Self-administered Hyperinsufflation Chest on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Self-administered Hyperinsufflation Chest Mobilization Randomized Study on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Standardized respiratory management program
* Other: CoughAssist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control group: standardized respiratory management. Experimental group: same program, associated with the daily use of a hyperinsufflation technique.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>standardized respiratory management. | Other: Standardized respiratory management program<br>* Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years<br>|
| Experimental: Experimental group<br>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) | Other: Standardized respiratory management program<br>* Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years<br>Other: CoughAssist<br>* self-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |