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

Multiple Sclerosis Clinical Trial

— MS-COUGH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04563832
• Other study ID #: APHP2020
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2021
• Est. completion date: October 2022

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jonathan LEVY, Dr
• Phone: +33 147107900
• Email: jonathan.levy2[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Respiratory Tract Infections
• Sclerosis

Intervention

Other:
• Standardized respiratory management program
Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years
• CoughAssist
self-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years)

Locations

Country	Name	City	State
France	Hôpital Raymond Poincaré	Garches	Haut De Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Functional effectiveness of COUGH-ASSIST	By using the goal attainmentscaling method (GAS)	12 months and 24 months
Secondary	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
Secondary	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