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Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère (RespiMuS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339817
Recruitment Status : Unknown
Verified October 2017 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : November 13, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:
The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Respiration Disorders Diagnostic Test: Polysomnography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : January 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patients with severe MS
polysomnography and functional pulmonary testings.
Diagnostic Test: Polysomnography
During polysomnographia and functional pulmonary testing, signs of diaphragmatic dysfunction responsible for respiratory disorders will be searched.
Other Name: functional pulmonary testings




Primary Outcome Measures :
  1. Polysomnography [ Time Frame: Baseline only_during one night ]
    presence of phasic activation of respiratory muscles


Secondary Outcome Measures :
  1. Respiratory function testing [ Time Frame: Baseline only ]
    difference between vital capacity upright and supine position (liter)

  2. Respiratory function testing [ Time Frame: Baseline only ]
    maximal inspiratory pressure (mmHg)

  3. Respiratory function testing [ Time Frame: Baseline only ]
    maximal expiratory pressure (mmHg)

  4. Respiratory function testing [ Time Frame: Baseline only ]
    SNIP (mmHg)

  5. Respiratory function testing [ Time Frame: Baseline only ]
    peak flow (liter)

  6. Cerebral and cervical spine MRI [ Time Frame: Baseline only ]
    cerebral : 3DT1MPRAGE, T2 FLAIR, DWI / spine: 3DT1MPRAGE, axial T2 MEDIC, T2-WSPACE

  7. Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline only ]
    Neurological assessment of disability related to multiple sclerosis, total score from 0 to 10

  8. BICAMS [ Time Frame: Baseline only ]
    Brief International Assessment for Multiple Sclerosis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339817


Contacts
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Contact: Maillart Elisabeth, MD 01 42 16 19 75 elisabeth.maillart@aphp.fr

Locations
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France
Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Elisabeth Maillart, PI    01 42 16 19 75    elisabeth.maillart@aphp.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Maillart Elisabeth, MD Hopital de la Pitié Salpétrière
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03339817    
Other Study ID Numbers: C16-111
2017-A01845-48 ( Registry Identifier: RCB )
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiration Disorders
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Respiratory Tract Diseases