German translation, cultural adaptation for Austria and validation of the Neurological Sleep Index - Multiple Sclerosis (NSI-MS) - NSI-MS GER

niversitätsklinik für Neurologie,Medizinische Universität Wien0 个研究点目标入组 430 人开始时间: 2021年6月16日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Males and females diagnosed with MS according to the (revised) McDonald criteria valid at the time of the diagnosis (Polman et al., 2011; Thompson et al., 2018)
•- Age =18 years
•- all MS disease courses (relapsing-remitting, primary and secondary progressive)
•- any ethnicity
•- fluent in German language
•- Expanded Disability Status Scale (EDSS) Score (Kurtzke, 1983) of 0 (no disability) to 9.0 (severe disability)

•- Comorbidity, which prevents a participation in the study according to the study investigators (e.g., malignant disease, other neurological or psychiatric disorders, severe depression or bipolar disorder)
•- any physical or congitive impairment, which prevents from a participation in the study according to the study investigators (e.g., dementia, massive cardiovascular impairment) jegliche Beeinträchtigung der körperlichen und geistigen Verfassung, die nach dem Ermessen der Prüfärzte keine aussagekräftige Teilnahme an der Studie ermöglicht (z.B.: Demenz, kardiovaskuläre Beeinträchtigungen etc.)
•- Any change in or adaptation of the symptomatic therapy (medication), which is known to impact fatigue/sleep behaviour in study participants
•- MS relapse 2 months prior to the study
•- MS relapse within the study period

发起方

niversitätsklinik für Neurologie,Medizinische Universität Wien