Multiple SclerosisMS-COUGHNCT04563832
Self-administered Hyperinsufflation Chest on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
A study testing Standardized respiratory management program and CoughAssist in people with Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In patients with neuromuscular disease, chest mobilization by hyperinsufflation slows respiratory decline by almost 80% compared to controls, and prevents complications like pneumonia, atelectasis and respiratory distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Standardized respiratory management program and CoughAssist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2021to Oct 2022
- 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
- Confirmed MS diagnosis (McDonald criteria)
- EDSS ≥ 7
- Age greater than or equal to 18 years.
- Expiratory flow during a coughing effort (DEPtoux) ˂4.5L / s.
Who cannot join
- ENT and / or thoracic surgery less than 6 months old
- Progressive or past pneumothorax / pneumomediastinum
- Severe swallowing disorders.
- Inability to use the device under study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Raymond Poincaré
Garches, Haut de Seine, 92380
Jonathan LEVY, Dr, 01.4710.70.60
About this study
Official title: Self-administered Hyperinsufflation Chest Mobilization Randomized Study on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
In patients with neuromuscular disease, chest mobilization by hyperinsufflation slows respiratory decline by almost 80% compared to controls, and prevents complications like pneumonia, atelectasis and respiratory distress.
This insufflation technique improves the airway clearance and reduces the need for invasive ventilation. It also improves CV and DEPtoux in patients with neuromuscular pathology
Read the detailed description
During multiple sclerosis (MS), although expiratory involvement and reduced sputum capacity are predominant, automated techniques of hyperinsufflation and in-exsufflation remain underused and undervalued. A single retrospective study suggests a decrease in the decline in respiratory function with regular manual hyperinsufflation.
Evidence of a benefit of chest mobilization by hyperinsufflation by a controlled trial is therefore necessary before recommending its use in MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Standardized respiratory management program, CoughAssist
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized respiratory management programOther
Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years
CoughAssistOther
self-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | standardized respiratory management. Receives: Other: Standardized respiratory management program |
| Experimental group | Experimental | same program as control group associated with the daily use of a hyperinsufflation technique (2 times per day during15 minutes, 5 days a week, for 2 years) Receives: Other: Standardized respiratory management program; Other: CoughAssist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of a self-administered automated hyperinsufflation technique for 2 years, versus standard management, on respiratory infection risk within 2 years after randomization, in patients with MS.
This will be evaluated by the incidence of lower respiratory infections requiring antibiotic therapy
Measured: 24 months
Secondary outcomes (4)
Effect of COUGH-ASSIST on slowing the decline in respiratory function,
This will be demonstrated by monitoring respiratory function by spirometry
Measured: 12 months and 24 months
Functional effectiveness of COUGH-ASSIST
By using the goal attainmentscaling method (GAS)
Measured: 12 months and 24 months
Tolerance and compliance with COUGH-ASSIST,
This will be evaluated via an online "patient reported outcomes form" and data readings from the internal memory of the COUGH-ASSIST
Measured: 24 months
Effectiveness of COUGH-ASSIST in reducing the risk of serious respiratory infection
This will be evaluate by the number of serious respiratory infection
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start25 Nov 2021
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Control group: standardized respiratory management. * Experimental group: same program, associated with the daily use of a hyperinsufflation technique.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563832
- Sponsor's protocol ID
- APHP2020
- Acronym
- MS-COUGH
- Status last verified
- Apr 2021
- First submitted
- 21 Sep 2020
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-administered Hyperinsufflation Chest Mobilization Randomized Study on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
- ClinicalTrials.gov ID
- NCT04563832
- Acronym / sponsor ID
- MS-COUGH / APHP2020
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 24 Sep 2020 (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.
In patients with neuromuscular disease, chest mobilization by hyperinsufflation slows respiratory decline by almost 80% compared to controls, and prevents complications like pneumonia, atelectasis and respiratory distress.
This insufflation technique improves the airway clearance and reduces the need for invasive ventilation. It also improves CV and DEPtoux in patients with neuromuscular pathology
Detailed description
During multiple sclerosis (MS), although expiratory involvement and reduced sputum capacity are predominant, automated techniques of hyperinsufflation and in-exsufflation remain underused and undervalued. A single retrospective study suggests a decrease in the decline in respiratory function with regular manual hyperinsufflation.
Evidence of a benefit of chest mobilization by hyperinsufflation by a controlled trial is therefore necessary before recommending its use in MS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Control group: standardized respiratory management. * Experimental group: same program, associated with the daily use of a hyperinsufflation technique.
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Standardized respiratory management programstandardized respiratory management. |
| Experimental group | Experimental | Other: Standardized respiratory management program, Other: CoughAssistsame program as control group associated with the daily use of a hyperinsufflation technique (2 times per day during15 minutes, 5 days a week, for 2 years) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed MS diagnosis (McDonald criteria)
- EDSS ≥ 7
- Age greater than or equal to 18 years.
- Expiratory flow during a coughing effort (DEPtoux) ˂4.5L / s.
Key exclusion criteria (4 listed)
- ENT and / or thoracic surgery less than 6 months old
- Progressive or past pneumothorax / pneumomediastinum
- Severe swallowing disorders.
- Inability to use the device under study
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 |
|---|---|---|
| Standardized respiratory management programBronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years | Other | Control group, Experimental group |
| CoughAssistself-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years) | Other | Experimental group |
Primary outcome
Effectiveness of a self-administered automated hyperinsufflation technique for 2 years, versus standard management, on respiratory infection risk within 2 years after randomization, in patients with MS.
Time frame: 24 months
This will be evaluated by the incidence of lower respiratory infections requiring antibiotic therapy
4 secondary outcomes
Effect of COUGH-ASSIST on slowing the decline in respiratory function,
Time frame: 12 months and 24 months
Functional effectiveness of COUGH-ASSIST
Time frame: 12 months and 24 months
Tolerance and compliance with COUGH-ASSIST,
Time frame: 24 months
Effectiveness of COUGH-ASSIST in reducing the risk of serious respiratory infection
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized respiratory management program and CoughAssist in people with Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris 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 4 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: status not confirmed, as of the sponsor's last update on 12 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan LEVY, Dr (+33 147107900, jonathan.levy2@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of a self-administered automated hyperinsufflation technique for 2 years, versus standard management, on respiratory infection risk within 2 years after randomization, in patients with MS. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.