SarcoidosisNCT04178239
Chronic Fatigue in Sarcoidosis
An observational study of Sarcoidosis, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Background: Chronic fatigue (CF) is a prominent symptom in many sarcoidosis patients, affecting quality of life (QoL) and interfering with treatment. This study investigates neuropsychobiological mechanisms and markers of CF in sarcoidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- fMRI, questionnaires, pneumologic diagnostics
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- 10 Mar 2017to 2 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sarcoidosis patients (histologically diagnosed)
Who may be able to join
- histologically diagnosed sarcoidosis
- age ≥18 years
- provision of written informed consent
- sufficient German language skills to fully understand all questionnaires
Who cannot join
- patients unable to understand study-related information
- insufficient language skills in German language
- MRI-related contraindications:
- any kind of implants or extraneous material inside the body
- past thoracic or ophthalmologic surgery
- medical history of epilepsy, tinnitus or seizure
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- extensive tattoos
- current pregnancy
- claustrophobia
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Neuropsychobiological Fingerprints of Chronic Fatigue in Sarcoidosis
Background: Chronic fatigue (CF) is a prominent symptom in many sarcoidosis patients, affecting quality of life (QoL) and interfering with treatment. This study investigates neuropsychobiological mechanisms and markers of CF in sarcoidosis.
Read the detailed description
Patients with a histological diagnosis of sarcoidosis are included. The Multidimensional Fatigue Inventory (MFI) is used to define patients with and without CF. All patients are then characterized using several fatigue, depression, QoL and executive functioning questionnaires. Cognitive functioning and underlying neural correlates are assessed using an n-back task measuring working memory and (sustained) attention during functional magnetic resonance imaging (fMRI). Sarcoidosis disease activity is determined using lung function, laboratory parameters, and exercise capacity.
- Conditions
- Sarcoidosis
- Being tested
- fMRI, questionnaires, pneumologic diagnostics
- Keywords
- Fatigue, fMRI
- Medical subject headings
- Sarcoidosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI, questionnaires, pneumologic diagnosticsDiagnostic test
fMRI neuropsychological questionnaires pneumologic diagnostics: blood samples, whole body plethysmography, walking test
| Study group | Role | What they receive |
|---|---|---|
| Chronic Fatigue | MFI score >53 points Receives: Diagnostic Test: fMRI, questionnaires, pneumologic diagnostics | |
| No Chronic Fatigue | MFI score < 54 points Receives: Diagnostic Test: fMRI, questionnaires, pneumologic diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity
Measured by a Fatigue questionnaire that has frequently been used in cohorts of sarcoidosis patients, the Multidimensional Fatigue Inventory (MFI).
It consists of 20 items. For each item a score of 1 to 5 is possible, resulting in a total score of 20-100. Higher scores indicate a higher level of fatigue. In this study fatigue is diagnosed in patients with a total score of >53 based on the 75th percentile of norm values as primary developed by Kuhnt et al and used in several studies with cohorts of sarcoidosis patients.
Measured: 1 day of study participation
Fatigue
In addition to the MFI the Fatigue Assessement Scale (FAS) is performed. It is frequently used in cohorts of sarcoidosis patients. With its 10 Items the possible total score varies from 10 to 50, higher scores indicate more fatigue.
Measured: 1 day of study participation
Impact of fatigue on health-related quality of life
Assessed by the Fatigue Impact Scale (FIS). It includes 40 items resulting in a total score from 0 to 160. Higher values indicate more fatigue.
Measured: 1 day of study participation
Cognitive functioning and underlying neural correlates
Assessed by an n-back task measuring working memory and (sustained) attention during functional magnetic resonance imaging.
Reaction times and hit rates are measured.
Measured: 1 day of study participation
Sarcoidosis disease activity
Is assessed by s-IL2-receptor (U/ml), ACE-polymorphism (mU/L) and Neopterin (nmol/L) values from a blood sample. Higher values indicate a higher sarcoidosis disease activity.
Measured: 1 day of study participation
Lung function assessement
Whole body plethysmography is performed according to current recommendations. Parameters measured include total lung capacity (% predicted), vital capacity (% predicted), FEV1 (% predicted) and DLCO (% predicted).
Measured: 1 day of study participation
Exercise Capacity
Assessed by a standardised six-minute walking test. Walking distance the patient achieves within six minutes is assessed.
Measured: 1 day of study participation
Quality of life (self-assessment)
Assessed by the World Health Organization quality of Life Questionnaire, short form (WHO-QOL-BREF). The included Items assess aspects of quality of life in different domains: physical health domain, psychologic health domain, social relationships domain, environmental health domain, global domain. Domain scores are scaled in a positive direction, therefore higher scores denote higher quality of life. Scores from 0 to 100 are possible in each domain.
Measured: 1 day of study participation
Depression (self-assessment)
Patients are asked to perform the ADS (Allgemeine Depressionsskala). A total score from 0 to 60 points is possible, while higher scores indicate more signs and symptoms of depression.
Measured: 1 day of study participation
Depression (third-party-assessment)
Assessed by the Hamilton Depression Scale (HAMD). A total score of 0 to 62 points is possible with higher scores indicating more signs and symptoms of depression.
Measured: 1 day of study participation
Anxiety
Assessed by the State-Trait-Anxiety-Inventory (STAI). It consists of two subscales, each including 20 items. For each subscale there is a possible score from 20 to 80 points with higher scores indicating more anxiety.
Measured: 1 day of study participation
Executive functioning
Assessed by the Trail-Making-Test (TMT-A and -B). Time necessary for completion of the task is measured, shorter periods of time indicate a better executive functioning in terms of attention.
Measured: 1 day of study participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start10 Mar 2017
- Primary completion2 Feb 2018
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ.-Prof. Dr. med. Michael Dreher, RWTH Aachen University
- Investigators
- Michael Dreher, Principal investigator, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178239
- Sponsor's protocol ID
- 16-082
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kettenbach S, Radke S, Muller T, Habel U, Dreher M. Neuropsychobiological Fingerprints of Chronic Fatigue in Sarcoidosis. Front Behav Neurosci. 2021 Jul 26;15:633005. doi: 10.3389/fnbeh.2021.633005. eCollection 2021.
PubMed 34381339
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychobiological Fingerprints of Chronic Fatigue in Sarcoidosis
- ClinicalTrials.gov ID
- NCT04178239
- Acronym / sponsor ID
- 16-082
- Conditions
- Sarcoidosis
- Keywords
- Fatigue, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 26 Nov 2019 (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.
Background: Chronic fatigue (CF) is a prominent symptom in many sarcoidosis patients, affecting quality of life (QoL) and interfering with treatment. This study investigates neuropsychobiological mechanisms and markers of CF in sarcoidosis.
Detailed description
Patients with a histological diagnosis of sarcoidosis are included. The Multidimensional Fatigue Inventory (MFI) is used to define patients with and without CF. All patients are then characterized using several fatigue, depression, QoL and executive functioning questionnaires. Cognitive functioning and underlying neural correlates are assessed using an n-back task measuring working memory and (sustained) attention during functional magnetic resonance imaging (fMRI). Sarcoidosis disease activity is determined using lung function, laboratory parameters, and exercise capacity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Fatigue | – | Diagnostic Test: fMRI, questionnaires, pneumologic diagnosticsMFI score >53 points |
| No Chronic Fatigue | – | Diagnostic Test: fMRI, questionnaires, pneumologic diagnosticsMFI score < 54 points |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sarcoidosis patients (histologically diagnosed)
Key inclusion criteria (4 listed)
- histologically diagnosed sarcoidosis
- age ≥18 years
- provision of written informed consent
- sufficient German language skills to fully understand all questionnaires
Key exclusion criteria (9 listed)
- patients unable to understand study-related information
- insufficient language skills in German language
- MRI-related contraindications:
- any kind of implants or extraneous material inside the body
- past thoracic or ophthalmologic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI, questionnaires, pneumologic diagnosticsfMRI neuropsychological questionnaires pneumologic diagnostics: blood samples, whole body plethysmography, walking test | Diagnostic test | Chronic Fatigue, No Chronic Fatigue |
Primary outcome
Fatigue Severity
Time frame: 1 day of study participation
Measured by a Fatigue questionnaire that has frequently been used in cohorts of sarcoidosis patients, the Multidimensional Fatigue Inventory (MFI). It consists of 20 items. For each item a score of 1 to 5 is possible, resulting in a total score of 20-100. Higher scores indicate a higher level of fatigue. In this study fatigue is diagnosed in patients with a total score of >53 based on the 75th percentile of norm values as primary developed by Kuhnt et al and used in several studies with cohorts of sarcoidosis patients.
Fatigue
Time frame: 1 day of study participation
In addition to the MFI the Fatigue Assessement Scale (FAS) is performed. It is frequently used in cohorts of sarcoidosis patients. With its 10 Items the possible total score varies from 10 to 50, higher scores indicate more fatigue.
Impact of fatigue on health-related quality of life
Time frame: 1 day of study participation
Assessed by the Fatigue Impact Scale (FIS). It includes 40 items resulting in a total score from 0 to 160. Higher values indicate more fatigue.
Cognitive functioning and underlying neural correlates
Time frame: 1 day of study participation
Assessed by an n-back task measuring working memory and (sustained) attention during functional magnetic resonance imaging. Reaction times and hit rates are measured.
Sarcoidosis disease activity
Time frame: 1 day of study participation
Is assessed by s-IL2-receptor (U/ml), ACE-polymorphism (mU/L) and Neopterin (nmol/L) values from a blood sample. Higher values indicate a higher sarcoidosis disease activity.
Lung function assessement
Time frame: 1 day of study participation
Whole body plethysmography is performed according to current recommendations. Parameters measured include total lung capacity (% predicted), vital capacity (% predicted), FEV1 (% predicted) and DLCO (% predicted).
Exercise Capacity
Time frame: 1 day of study participation
Assessed by a standardised six-minute walking test. Walking distance the patient achieves within six minutes is assessed.
Quality of life (self-assessment)
Time frame: 1 day of study participation
Assessed by the World Health Organization quality of Life Questionnaire, short form (WHO-QOL-BREF). The included Items assess aspects of quality of life in different domains: physical health domain, psychologic health domain, social relationships domain, environmental health domain, global domain. Domain scores are scaled in a positive direction, therefore higher scores denote higher quality of life. Scores from 0 to 100 are possible in each domain.
Depression (self-assessment)
Time frame: 1 day of study participation
Patients are asked to perform the ADS (Allgemeine Depressionsskala). A total score from 0 to 60 points is possible, while higher scores indicate more signs and symptoms of depression.
Depression (third-party-assessment)
Time frame: 1 day of study participation
Assessed by the Hamilton Depression Scale (HAMD). A total score of 0 to 62 points is possible with higher scores indicating more signs and symptoms of depression.
Anxiety
Time frame: 1 day of study participation
Assessed by the State-Trait-Anxiety-Inventory (STAI). It consists of two subscales, each including 20 items. For each subscale there is a possible score from 20 to 80 points with higher scores indicating more anxiety.
Executive functioning
Time frame: 1 day of study participation.
Assessed by the Trail-Making-Test (TMT-A and -B). Time necessary for completion of the task is measured, shorter periods of time indicate a better executive functioning in terms of attention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Derived from this study: PubMed 34381339Kettenbach S, Radke S, Muller T, Habel U, Dreher M. Neuropsychobiological Fingerprints of Chronic Fatigue in Sarcoidosis. Front Behav Neurosci. 2021 Jul 26;15:633005. doi: 10.3389/fnbeh.2021.633005. eCollection 2021.
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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. This study is not recruiting at the moment.
Michael Dreher principal investigator
RWTH Aachen University Hospital
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 Sarcoidosis, run by RWTH Aachen University at 1 site in Germany.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 27 Nov 2019. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity (time frame: 1 day of study participation). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178239, which also lists 1 linked publication.
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 27 Nov 2019.