An interventional study of Sleep medical treatment in Multiple Sclerosis and Fatigue, sponsored by Charite University, Berlin, Germany. Terminated at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-03.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment
This study evaluates the effect of an extensive sleep medical investigation and of the subsequent treatment on multiple sclerosis (MS) related fatigue (provided a previously unknown sleep disorder was found).
Fatigue is among the most frequent symptoms in multiple sclerosis (MS) patients with substantial negative impact on quality of life and employment status; one third of patients describe fatigue as their most burdensome symptom. The enormous personal and socioeconomic burden of this symptom is in striking contrast to the limited therapeutic options.
In a previous polysomnographic study, we found a strong association between sleep disorders and fatigue in MS, measured with the Modified Fatigue Impact Scale (MFIS) and the Fatigue-Severity-Scale (FSS). Thus, it is conceivable that a consequent treatment of sleep disorders may improve fatigue, at least in a subset of patients which would yield a great benefit as pharmacological treatment options for fatigue are insufficient.
All consecutive MS patients of our outpatient clinic will be screened for fatigue. In case of fatigue (MFIS values > 34) or signs of sleep disorders (Pittsburgh sleep quality index > 5) the MS patients were invited to participate in the study. All MS patients will be interviewed by a sleep specialist, and will fill out questionnaires. Afterwards, they will be investigated by two consecutive polysomnographies in the sleep laboratory, followed (if necessary) by multiple sleep latencies tests. Subsequently, a sleep medical diagnosis will be established (no sleep disorder or sleep apnea or insomnia or restless legs syndrome or any other sleep disorders according to the International Classification of Sleep disorders 3th ed.). The primary endpoint will be the Modified Fatigue Impact Scale (MFIS) value six months after sleep medical treatment.
3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.
This study's enrollment of 51 is close to the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.
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Exclusion Criteria:
Standard Treatment of Sleep disorder according to applicable guideline
Other: Sleep medical treatment
Continuation of former treatment, after completing the study standard treatment of Sleep disorder according to applicable guidelines
The participant ungo Standard Sleep medical diagnostics. If a sleep disorder is diagnosed in the interventional Group the applicable therapy is conducted. If the participant is randomized in the waiting Group the applicable Therapy is initiated after study completion.
Modified Fatigue Impact Scale value
Measuring fatigue Total value of the Modified Fatigue Impact Scale: 0-84 (min-max), higher values represent increased fatigue, and lower values are considered to be a better outcome
Time frame: six months after treatment
Plan to share: No
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany →