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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | standardized respiratory management. |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized respiratory management program | Other | Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of COUGH-ASSIST on slowing the decline in respiratory function, | This will be demonstrated by monitoring respiratory function by spirometry | 12 months and 24 months |
| Functional effectiveness of COUGH-ASSIST |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan LEVY, Dr | Contact | +33 147107900 | jonathan.levy2@aphp.fr | |
| Hélène PRIGENT, Pr | Contact | +33 147107900 | helene.prigent@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Raymond Poincaré | Recruiting | Garches | Haut de Seine | 92380 | France |
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| CoughAssist | Other | self-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years) |
|
By using the goal attainmentscaling method (GAS)
| 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 | 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 | 24 months |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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