Sleep Medical Treatment in MS Patients Suffering From Fatigue

Study 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.

Official Title
-----------------
Control Fatigue: Sleep Medical Treatment as a Novel Therapeutic Approach to an Unmet Medical Need in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis, Fatigue

Intervention / Treatment
-----------------
* Other: Sleep medical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Standard Treatment of Sleep disorder according to applicable guideline | Other: Sleep medical treatment<br>* 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.<br>|
| No Intervention: Waiting list<br>Continuation of former treatment, after completing the study standard treatment of Sleep disorder according to applicable guidelines | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | six months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple sclerosis, polysomnography