Sleep problems, fatigue, and thinking ability in people with MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort enrolls adults with multiple sclerosis who have at least mild fatigue and compares them with control participants referred for sleep evaluation. Participants undergo overnight polysomnography, standardized questionnaires (including the FSMC), and objective motor and cognitive fatigability testing to link sleep architecture to subjective and objective fatigue and cognitive performance. The study will compare patients with and without sleep-related abnormalities and explore which sleep parameters most strongly correlate with fatigue severity and performance decline. Standard eligibility criteria (age 18–79, German language proficiency, adequate hearing/vision, and no interfering medications or other neurological disorders) are applied.

Why it matters

Who can join: the full rules

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)

Where it's running

• University Hospital Düsseldorf
  Düsseldorf, Germany Recruiting
• Maria Hilf Clinics
  Mönchengladbach, Germany Recruiting

Study contacts

• Study coordinator: Carolin Balloff, Dr. rer. nat.
• Email: carolin.balloff@gmail.com
• Phone: +4917622970340

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.