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

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standardized respiratory management program
CoughAssist
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Raymond PoincaréRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control group

Experimental group

Arm Description

standardized respiratory management.

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect of COUGH-ASSIST on slowing the decline in respiratory function,
This will be demonstrated by monitoring respiratory function by spirometry
Functional effectiveness of COUGH-ASSIST
By using the goal attainmentscaling method (GAS)
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
Effectiveness of COUGH-ASSIST in reducing the risk of serious respiratory infection
This will be evaluate by the number of serious respiratory infection

Full Information

First Posted
September 21, 2020
Last Updated
April 11, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04563832
Brief Title
Self-administered Hyperinsufflation Chest on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group: standardized respiratory management. Experimental group: same program, associated with the daily use of a hyperinsufflation technique.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
standardized respiratory management.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Standardized respiratory management program
Intervention Description
Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years
Intervention Type
Other
Intervention Name(s)
CoughAssist
Intervention Description
self-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years)
Primary Outcome Measure Information:
Title
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.
Description
This will be evaluated by the incidence of lower respiratory infections requiring antibiotic therapy
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Effect of COUGH-ASSIST on slowing the decline in respiratory function,
Description
This will be demonstrated by monitoring respiratory function by spirometry
Time Frame
12 months and 24 months
Title
Functional effectiveness of COUGH-ASSIST
Description
By using the goal attainmentscaling method (GAS)
Time Frame
12 months and 24 months
Title
Tolerance and compliance with COUGH-ASSIST,
Description
This will be evaluated via an online "patient reported outcomes form" and data readings from the internal memory of the COUGH-ASSIST
Time Frame
24 months
Title
Effectiveness of COUGH-ASSIST in reducing the risk of serious respiratory infection
Description
This will be evaluate by the number of serious respiratory infection
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan LEVY, Dr
Phone
+33 147107900
Email
jonathan.levy2@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène PRIGENT, Pr
Phone
+33 147107900
Email
helene.prigent@aphp.fr
Facility Information:
Facility Name
Hôpital Raymond Poincaré
City
Garches
State/Province
Haut De Seine
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan LEVY, Dr
Phone
01.4710.70.60

12. IPD Sharing Statement

Learn more about this trial

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

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