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

• Conditions: G35; Multiple sclerosis

• Registration Number: DRKS00025573
• Lead Sponsor: niversitätsklinik für Neurologie,Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-16
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

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)

Exclusion Criteria

- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 2: Established validity, internal consistency, reliability and responsiveness of the German version of the NSI-MS (NSI-MS-G) to assess sleep disorders and daytime sleepiness in MS patients.

Secondary Outcome Measures

Name	Time	Method
Phase 1: Availability of a German version of the NSI-MS (NSI-MS-G) with adequate face and content validity and cross-culturally adapted to MS patients who live in Austria