NCT03339817

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 11, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2020

Completed
Last Updated

December 10, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

October 31, 2017

Last Update Submit

December 3, 2025

Conditions

Respiration DisordersMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Polysomnography

    presence of phasic activation of respiratory muscles

    Baseline only_during one night

Secondary Outcomes (8)

  • Respiratory function testing

    Baseline only

  • Respiratory function testing

    Baseline only

  • Respiratory function testing

    Baseline only

  • Respiratory function testing

    Baseline only

  • Respiratory function testing

    Baseline only

  • +3 more secondary outcomes

Study Arms (1)

Patients with severe MS

OTHER

polysomnography and functional pulmonary testings.

Diagnostic Test: Polysomnography

Interventions

PolysomnographyDIAGNOSTIC_TEST

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

Also known as: functional pulmonary testings
Patients with severe MS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any severe Chronic Obstructive Pulmonary Disease (III or IV)
  • Pregnancy or woman with childbearing potential
  • contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière

Paris, Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 33538688RESULT

MeSH Terms

Conditions

Multiple SclerosisRespiration Disorders

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Maillart Elisabeth, MD

    Hopital de la Pitié Salpétrière

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 13, 2017

Study Start

January 11, 2018

Primary Completion

November 6, 2020

Study Completion

November 6, 2020

Last Updated

December 10, 2025

Record last verified: 2025-03

Locations

FR(1)