Clinical trial NCT04178239: Chronic Fatigue in Sarcoidosis
Official title: Neuropsychobiological Fingerprints of Chronic Fatigue in Sarcoidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Keywords: Fatigue
fMRI
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sarcoidosis patients (histologically diagnosed)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue Severity
timeFrame: 1 day of study participation
measure: Fatigue
timeFrame: 1 day of study participation
measure: Impact of fatigue on health-related quality of life
timeFrame: 1 day of study participation
measure: Cognitive functioning and underlying neural correlates
timeFrame: 1 day of study participation
measure: Sarcoidosis disease activity
timeFrame: 1 day of study participation
measure: Lung function assessement
timeFrame: 1 day of study participation
measure: Exercise Capacity
timeFrame: 1 day of study participation
measure: Quality of life (self-assessment)
timeFrame: 1 day of study participation
measure: Depression (self-assessment)
timeFrame: 1 day of study participation
measure: Depression (third-party-assessment)
timeFrame: 1 day of study participation
measure: Anxiety
timeFrame: 1 day of study participation
measure: Executive functioning
timeFrame: 1 day of study participation.
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
state: NRW
Study officials:
affiliation: RWTH Aachen University Hospital
name: Michael Dreher
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.