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Sleep-in-MS: Sleep Medical Treatment in MS Patients Suffering From Fatigue

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Terminated
CT.gov ID
NCT03759249
Collaborator
Genzyme, a Sanofi Company (Industry)
51
Enrollment
1
Location
2
Arms
65.7
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Sleep medical treatment
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
51 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 :
Dec 8, 2015
Actual Primary Completion Date :
May 31, 2021
Actual Study Completion Date :
May 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Modified Fatigue Impact Scale value [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charité University Medicine Berlin Berlin Germany 10117

Sponsors and Collaborators

  • Charite University, Berlin, Germany
  • Genzyme, a Sanofi Company

Investigators

  • Principal Investigator: Friedemann Paul, MD, Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Friedemann Paul, Prof. Dr. Friedemann Paul, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT03759249
Other Study ID Numbers:
  • SLEEPFAMS
First Posted:
Nov 29, 2018
Last Update Posted:
Aug 3, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Friedemann Paul, Prof. Dr. Friedemann Paul, Charite University, Berlin, Germany
multiple sclerosis
polysomnography
Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Fatigue

Study Results

No Results Posted as of Aug 3, 2021