Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère (RespiMuS)
Primary Purpose
Multiple Sclerosis, Respiration Disorders
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Polysomnography
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis criteria of multiple sclerosis (MS) fulfilling revised McDonald criteria (2010)
- EDSS score from 6.5
- no relapse during the 3 last months
- Informed consent prior to any study procedure
Exclusion Criteria:
- Any severe Chronic Obstructive Pulmonary Disease (III or IV)
- Pregnancy or woman with childbearing potential
- contraindication to MRI
Sites / Locations
- Département de Neurologie-Groupe Hospitalier Pitié-SalpêtrièreRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with severe MS
Arm Description
polysomnography and functional pulmonary testings.
Outcomes
Primary Outcome Measures
Polysomnography
presence of phasic activation of respiratory muscles
Secondary Outcome Measures
Respiratory function testing
difference between vital capacity upright and supine position (liter)
Respiratory function testing
maximal inspiratory pressure (mmHg)
Respiratory function testing
maximal expiratory pressure (mmHg)
Respiratory function testing
SNIP (mmHg)
Respiratory function testing
peak flow (liter)
Cerebral and cervical spine MRI
cerebral : 3DT1MPRAGE, T2 FLAIR, DWI / spine: 3DT1MPRAGE, axial T2 MEDIC, T2-WSPACE
Expanded Disability Status Scale (EDSS)
Neurological assessment of disability related to multiple sclerosis, total score from 0 to 10
BICAMS
Brief International Assessment for Multiple Sclerosis
Full Information
NCT ID
NCT03339817
First Posted
October 31, 2017
Last Updated
June 21, 2018
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT03339817
Brief Title
Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère
Acronym
RespiMuS
Official Title
Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
November 15, 2019 (Anticipated)
Study Completion Date
January 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Respiration Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with severe MS
Arm Type
Other
Arm Description
polysomnography and functional pulmonary testings.
Intervention Type
Diagnostic Test
Intervention Name(s)
Polysomnography
Other Intervention Name(s)
functional pulmonary testings
Intervention Description
During polysomnographia and functional pulmonary testing, signs of diaphragmatic dysfunction responsible for respiratory disorders will be searched.
Primary Outcome Measure Information:
Title
Polysomnography
Description
presence of phasic activation of respiratory muscles
Time Frame
Baseline only_during one night
Secondary Outcome Measure Information:
Title
Respiratory function testing
Description
difference between vital capacity upright and supine position (liter)
Time Frame
Baseline only
Title
Respiratory function testing
Description
maximal inspiratory pressure (mmHg)
Time Frame
Baseline only
Title
Respiratory function testing
Description
maximal expiratory pressure (mmHg)
Time Frame
Baseline only
Title
Respiratory function testing
Description
SNIP (mmHg)
Time Frame
Baseline only
Title
Respiratory function testing
Description
peak flow (liter)
Time Frame
Baseline only
Title
Cerebral and cervical spine MRI
Description
cerebral : 3DT1MPRAGE, T2 FLAIR, DWI / spine: 3DT1MPRAGE, axial T2 MEDIC, T2-WSPACE
Time Frame
Baseline only
Title
Expanded Disability Status Scale (EDSS)
Description
Neurological assessment of disability related to multiple sclerosis, total score from 0 to 10
Time Frame
Baseline only
Title
BICAMS
Description
Brief International Assessment for Multiple Sclerosis
Time Frame
Baseline only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis criteria of multiple sclerosis (MS) fulfilling revised McDonald criteria (2010)
EDSS score from 6.5
no relapse during the 3 last months
Informed consent prior to any study procedure
Exclusion Criteria:
Any severe Chronic Obstructive Pulmonary Disease (III or IV)
Pregnancy or woman with childbearing potential
contraindication to MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maillart Elisabeth, MD
Phone
01 42 16 19 75
Email
elisabeth.maillart@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maillart Elisabeth, MD
Organizational Affiliation
Hopital de la Pitié Salpétrière
Official's Role
Principal Investigator
Facility Information:
Facility Name
Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Maillart, PI
Phone
01 42 16 19 75
Email
elisabeth.maillart@aphp.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
33538688
Citation
Zeidan S, Redolfi S, Papeix C, Bodini B, Louapre C, Arnulf I, Maillart E. Unexpected REM sleep excess associated with a pontine lesion in multiple sclerosis. J Clin Sleep Med. 2021 May 1;17(5):1117-1119. doi: 10.5664/jcsm.9114.
Results Reference
derived
Learn more about this trial
Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère
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