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临床试验/NCT04178239
NCT04178239已完成不适用

Neuropsychobiological Fingerprints of Chronic Fatigue in Sarcoidosis

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2017年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Exercise Capacity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Exercise Capacity

时间窗: 1 day of study participation

Assessed by a standardised six-minute walking test. Walking distance the patient achieves within six minutes is assessed.

Depression (third-party-assessment)

时间窗: 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.

Fatigue

时间窗: 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.

Impact of fatigue on health-related quality of life

时间窗: 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.

Fatigue Severity

时间窗: 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.

Cognitive functioning and underlying neural correlates

时间窗: 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.

Sarcoidosis disease activity

时间窗: 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.

Lung function assessement

时间窗: 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).

Anxiety

时间窗: 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.

Executive functioning

时间窗: 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.

Quality of life (self-assessment)

时间窗: 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.

Depression (self-assessment)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Univ.-Prof. Dr. med. Michael Dreher

Univ.-Prof. Dr. med. Michael Dreher

RWTH Aachen University

研究点 (1)

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