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

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

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Standardized respiratory management program; Other: CoughAssist

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 Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan LEVY, Dr; Phone Number: +33 147107900; Email: jonathan.levy2@aphp.fr
• Study Contact Backup: Name: Hélène PRIGENT, Pr; Phone Number: +33 147107900; Email: helene.prigent@aphp.fr

Study Locations

• France
  • Haut De Seine
    • Garches, Haut De Seine, France, 92380
      • Recruiting
      • Hôpital Raymond Poincaré
      • Contact: Jonathan LEVY, Dr; Phone Number: 01.4710.70.60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 25, 2021
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (ACTUAL): September 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Infections; Respiratory Tract Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Respiratory Tract Infections
• Other Study ID Numbers: APHP2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No