Chronic Fatigue in Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

Neuropsychobiological Fingerprints of Chronic Fatigue in Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178239
• Other study ID #: 16-082
• Status: Completed
• Start date: March 10, 2017
• Est. completion date: February 2, 2018

Study information

• Verified date: November 2019
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Sarcoidosis

Intervention

Diagnostic Test:
• fMRI, questionnaires, pneumologic diagnostics
fMRI neuropsychological questionnaires pneumologic diagnostics: blood samples, whole body plethysmography, walking test

Locations

Country	Name	City	State
Germany	University Hospital RWTH Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day of study participation
Primary	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.	1 day of study participation
Primary	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.	1 day of study participation
Primary	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.	1 day of study participation
Primary	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.	1 day of study participation
Primary	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).	1 day of study participation
Primary	Exercise Capacity	Assessed by a standardised six-minute walking test. Walking distance the patient achieves within six minutes is assessed.	1 day of study participation
Primary	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.	1 day of study participation
Primary	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.	1 day of study participation
Primary	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.	1 day of study participation
Primary	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.	1 day of study participation
Primary	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.	1 day of study participation.