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

NCT04563832 | Unknown

• 1 other identifier: APHP2020
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Effect of COUGH-ASSIST on slowing the decline in respiratory function,

  12 months and 24 months

• Functional effectiveness of COUGH-ASSIST

  12 months and 24 months

• Tolerance and compliance with COUGH-ASSIST,

  24 months

• Effectiveness of COUGH-ASSIST in reducing the risk of serious respiratory infection

  24 months

Study Arms (2)

Control group

OTHER

standardized respiratory management.

Other: Standardized respiratory management program

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)

Other: Standardized respiratory management program; Other: CoughAssist

Interventions

Standardized respiratory management program OTHER

Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years

Control group; Experimental group

CoughAssist OTHER

self-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years)

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Raymond Poincaré

Garches, Haut de Seine, 92380, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Jonathan LEVY, Dr

CONTACT

+33 147107900; jonathan.levy2@aphp.fr

Hélène PRIGENT, Pr

CONTACT

+33 147107900; helene.prigent@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Control group: standardized respiratory management. * Experimental group: same program, associated with the daily use of a hyperinsufflation technique.

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 24, 2020
• Study Start: November 25, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 12, 2022

Record last verified: 2021-04

Locations

FR (1)