Fatigue Post ViralMAP-FATNCT07394855
Mechanisms of Persistent Fatigue
An observational study of Fatigue Post Viral, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
Persistent fatigue (PF) is a common symptom across countries and cultures, and an important cause of disability and reduced quality of life. Acute infection is a common trigger of PF, as exemplified by the 'Long COVID' phenomenon. Read more about this study
- Who is it for?
- Ages 16 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue Post Viral
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 28 Apr 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 39 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The population served by the South-Eastern Norway Regional Health Authority (approximately 3.1M)
Who may be able to join
- EBV infection, laboratory confirmed.
- First symptoms > 3 and < 6 weeks away
Who cannot join
- Co-morbidity, including mental illness (seasonal allergy/asthma is accepted if no signs/symptoms)
- Usage of pharmaceuticals (hormonal contraception and paracetamol/ibuprofen is accepted)
- Concurrent demanding life event causing fatigue.
- Disability impacting on daily living.
- Regular smoking
- Usage of illicit drugs
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Akershus University Hospital
Lørenskog, N-1478
Director of Dept. of Paeditrics and Adolescent Medicine, 4767960000, postmottak@ahus.no
About this study
Official title: Mechanisms of Persistent Fatigue (MAP-FAT): A Prospective Observational Cohort Study of Persistent Fatigue Following Epstein-Barr Virus Infection in Adolescents and Young Adults
Persistent fatigue (PF) is a common symptom across countries and cultures, and an important cause of disability and reduced quality of life. Acute infection is a common trigger of PF, as exemplified by the 'Long COVID' phenomenon. Despite substantial burden for the suffering individuals as well as their next-of-kins, the healthcare systems and the economy, PF is an under-researched field, with scarce knowledge of disease mechanisms as well as treatment and preventive measures.
Existing knowledge on PF suggests complex interactions between functional brain processes (as opposed to permanent brain damage), aberrations of the immune system (that normally protects against infection) and the autonomic (or non-voluntary) part of the nervous system (that monitors the internal state of the body and adjusts the function of internal organs). Previous findings have been interpreted in light of two alternative models: A body-to-brain mechanism where disturbances of the immune system are thought to impact on brain functions, and a brain-to-body mechanism where functional brain alteration is regarded the central element whereas aberration of the immune system is seen as a consequence (rather than a cause) mediated through altered activity of the autonomic nervous system.
The multinational and collaborative Mechanism of Persistent Fatigue (MAP-FAT) project is determined to scrutinize both these potential brain-body interactions in PF. The main objectives are: a) To determine the relationship between PF, activities in certain brain areas, activity in a certain part of the autonomic nervous system (the sympathetic branch), and immunological alterations; b) To determine whether PF is primarily dependent upon the brain's automatic predictions rather than the continuous sensory information mediated to the brain. To achieve these objectives, MAP-FAT will exploit an existing health registry on post-infective fatigue (preparatory part) and conduct a new post-infective cohort study (main part) in which a total of 150 individuals with "kissing disease" and 150 healthy controls are followed for six months. Investigations include: a) Clinical and demographic assessment; b) Questionnaire charting; c) Functional and structural imaging of the brain (multimodal brain MRI); d) Assessment of autonomic nervous system activity; e) Deep immunological profiling; and f) Behavioral experiments. The latter are specifically designed to disentangle the relative contributions of the brain's automatic predictions and sensory input for the experience of PF. In addition, one of the experiments includes concurrent functional brain imaging, autonomic nervous system assessment, and immunological profiling during experimental injections of drugs that impact on autonomic activity; this experiment is key for addressing the causal association between brain functions, autonomic activity and immunological disturbance.
- Conditions
- Fatigue Post Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EBV | Individuals with acute Epstein-Barr virus infection | |
| HC | Healthy control individuals (ie., no acute EBV infection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASP difference
The difference in symptom ratings between neutral and negative affect provoking pictures during the Affect and Symptom Paradigm (ASP)
Measured: At six months' follow-up
Secondary outcomes (3)
VHBP regression ratio
Ratio between the regression coefficient for exerted power vs. fatigue (an index of interoceptive input) and the regression coefficient for virtual hill gradient vs. fatigue (an index of prior expectations) during the Virtual Hill Bicycling Paradigm (VHBP)
Measured: At six months' follow-up
INSULA connectivity
Functional connectivity characteristics of the Insula cortical brain region
Measured: At six months' follow-up
FATIGUE CFQ
Fatigue scores (sum score from the Chalder Fatigue Questionnaire (CFQ), where higher values means more fatigue).
Measured: At six months' follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start28 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue Post ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vegard Wyller, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394855
- Sponsor's protocol ID
- AHUS p360 26/01004
- Acronym
- MAP-FAT
- Status last verified
- May 2026
- First submitted
- 31 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized IPD from all elements of MAP-FAT will be shared at a trusted, public repository such as ZENODO. We will adhere to the FAIR (findable, accessible, interoperable, reusable) principles: * A unique and persistent Digital Object Identifier (DOI) will be assigned to each item in the public repository, thus making them easily findable. * MAP-FAT (meta)data will be retrievable by its identifier; all beneficiaries will ensure open access to the deposited data, following the principle 'as open as possible as closed as necessary'. * MAP-FAT (meta)data will use a formal, accessible, shared, and broadly applicable language for knowledge representation. Interoperability resources such as FAIRsharing will be applied. * The conditions under which the data can be used will be made transparent through easy-to-use copyright licenses, such as Creative Commons (Creative Commons Attribution International Public License, CC BY) or Creative Commons Public Domain Dedication (CC 0).
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Persistent Fatigue (MAP-FAT): A Prospective Observational Cohort Study of Persistent Fatigue Following Epstein-Barr Virus Infection in Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT07394855
- Acronym / sponsor ID
- MAP-FAT / AHUS p360 26/01004
- Conditions
- Fatigue Post Viral
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Persistent fatigue (PF) is a common symptom across countries and cultures, and an important cause of disability and reduced quality of life. Acute infection is a common trigger of PF, as exemplified by the 'Long COVID' phenomenon. Despite substantial burden for the suffering individuals as well as their next-of-kins, the healthcare systems and the economy, PF is an under-researched field, with scarce knowledge of disease mechanisms as well as treatment and preventive measures.
Existing knowledge on PF suggests complex interactions between functional brain processes (as opposed to permanent brain damage), aberrations of the immune system (that normally protects against infection) and the autonomic (or non-voluntary) part of the nervous system (that monitors the internal state of the body and adjusts the function of internal organs). Previous findings have been interpreted in light of two alternative models: A body-to-brain mechanism where disturbances of the immune system are thought to impact on brain functions, and a brain-to-body mechanism where functional brain alteration is regarded the central element whereas aberration of the immune system is seen as a consequence (rather than a cause) mediated through altered activity of the autonomic nervous system.
The multinational and collaborative Mechanism of Persistent Fatigue (MAP-FAT) project is determined to scrutinize both these potential brain-body interactions in PF. The main objectives are: a) To determine the relationship between PF, activities in certain brain areas, activity in a certain part of the autonomic nervous system (the sympathetic branch), and immunological alterations; b) To determine whether PF is primarily dependent upon the brain's automatic predictions rather than the continuous sensory information mediated to the brain. To achieve these objectives, MAP-FAT will exploit an existing health registry on post-infective fatigue (preparatory part) and conduct a new post-infective cohort study (main part) in which a total of 150 individuals with "kissing disease" and 150 healthy controls are followed for six months. Investigations include: a) Clinical and demographic assessment; b) Questionnaire charting; c) Functional and structural imaging of the brain (multimodal brain MRI); d) Assessment of autonomic nervous system activity; e) Deep immunological profiling; and f) Behavioral experiments. The latter are specifically designed to disentangle the relative contributions of the brain's automatic predictions and sensory input for the experience of PF. In addition, one of the experiments includes concurrent functional brain imaging, autonomic nervous system assessment, and immunological profiling during experimental injections of drugs that impact on autonomic activity; this experiment is key for addressing the causal association between brain functions, autonomic activity and immunological disturbance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBV | – | –Individuals with acute Epstein-Barr virus infection |
| HC | – | –Healthy control individuals (ie., no acute EBV infection) |
Who may qualify
- Ages
- 16 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The population served by the South-Eastern Norway Regional Health Authority (approximately 3.1M)
Key inclusion criteria (2 listed)
- EBV infection, laboratory confirmed.
- First symptoms > 3 and < 6 weeks away
Key exclusion criteria (7 listed)
- Co-morbidity, including mental illness (seasonal allergy/asthma is accepted if no signs/symptoms)
- Usage of pharmaceuticals (hormonal contraception and paracetamol/ibuprofen is accepted)
- Concurrent demanding life event causing fatigue.
- Disability impacting on daily living.
- Regular smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ASP difference
Time frame: At six months' follow-up
The difference in symptom ratings between neutral and negative affect provoking pictures during the Affect and Symptom Paradigm (ASP)
3 secondary outcomes
VHBP regression ratio
Time frame: At six months' follow-up
INSULA connectivity
Time frame: At six months' follow-up
FATIGUE CFQ
Time frame: At six months' follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. Anonymized IPD from all elements of MAP-FAT will be shared at a trusted, public repository such as ZENODO. We will adhere to the FAIR (findable, accessible, interoperable, reusable) principles: * A unique and persistent Digital Object Identifier (DOI) will be assigned to each item in the public repository, thus making them easily findable. * MAP-FAT (meta)data will be retrievable by its identifier; all beneficiaries will ensure open access to the deposited data, following the principle 'as open as possible as closed as necessary'. * MAP-FAT (meta)data will use a formal, accessible, shared, and broadly applicable language for knowledge representation. Interoperability resources such as FAIRsharing will be applied. * The conditions under which the data can be used will be made transparent through easy-to-use copyright licenses, such as Creative Commons (Creative Commons Attribution International Public License, CC BY) or Creative Commons Public Domain Dedication (CC 0).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue Post Viral, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vegard Bruun Bratholm Wyller (+4791166681, v.b.b.wyller@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASP difference (time frame: At six months' follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.