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

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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

Tracking Information
First Submitted Date  ICMJE October 31, 2017
First Posted Date  ICMJE November 13, 2017
Last Update Posted Date June 25, 2018
Actual Study Start Date  ICMJE January 11, 2018
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
Polysomnography [ Time Frame: Baseline only_during one night ]
presence of phasic activation of respiratory muscles
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
Polysomnography [ Time Frame: Baseline only_during one night ]
study of paradoxal sleep (duration...) O2 and CO2 during sleep
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
  • Respiratory function testing [ Time Frame: Baseline only ]
    difference between vital capacity upright and supine position (liter)
  • Respiratory function testing [ Time Frame: Baseline only ]
    maximal inspiratory pressure (mmHg)
  • Respiratory function testing [ Time Frame: Baseline only ]
    maximal expiratory pressure (mmHg)
  • Respiratory function testing [ Time Frame: Baseline only ]
    SNIP (mmHg)
  • Respiratory function testing [ Time Frame: Baseline only ]
    peak flow (liter)
  • Cerebral and cervical spine MRI [ Time Frame: Baseline only ]
    cerebral : 3DT1MPRAGE, T2 FLAIR, DWI / spine: 3DT1MPRAGE, axial T2 MEDIC, T2-WSPACE
  • Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline only ]
    Neurological assessment of disability related to multiple sclerosis, total score from 0 to 10
  • BICAMS [ Time Frame: Baseline only ]
    Brief International Assessment for Multiple Sclerosis
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
  • Respiratory function testing [ Time Frame: Baseline only ]
    Vital capacity (L), maximal inspiratory pressure, maximal expiratory pressure
  • Cerebral and cervical spine MRI [ Time Frame: Baseline only ]
  • EDSS score (Expanded Disability Status Scale) [ Time Frame: Baseline only ]
    Neurological assessment of disability related to multiple sclerosis
  • BICAMS [ Time Frame: Baseline only ]
    Brief International Assessment for Multiple Sclerosis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère
Official Title  ICMJE Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère
Brief Summary The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Multiple Sclerosis
  • Respiration Disorders
Intervention  ICMJE 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
Study Arms  ICMJE Patients with severe MS
polysomnography and functional pulmonary testings.
Intervention: Diagnostic Test: Polysomnography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 7, 2017)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 10, 2020
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03339817
Other Study ID Numbers  ICMJE C16-111
2017-A01845-48 ( Registry Identifier: RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maillart Elisabeth, MD Hopital de la Pitié Salpétrière
PRS Account Institut National de la Santé Et de la Recherche Médicale, France
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP