Multiple Sclerosis
Conditions
Brief 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. 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.
Interventions
OTHERStandardized respiratory management program
Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years
OTHERCoughAssist
self-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years)
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
* Control group: standardized respiratory management. * Experimental group: same program, associated with the daily use of a hyperinsufflation technique.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 24 months | This will be evaluated by the incidence of lower respiratory infections requiring antibiotic therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of COUGH-ASSIST on slowing the decline in respiratory function, | 12 months and 24 months | This will be demonstrated by monitoring respiratory function by spirometry |
| Functional effectiveness of COUGH-ASSIST | 12 months and 24 months | By using the goal attainmentscaling method (GAS) |
| Tolerance and compliance with COUGH-ASSIST, | 24 months | This will be evaluated via an online patient reported outcomes form and data readings from the internal memory of the COUGH-ASSIST |
| Effectiveness of COUGH-ASSIST in reducing the risk of serious respiratory infection | 24 months | This will be evaluate by the number of serious respiratory infection |
Countries
France
Contacts
Primary ContactJonathan LEVY, Dr
Backup ContactHélène PRIGENT, Pr
Outcome results
None listed