- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03339817
Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère (RespiMuS)
June 21, 2018 updated by: Institut National de la Santé Et de la Recherche Médicale, France
The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maillart Elisabeth, MD
- Phone Number: 01 42 16 19 75
- Email: elisabeth.maillart@aphp.fr
Study Locations
-
-
-
Paris, France, 75013
- Recruiting
- Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière
-
Contact:
- Elisabeth Maillart, PI
- Phone Number: 01 42 16 19 75
- Email: elisabeth.maillart@aphp.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patients with severe MS
polysomnography and functional pulmonary testings.
|
During polysomnographia and functional pulmonary testing, signs of diaphragmatic dysfunction responsible for respiratory disorders will be searched.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Polysomnography
Time Frame: Baseline only_during one night
|
presence of phasic activation of respiratory muscles
|
Baseline only_during one night
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory function testing
Time Frame: Baseline only
|
difference between vital capacity upright and supine position (liter)
|
Baseline only
|
Respiratory function testing
Time Frame: Baseline only
|
maximal inspiratory pressure (mmHg)
|
Baseline only
|
Respiratory function testing
Time Frame: Baseline only
|
maximal expiratory pressure (mmHg)
|
Baseline only
|
Respiratory function testing
Time Frame: Baseline only
|
SNIP (mmHg)
|
Baseline only
|
Respiratory function testing
Time Frame: Baseline only
|
peak flow (liter)
|
Baseline only
|
Cerebral and cervical spine MRI
Time Frame: Baseline only
|
cerebral : 3DT1MPRAGE, T2 FLAIR, DWI / spine: 3DT1MPRAGE, axial T2 MEDIC, T2-WSPACE
|
Baseline only
|
Expanded Disability Status Scale (EDSS)
Time Frame: Baseline only
|
Neurological assessment of disability related to multiple sclerosis, total score from 0 to 10
|
Baseline only
|
BICAMS
Time Frame: Baseline only
|
Brief International Assessment for Multiple Sclerosis
|
Baseline only
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maillart Elisabeth, MD, Hopital de la Pitie Salpetriere
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 11, 2018
Primary Completion (Anticipated)
November 15, 2019
Study Completion (Anticipated)
January 10, 2020
Study Registration Dates
First Submitted
October 31, 2017
First Submitted That Met QC Criteria
November 7, 2017
First Posted (Actual)
November 13, 2017
Study Record Updates
Last Update Posted (Actual)
June 25, 2018
Last Update Submitted That Met QC Criteria
June 21, 2018
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C16-111
- 2017-A01845-48 (Registry Identifier: RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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