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

December 3, 2025 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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • France
    • Paris
      • Paris, Paris, France, 75013
        • Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière

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

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.
Diagnostic test: Polysomnography
During polysomnographia and functional pulmonary testing, signs of diaphragmatic dysfunction responsible for respiratory disorders will be searched.
Other Names:
  • functional pulmonary testings

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.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

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.

General Publications

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 (Actual)

November 6, 2020

Study Completion (Actual)

November 6, 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 (Estimated)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

March 1, 2025

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

product manufactured in and exported from the U.S.

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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