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

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Other: Standardized respiratory management program; Other: CoughAssist

• Registration Number: NCT04563832
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-24
• Status Verified: 2021-04
• Study Start: 2021-11-25
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-12
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Standardized respiratory management program	standardized respiratory management.
Experimental group	Standardized respiratory management program	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)
Experimental group	CoughAssist	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Functional effectiveness of COUGH-ASSIST	12 months and 24 months	By using the goal attainmentscaling method (GAS)
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
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

Trial Locations

Locations (1)

Hôpital Raymond Poincaré; 🇫🇷 Garches, Haut De Seine, France