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NCT Number: NCT02335437

Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents

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

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Key information

Conditions

Fatigue Syndrome, Chronic Chronic Disease DNA Virus Infections Disease Attributes Encephalomyelitis Epstein-Barr Virus Infections Herpesviridae Infections Infections Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tumor Virus Infections Virus Diseases

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Pediatrics, Akershus University Hospital

Lørenskog, Akershus, N-1478, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fatigue

    Time frame: 6 monhts

    Chalder fatigue questionnaire, total score

  2. Steps per day

    Time frame: 6 monhts

    Mean number of steps/day across 7 consecutive days, measured by accelerometer (ActivePal)

Secondary outcomes

  1. Pain threshold

    Time frame: 6 monhts

    Assessed by pressure algometry

  2. Autonomic cardiovascular control

    Time frame: 6 monhts

    Assessed by noninvasive, continuous recordings of heart rate, blood pressures and stroke volume during supine rest.

  3. Cognitive function

    Time frame: 6 monhts

    Assessed by the instruments WISC-IV, D-KEFS, HVLT-R and WASI.

  4. Neuroendocrine markers

    Time frame: 6 monhts

    In particular blood and urine measurements of catecholamines and the HPA axis

  5. Immune markers

    Time frame: 6 monhts

    In particular blood measurements of cytokines

  6. Bodily symptoms

    Time frame: 6 monhts

    Assessed by different questionnaires

  7. Quality of life

    Time frame: 6 monhts

    Assessed by the PedsQL inventory

  8. Functional disability

    Time frame: 6 monhts

    Assessed by the FDI inventory

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Acronym: CEBA

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jan 9, 2015
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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