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

The Effects of Sleep Disturbances on Fatigue and Cognition in Multiple Sclerosis

We will try to see if sleep problems explain why adults with MS feel very tired and have trouble thinking.

Quick facts

• Study type: Observational
• Enrollment: 837 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: Heinrich-Heine University, Duesseldorf (other)
• Drugs / interventions: immunotherapy, Ocrelizumab
• Locations: 2 sites (Düsseldorf and 1 other locations)
• Trial ID: NCT07426991 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–79 with a diagnosis of MS (2017 McDonald criteria), at least mild fatigue (FSMC ≥ 43), adequate hearing/vision, German language proficiency, and capacity to consent are ideal candidates.

Not a fit: People outside the 18–79 age range, those with other neurological disorders (except migraine), or those taking medications that alter sleep recordings may not benefit from the study findings.

Why it matters

Potential benefit: If successful, the findings could identify treatable sleep disorders that, when addressed, reduce fatigue and improve thinking and quality of life for people with MS.

How similar studies have performed: Prior research has linked sleep disorders to fatigue and cognitive problems in MS, but few studies used full polysomnography and causal relationships remain unproven.

Eligibility criteria

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 this trial is running

Düsseldorf and 1 other locations

• University Hospital Düsseldorf — Düsseldorf, Germany (RECRUITING)
• Maria Hilf Clinics — Mönchengladbach, Germany (RECRUITING)

Study contacts

• Study coordinator: Carolin Balloff, Dr. rer. nat.

Conditions: Multiple Sclerosis, Remitting-Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Secondary Progress Multiple Sclerosis, Fatigue Syndrome, Chronic, Sleep Disorders, MS, Sleep