Study Stopped
Recruitment number could not be reached, difficult conditions under Corona
Sleep Medical Treatment in MS Patients Suffering From Fatigue
Sleep-in-MS
Control Fatigue: Sleep Medical Treatment as a Novel Therapeutic Approach to an Unmet Medical Need in Multiple Sclerosis
1 other identifier
interventional
51
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started Dec 2015
Longer than P75 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 8, 2015
CompletedFirst Submitted
Initial submission to the registry
November 28, 2018
CompletedFirst Posted
Study publicly available on registry
November 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedAugust 3, 2021
July 1, 2021
5.5 years
November 28, 2018
July 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Treatment group
EXPERIMENTALStandard Treatment of Sleep disorder according to applicable guideline
Waiting list
NO INTERVENTIONContinuation of former treatment, after completing the study standard treatment of Sleep disorder according to applicable guidelines
Interventions
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.
Eligibility Criteria
You may qualify if:
- multiple sclerosis
- fatigue
- MFIS values greater than 34 or Pittsburgh Sleep Quality Index greater than 5
You may not qualify if:
- 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)
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Charite University, Berlin, Germanylead
- Genzyme, a Sanofi Companycollaborator
Study Sites (1)
Charité University Medicine Berlin
Berlin, 10117, Germany
Related Publications (6)
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.
PMID: 27904656BACKGROUNDVeauthier 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.
PMID: 21652611BACKGROUNDVeauthier 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.
PMID: 23764040BACKGROUNDVeauthier 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.
PMID: 21278050BACKGROUNDKaminska 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.
PMID: 22183937BACKGROUNDCote 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.
PMID: 22914848BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Friedemann Paul, MD
Charite University, Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Friedemann Paul
Study Record Dates
First Submitted
November 28, 2018
First Posted
November 29, 2018
Study Start
December 8, 2015
Primary Completion
May 31, 2021
Study Completion
May 31, 2021
Last Updated
August 3, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share