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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04563832




Registration number
NCT04563832
Ethics application status
Date submitted
1/05/2020
Date registered
21/09/2020
Date last updated
21/09/2020

Titles & IDs
Public title
Self-administered Hyperinsufflation Chest Mobilization Randomized Study on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
Scientific title
Self-administered Hyperinsufflation Chest Mobilization Randomized Study on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
Secondary ID [1] 0 0
APHP2020
Universal Trial Number (UTN)
Trial acronym
MS-COUGH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Standardized respiratory management program
Other interventions - CoughAssist

Other: Control group - standardized respiratory management.

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 interventions: Standardized respiratory management program
Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years

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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Effect of COUGH-ASSIST on slowing the decline in respiratory function, - This will be demonstrated by monitoring respiratory function by spirometry
Timepoint [1] 0 0
12 months and 24 months
Secondary outcome [2] 0 0
Functional effectiveness of COUGH-ASSIST - By using the goal attainmentscaling method (GAS)
Timepoint [2] 0 0
12 months and 24 months
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Effectiveness of COUGH-ASSIST in reducing the risk of serious respiratory infection - This will be evaluate by the number of serious respiratory infection
Timepoint [4] 0 0
24 months

Eligibility
Key inclusion criteria
- Confirmed MS diagnosis (McDonald criteria)

- EDSS ≥ 7

- Age greater than or equal to 18 years.

- Expiratory flow during a coughing effort (DEPtoux) Ë‚4.5L / s.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Assistance Publique - Hôpitaux de Paris
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT04563832
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jonathan LEVY, Dr
Address 0 0
Country 0 0
Phone 0 0
+33 147107900
Fax 0 0
Email 0 0
jonathan.levy2@aphp.fr
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04563832