Actively Recruiting
The Effects of Sleep Disturbances on Fatigue and Cognition in Multiple Sclerosis
Led by Heinrich-Heine University, Duesseldorf · Updated on 2026-03-06
837
Participants Needed
2
Research Sites
47 weeks
Total Duration
On this page
Sponsors
H
Heinrich-Heine University, Duesseldorf
Lead Sponsor
M
Maria Hilf Clinics GmbH, Mönchengladbach
Collaborating Sponsor
AI-Summary
What this Trial Is About
Fatigue is a common and impactful symptom in people with multiple sclerosis (MS), often linked to sleep disturbances that are frequently overlooked and untreated. This research investigates how sleep disorders affect fatigue and cognitive performance in MS patients, including comparisons across different MS subtypes and the influence of various immunotherapies. The study also explores the use of artificial intelligence (AI) to enhance the analysis of sleep data. The study is a non-invasive, observational trial involving MS patients with fatigue and a control group of individuals with sleep complaints but no MS. Participants will undergo comprehensive assessments including overnight polysomnography to measure sleep quality, neuropsychological tests, and various questionnaires on fatigue, sleepiness, and mental health. A sub-study will compare patients on different MS therapies. Retrospective sleep data will be used to train AI models for automated sleep analysis. Participants will be involved in baseline evaluations including clinical exams, cognitive testing, and two nights of polysomnography, followed by a telephone assessment about 11 months later. Those with persistent fatigue will return for a repeat of the assessments approximately 12 months after baseline. Researchers will measure fatigue severity, cognitive function, sleep disorders, and other health parameters over time to better understand the relationships among sleep disturbances, fatigue, and cognition in MS.
CONDITIONS
Brief Title
Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 79 years
- Adequate (corrected) hearing and vision to complete neuropsychological testing
- Sufficient proficiency in German to participate in assessments
- Capacity to provide informed consent and understand study procedures
- Diagnosis of multiple sclerosis according to the 2017 revised McDonald criteria (for MS group)
- Indication for sleep medicine evaluation due to at least mild fatigue with a score of 43 or higher on the Fatigue Scale for Motor and Cognitive Functions (FSMC) (for MS group)
- Indication for sleep medicine evaluation (for control group)
You will not qualify if you...
- Lack of signed informed consent or inability to provide consent
- Age below 18 years or above 79 years
- Presence of another neurological disorder besides MS, except migraine
- Use of medications that affect sleep study parameters, such as benzodiazepines
- Uncorrected hearing or vision impairment or insufficient German proficiency likely to affect cognitive test results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline assessment period
Participants undergo detailed assessments including neuropsychological testing, questionnaires, and two nights of polysomnography to evaluate sleep disorders and fatigue.
1 baseline visit (in-person) with two nights of polysomnography
Duration - 12 to 18 months after baseline
Participants are contacted by telephone approximately 11 months after baseline to assess fatigue. Those with persistent fatigue are invited for a follow-up visit repeating the baseline assessments to monitor changes over 12 to 18 months.
1 telephone contact and up to 1 follow-up visit (in-person) depending on fatigue status
Trial Site Locations
Total: 2 locations
1
University Hospital Düsseldorf
Düsseldorf, Germany, 40223
Actively Recruiting
2
Maria Hilf Clinics
Mönchengladbach, Germany, 41063
Actively Recruiting
Research Team
C
Carolin Balloff, Dr. rer. nat.
P
Philipp Albrecht, Prof. Dr. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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