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

NCT ID: NCT03339817

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-11

Study Completion Date

2020-11-06

Brief Summary

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

Detailed Description

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Conditions

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Multiple Sclerosis Respiration Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with severe MS

polysomnography and functional pulmonary testings.

Group Type OTHER

Polysomnography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Polysomnography

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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functional pulmonary testings

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maillart Elisabeth, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital de la Pitié Salpétrière

Locations

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Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière

Paris, Paris, France

Site Status

Countries

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France

References

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Zeidan S, Redolfi S, Papeix C, Bodini B, Louapre C, Arnulf I, Maillart E. Unexpected REM sleep excess associated with a pontine lesion in multiple sclerosis. J Clin Sleep Med. 2021 May 1;17(5):1117-1119. doi: 10.5664/jcsm.9114.

Reference Type RESULT
PMID: 33538688 (View on PubMed)

Other Identifiers

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2017-A01845-48

Identifier Type: REGISTRY

Identifier Source: secondary_id

C16-111

Identifier Type: -

Identifier Source: org_study_id

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