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Completed

NCT Number: NCT03339817

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

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Diagnostic Test

During polysomnographia and functional pulmonary testing, signs of diaphragmatic dysfunction responsible for respiratory disorders will be searched.

Other names: functional pulmonary testings

Primary outcomes

  1. Polysomnography

    Time frame: Baseline only_during one night

    presence of phasic activation of respiratory muscles

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Acronym: RespiMuS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2017
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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