NCT04178239

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

November 18, 2019

Last Update Submit

November 25, 2019

Conditions

Sarcoidosis

Keywords

FatiguefMRI

Outcome Measures

Primary Outcomes (12)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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.

Study Arms (2)

Chronic Fatigue

MFI score \>53 points

Diagnostic Test: fMRI, questionnaires, pneumologic diagnostics

No Chronic Fatigue

MFI score \< 54 points

Diagnostic Test: fMRI, questionnaires, pneumologic diagnostics

Interventions

fMRI, questionnaires, pneumologic diagnosticsDIAGNOSTIC_TEST

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

Chronic FatigueNo Chronic Fatigue

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Sarcoidosis patients (histologically diagnosed)

You may qualify if:

  • histologically diagnosed sarcoidosis
  • age ≥18 years
  • provision of written informed consent
  • sufficient German language skills to fully understand all questionnaires

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (1)

  • 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.

    PMID: 34381339DERIVED

MeSH Terms

Conditions

SarcoidosisFatigue

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Michael Dreher

    RWTH Aachen University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr. med. Michael Dreher

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 26, 2019

Study Start

March 10, 2017

Primary Completion

February 2, 2018

Study Completion

February 2, 2018

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

DE(1)