonomic cardiovascular control [6 monhts]
Assessed by noninvasive, continuous recordings of heart rate, blood pressures and stroke volume during supine rest.
Cognitive function [6 monhts]
Assessed by the instruments WISC-IV, D-KEFS, HVLT-R and WASI.
Neuroendocrine markers [6 monhts]
In particular blood and urine measurements of catecholamines and the HPA axis
Immune markers [6 monhts]
In particular blood measurements of cytokines
Bodily symptoms [6 monhts]
Assessed by different questionnaires
Quality of life [6 monhts]
Assessed by the PedsQL inventory
Functional disability [6 monhts]
Assessed by the FDI inventory

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Medical treatment for another disease (hormonal conterception and antibiotics against tonsillitis/pharyngitis are accepted)
Pregnancy
Debut of illness > 6 weeks ago