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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04563832
Ethics application status
Date submitted
21/09/2020
Date registered
24/09/2020
Date last updated
12/04/2022

Titles & IDs
Public title
Self-administered Hyperinsufflation Chest 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.
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Effect of COUGH-ASSIST on slowing the decline in respiratory function,
Timepoint [1] 0 0
12 months and 24 months
Secondary outcome [2] 0 0
Functional effectiveness of COUGH-ASSIST
Timepoint [2] 0 0
12 months and 24 months
Secondary outcome [3] 0 0
Tolerance and compliance with 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
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) ?4.5L / s.
Minimum age
18 Years
Maximum age
No limit
Sex
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
Other
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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2022
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Haut De Seine

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04563832