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Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis

Recruitingn/aAges 18 Years - 79 YearsAllHeinrich-Heine University, Duesseldorf
NCT07426991 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Fatigue is a prevalent symptom in patients with multiple sclerosis (MS) and is associated with considerable impairment in quality of life as well as loss of occupational capacity. Sleep disturbances are regarded as a critical factor in the development of fatigue and are frequently observed in individuals with MS. However, they often remain underrecognized, undiagnosed, and consequently untreated. Polysomnography, the gold standard for assessing sleep architecture and quality, has rarely been applied in the investigation of sleep disorders in MS. Accordingly, uncertainties remain regarding the prevalence and extent to which sleep disturbances contribute to fatigue in this population. Moreover, emerging evidence suggests an association between sleep disorders and cognitive dysfunction in MS. Yet, it is unclear whether cognitive impairment arises from the sleep disorder itself, from the re

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 and ≤ 79 years (all groups) * Adequate (corrected) hearing and vision to complete neuropsychological testing (all groups) * Sufficient proficiency in German to participate in assessments (all groups) * Capacity to provide informed consent and understanding of study procedures (all groups) * Diagnosis of MS according to the 2017 revised McDonald criteria (MS group) * Indication for sleep medicine evaluation due to at least mild fatigue, operationalized as ≥ 43 points on the Fatigue Scale for Motor and Cognitive Functions (FSMC) (MS group) * Indication for sleep medicine evaluation (control group) Exclusion Criteria: * Lack of signed informed consent or inability to provide consent (all groups) * Age \< 18 years or \> 79 years (all groups) * Presence of another neurological disorder in addition to MS, with the exception of migraine (all groups) * Use of medications that influence polysomnographic parameters (e.g., benzodiazepines) (all groups) * Uncorrected hearing or vision impairment and/or insufficient German language proficiency likely to impact neuropsychological test results (all groups)
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What it tests

  • No Intervention: Observational Cohort
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Where

2 sites
University Hospital Düsseldorf
Düsseldorf, Germany
Maria Hilf Clinics
Mönchengladbach, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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