Chronic Fatigue in Sarcoidosis

NCT ID: NCT04178239

Last Updated: 2019-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-10

Study Completion Date

2018-02-02

Brief Summary

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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

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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

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Sarcoidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic Fatigue

MFI score \>53 points

fMRI, questionnaires, pneumologic diagnostics

Intervention Type DIAGNOSTIC_TEST

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

No Chronic Fatigue

MFI score \< 54 points

fMRI, questionnaires, pneumologic diagnostics

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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fMRI, questionnaires, pneumologic diagnostics

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Univ.-Prof. Dr. med. Michael Dreher

Univ.-Prof. Dr. med. Michael Dreher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Dreher

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University Hospital

Locations

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University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 34381339 (View on PubMed)

Other Identifiers

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16-082

Identifier Type: -

Identifier Source: org_study_id

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