Multiple SclerosisRespiMuSNCT03339817
Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère
A study testing Polysomnography in people with Multiple Sclerosis and Respiration Disorders, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Respiration Disorders
- What is being tested?
- Polysomnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2018to 6 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any severe Chronic Obstructive Pulmonary Disease (III or IV)
- Pregnancy or woman with childbearing potential
- contraindication to MRI
Trial locations and contacts
1 site in 1 country.
France1 site
Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière
Paris, Paris, 75013
About this study
The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5).
- Conditions
- Multiple Sclerosis, Respiration Disorders
- Being tested
- Polysomnography
- Medical subject headings
- Multiple Sclerosis, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDiagnostic test
Also called functional pulmonary testings
During polysomnographia and functional pulmonary testing, signs of diaphragmatic dysfunction responsible for respiratory disorders will be searched.
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe MS | Other | polysomnography and functional pulmonary testings. Receives: Diagnostic Test: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography
presence of phasic activation of respiratory muscles
Measured: Baseline only_during one night
Secondary outcomes (8)
Respiratory function testing
difference between vital capacity upright and supine position (liter)
Measured: Baseline only
Respiratory function testing
maximal inspiratory pressure (mmHg)
Measured: Baseline only
Respiratory function testing
maximal expiratory pressure (mmHg)
Measured: Baseline only
Respiratory function testing
SNIP (mmHg)
Measured: Baseline only
Respiratory function testing
peak flow (liter)
Measured: Baseline only
Cerebral and cervical spine MRI
cerebral : 3DT1MPRAGE, T2 FLAIR, DWI / spine: 3DT1MPRAGE, axial T2 MEDIC, T2-WSPACE
Measured: Baseline only
Expanded Disability Status Scale (EDSS)
Neurological assessment of disability related to multiple sclerosis, total score from 0 to 10
Measured: Baseline only
BICAMS
Brief International Assessment for Multiple Sclerosis
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start11 Jan 2018
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Maillart Elisabeth, MD, Principal investigator, Hopital de la Pitié Salpétrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339817
- Sponsor's protocol ID
- C16-111
- Other IDs
- 2017-A01845-48
- Acronym
- RespiMuS
- Status last verified
- Mar 2025
- First submitted
- 31 Oct 2017
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère
- ClinicalTrials.gov ID
- NCT03339817
- Acronym / sponsor ID
- RespiMuS / C16-111
- Conditions
- Multiple Sclerosis, Respiration Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe MS | Other | Diagnostic Test: Polysomnographypolysomnography and functional pulmonary testings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Any severe Chronic Obstructive Pulmonary Disease (III or IV)
- Pregnancy or woman with childbearing potential
- contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyAlso: functional pulmonary testingsDuring polysomnographia and functional pulmonary testing, signs of diaphragmatic dysfunction responsible for respiratory disorders will be searched. | Diagnostic test | Patients with severe MS |
Primary outcome
Polysomnography
Time frame: Baseline only_during one night
presence of phasic activation of respiratory muscles
8 secondary outcomes
Respiratory function testing
Time frame: Baseline only
Respiratory function testing
Time frame: Baseline only
Respiratory function testing
Time frame: Baseline only
Respiratory function testing
Time frame: Baseline only
Respiratory function testing
Time frame: Baseline only
Cerebral and cervical spine MRI
Time frame: Baseline only
Expanded Disability Status Scale (EDSS)
Time frame: Baseline only
BICAMS
Time frame: Baseline only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 33538688Zeidan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maillart Elisabeth, MD principal investigator
Hopital de la Pitié Salpétrière
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography in people with Multiple Sclerosis and Respiration Disorders, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polysomnography (time frame: Baseline only_during one night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03339817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.