- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04178239
Chronic Fatigue in Sarcoidosis
Neuropsychobiological Fingerprints of Chronic Fatigue in Sarcoidosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
NRW
-
Aachen, NRW, Germany, 52074
- University Hospital RWTH Aachen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- histologically diagnosed sarcoidosis
- age ≥18 years
- provision of written informed consent
- sufficient German language skills to fully understand all questionnaires
Exclusion Criteria:
- 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
- extensive tattoos
- current pregnancy
- claustrophobia
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chronic Fatigue
MFI score >53 points
|
fMRI neuropsychological questionnaires pneumologic diagnostics: blood samples, whole body plethysmography, walking test
|
No Chronic Fatigue
MFI score < 54 points
|
fMRI neuropsychological questionnaires pneumologic diagnostics: blood samples, whole body plethysmography, walking test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
1 day of study participation
|
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.
|
1 day of study participation
|
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.
|
1 day of study participation
|
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. |
1 day of study participation
|
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.
|
1 day of study participation
|
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).
|
1 day of study participation
|
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.
|
1 day of study participation
|
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.
|
1 day of study participation
|
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.
|
1 day of study participation
|
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.
|
1 day of study participation
|
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.
|
1 day of study participation
|
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.
|
1 day of study participation.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Dreher, RWTH Aachen University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-082
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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