Control Fatigue: Sleep Medical Treatment as a Novel Therapeutic Approach to an Unmet Medical Need in Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Modified Fatigue Impact Scale value
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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).
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.
Investigators
Friedemann Paul
Prof. Dr. Friedemann Paul
Charite University, Berlin, Germany
Eligibility Criteria
Inclusion Criteria
- •multiple sclerosis
- •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)
Outcomes
Primary Outcomes
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