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Sleep Medical Treatment in MS Patients Suffering From Fatigue (Sleep-in-MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03759249
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : September 2, 2019
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Friedemann Paul, Charite University, Berlin, Germany

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Fatigue Other: Sleep medical treatment Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Modified Fatigue Impact Scale value [ Time Frame: six months after treatment ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • multiple sclerosis
  • fatigue
  • MFIS values greater than 34 or Pittsburgh Sleep Quality Index greater than 5

Exclusion Criteria:

  • Expanded disability status scale greater than 5
  • relapse in the last four weeks
  • immunosuppressants in the last two years
  • therapy with positive airway pressure (CPAP or BIPAP/ASV)
  • treatment with opioids
  • treatment with oestrogen
  • body mass index greater than 40
  • depression (beck depression inventory (BDI) values greater 20; in case of treatment with antidepressants BDI values greater than 12 or suicidal ideas)
  • pregnancy
  • anaemia (hemoglobine < 11,5 g/dl in women and < 12,5 g/dl in men)
  • thyroid-stimulating hormone outside the normal range
  • renal insufficiency (creatinine clearance < 75ml/min)
  • elevated transaminases (tripled)
  • chronic heart failure (NYHA II, III or IV)
  • respiratory insufficiency (CO2 > 45 mmHg or pO2 < 60 mmHg (capillary or arterial) or long-term oxygen therapy)
  • carcinoma in the medical history (except for curative approach without relapse in the last 10 years)
  • chemotherapy
  • poorly controlled diabetes (Glycated hemoglobin greater than 8 per cent)
  • pituitary adenomas
  • diabetes insipidus
  • fibromyalgia
  • unclear weight loss greater than 12 kg in one year
  • myasthenia gravis or any neuromuscular disorder
  • ulcerating colitis or Crohn's disease
  • AIDS or infection with HIV
  • acute infection in the last two months
  • stroke or apoplexy in the history
  • Parkinson's Disease
  • substance or drug abuse
  • participation in other interventional trials
  • capacity for consent is lacking

Information from the National Library of Medicine

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 identifier (NCT number): NCT03759249

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Contact: Christian Veauthier, MD +49 30 450 ext 513 120
Contact: Judith Bellmann-Strobl, MD

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Charité University Medicine Berlin Recruiting
Berlin, Germany, 10117
Contact: Christian Veauthier, MD    +49 30 450 ext 513 120   
Contact: Judith Bellmann-Strobl, MD   
Sponsors and Collaborators
Charite University, Berlin, Germany
Genzyme, a Sanofi Company
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Principal Investigator: Friedemann Paul, MD Charite University, Berlin, Germany

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Responsible Party: Friedemann Paul, Prof. Dr. Friedemann Paul, Charite University, Berlin, Germany Identifier: NCT03759249     History of Changes
Other Study ID Numbers: SLEEPFAMS
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Friedemann Paul, Charite University, Berlin, Germany:
multiple sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms