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Sleep Medical Treatment in MS Patients Suffering From Fatigue

TerminatedNA

Sponsor: Charite University, Berlin, Germany

Conditions: Multiple Sclerosis, Fatigue

Interventions: Sleep medical treatment

Countries: Germany

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Berlin, Germany