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

Charité University Medicine Berlin

Status

Terminated

Conditions

Multiple Sclerosis

Fatigue

Treatments

Other: Sleep medical treatment

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03759249

SLEEPFAMS

Details and patient eligibility

About

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).

Full 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.

Enrollment

51 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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