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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025573

Enrollment

430

Registered

2021-06-16

Start date

2021-06-21

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G35

Interventions

Group 1: Two-phase questionnaire validation study to validate the German translation of the Neurological Sleep Index- Multiple Sclerosis Phase 1 (Reha Zentrum Münster, Österreich): Interviews of MS pa

demographic and disease specific data will be taken from the medical records of patients. Interviews will be audio-recorded (administration time 55-80 minutes). Following a qualitative data analysis,

Survey using following questionnaires: prefinal NSI-MS-G, German versions of the Neurological Fatigue Index- Multiple Sclerosis (NFI-MS), Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Austria

Contacts

Public ContactBarbara Seebacher

Reha Zentrum MünsterAbteilung für Rehabilitationsforschung

barbara.seebacher@reha-muenster.at+43 5337 20004 6205

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026