ClinicalTrials.gg
CompletedNCT03339817RespiMuSUpdated Dec 10, 2025

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

An interventional study of Polysomnography in Multiple Sclerosis and Respiration Disorders, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 376 studies in Multiple Sclerosis with a site in France — 64 open to participants now, 93 under way, 18 of them phase 3. Multiple Sclerosis · France.

Enrollment
168th of 244
70 · median 144
Started
2018
with 23 others
No phase
110 of 376
32 open now
Registered
164th of 376
by date

Among the 376 studies in Multiple Sclerosis with a site in France, this one is the 168th largest by enrollment of the 244 interventional ones that give a count, is one of 24 that started in 2018, is one of 110 with no phase, and was the 164th registered.

Multiple Sclerosis

3,267 studies on the registry are indexed under Multiple Sclerosis; 662 are open to participants now.

Browse Multiple Sclerosis studies →

Open to participants now

64 of the 376 studies in Multiple Sclerosis with a site in France are open now. Recruiting first, the newest first:

59 more — sign in →

All 64 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

03

Conditions studied

  • Multiple Sclerosis
  • Respiration Disorders
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • prior to any study procedure

Exclusion criteria

Exclusion Criteria:

  • Any severe (III or IV)
  • Pregnancy or woman with
  • to MRI
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Other
    Patients with severe MS

    polysomnography and functional pulmonary testings.

    Diagnostic Test: Polysomnography

Interventions

  • Diagnostic testPolysomnography

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

    Also known as: functional pulmonary testings

06

What researchers measure

Primary outcomes

  1. Polysomnography

    presence of phasic activation of respiratory muscles

    Time frame: Baseline only_during one night

Secondary outcomes

  1. Respiratory function testing

    difference between vital capacity upright and supine position (liter)

    Time frame: Baseline only

  2. Respiratory function testing

    maximal inspiratory pressure (mmHg)

    Time frame: Baseline only

  3. Respiratory function testing

    maximal expiratory pressure (mmHg)

    Time frame: Baseline only

  4. Respiratory function testing

    SNIP (mmHg)

    Time frame: Baseline only

  5. Respiratory function testing

    peak flow (liter)

    Time frame: Baseline only

  6. Cerebral and cervical spine MRI

    cerebral : 3DT1MPRAGE, T2 FLAIR, DWI / spine: 3DT1MPRAGE, axial T2 MEDIC, T2-WSPACE

    Time frame: Baseline only

  7. Expanded Disability Status Scale (EDSS)

    Neurological assessment of disability related to multiple sclerosis, total score from 0 to 10

    Time frame: Baseline only

  8. BICAMS

    Brief International Assessment for Multiple Sclerosis

    Time frame: Baseline only

07

Study locations

1 site
  • Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière
    Paris, Paris 75013, France
08

References and documents

Publications

  • 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. PubMed 33538688 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Nov 2020, 33 months.

Of 848 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's 33 months is above that.

Counting every sponsor, half of 870 studies reached it within 21 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2017
First posted
Nov 13, 2017
StartActual
Jan 11, 2018
Primary completionActual
Nov 6, 2020
CompletionActual
Nov 6, 2020
Last update
Dec 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03339817
Responsible party
Sponsor
First posted
Nov 13, 2017
Start date
Jan 11, 2018
Primary completion
Nov 6, 2020
Completion
Nov 6, 2020
Last update
Dec 10, 2025

Study contacts

Maillart Elisabeth, MD
principal investigator · Hopital de la Pitié Salpétrière

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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