Sleep Medical Treatment in MS Patients Suffering From Fatigue
Control Fatigue: Sleep Medical Treatment as a Novel Therapeutic Approach to an Unmet Medical Need in Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Recruitment number could not be reached, difficult conditions under Corona
This trial finished 5 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Sleep medical treatment
What it measured
Main measures
Modified Fatigue Impact Scale value
six months after treatment
Fatigue
Who could take part
MS (type not specified) · 18 to 75
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Background
Veauthier C, Hasselmann H, Gold SM, Paul F. The Berlin Treatment Algorithm: recommendations for tailored innovative therapeutic strategies for multiple sclerosis-related fatigue. EPMA J. 2016 Nov 24;7(1):25. doi: 10.1186/s13167-016-0073-3. eCollection 2016.Background
Veauthier C, Paul F. Fatigue in multiple sclerosis: which patient should be referred to a sleep specialist? Mult Scler. 2012 Feb;18(2):248-9. doi: 10.1177/1352458511411229. Epub 2011 Jun 7. No abstract available.Background
Veauthier C, Gaede G, Radbruch H, Gottschalk S, Wernecke KD, Paul F. Treatment of sleep disorders may improve fatigue in multiple sclerosis. Clin Neurol Neurosurg. 2013 Sep;115(9):1826-30. doi: 10.1016/j.clineuro.2013.05.018. Epub 2013 Jun 12.Background
Veauthier C, Radbruch H, Gaede G, Pfueller CF, Dorr J, Bellmann-Strobl J, Wernecke KD, Zipp F, Paul F, Sieb JP. Fatigue in multiple sclerosis is closely related to sleep disorders: a polysomnographic cross-sectional study. Mult Scler. 2011 May;17(5):613-22. doi: 10.1177/1352458510393772. Epub 2011 Jan 28.Background
Kaminska M, Kimoff RJ, Benedetti A, Robinson A, Bar-Or A, Lapierre Y, Schwartzman K, Trojan DA. Obstructive sleep apnea is associated with fatigue in multiple sclerosis. Mult Scler. 2012 Aug;18(8):1159-69. doi: 10.1177/1352458511432328. Epub 2011 Dec 19.Background
Cote I, Trojan DA, Kaminska M, Cardoso M, Benedetti A, Weiss D, Robinson A, Bar-Or A, Lapierre Y, Kimoff RJ. Impact of sleep disorder treatment on fatigue in multiple sclerosis. Mult Scler. 2013 Apr;19(4):480-9. doi: 10.1177/1352458512455958. Epub 2012 Aug 22.
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History
Started
Dec 2015
Main results due
May 2021
Finished
May 2021