Status:
TERMINATED
Sleep Medical Treatment in MS Patients Suffering From Fatigue
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Multiple Sclerosis
Fatigue
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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 the...
Eligibility Criteria
Inclusion
- multiple sclerosis
- fatigue
- MFIS values greater than 34 or Pittsburgh Sleep Quality Index greater than 5
Exclusion
- 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
Key Trial Info
Start Date :
December 8 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03759249
Start Date
December 8 2015
End Date
May 31 2021
Last Update
August 3 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charité University Medicine Berlin
Berlin, Germany, 10117