Sleep Medical Treatment in MS Patients Suffering From Fatigue (Sleep-in-MS)
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|ClinicalTrials.gov Identifier: NCT03759249|
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : September 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Fatigue||Other: Sleep medical treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Control Fatigue: Sleep Medical Treatment as a Novel Therapeutic Approach to an Unmet Medical Need in Multiple Sclerosis|
|Actual Study Start Date :||December 8, 2015|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Treatment group
Standard Treatment of Sleep disorder according to applicable guideline
Other: Sleep medical treatment
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.
No Intervention: Waiting list
Continuation of former treatment, after completing the study standard treatment of Sleep disorder according to applicable guidelines
- Modified Fatigue Impact Scale value [ Time Frame: six months after treatment ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759249
|Contact: Christian Veauthier, MD||+49 30 450 ext 513 email@example.com|
|Contact: Judith Bellmann-Strobl, MDfirstname.lastname@example.org|
|Charité University Medicine Berlin||Recruiting|
|Berlin, Germany, 10117|
|Contact: Christian Veauthier, MD +49 30 450 ext 513 120 email@example.com|
|Contact: Judith Bellmann-Strobl, MD firstname.lastname@example.org|
|Principal Investigator:||Friedemann Paul, MD||Charite University, Berlin, Germany|