Neuromuscular DiseaseCOUGHELPNCT02137304
A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases
A study testing Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) in people with Neuromuscular Disease, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
The investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Disease
- What is being tested?
- Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2014to 8 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- man or female age18 years
- neuromuscular disease
- coughassist adaptation treatment
- peak cough flow<270liter/minute
Who cannot join
- acute organ failure
- insufflation contrindication
- pregnant women/no affiliation to a social security scheme
- plan of legal protection
Trial locations and contacts
1 site in 1 country.
About this study
The investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.
Read the detailed description
he investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.
- Conditions
- Neuromuscular Disease
- Being tested
- Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)
- Keywords
- cough help, in-exsufflation, neuromuscular disease, cough assistance optimization, efficient cough flow
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)Device
Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) mechanical insufflation to increase peak cough flow
| Study group | Role | What they receive |
|---|---|---|
| neuromuscular patients | Experimental | Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) Receives: Device: Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
optimal negative pressure treshold value
Optimal negative pressure treshold value measured for a flow superior or equal to 160 liter/minute and 270 liter/minute
Measured: 20 minutes
Secondary outcomes (2)
optimal pressure treshold based on the best peak flow.
Measured: 10 minutes
volume-flow curve aspect
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study start4 Feb 2014
- Primary completion8 Sep 2017
- Study completion8 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic LOFASO, Pr, Principal investigator, AP-HP Hopital R. Poincaré Garches
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137304
- Sponsor's protocol ID
- 2013-A01771-44
- Acronym
- COUGHELP
- Status last verified
- Nov 2017
- First submitted
- 17 Apr 2014
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lacombe M, Bore A, Amo Castrillo LD, Boussaid G, Falaize L, Vlachos E, Orlikowski D, Prigent H, Lofaso F. Peak Cough Flow Fails to Detect Upper Airway Collapse During Negative Pressure Titration for Cough-Assist. Arch Phys Med Rehabil. 2019 Dec;100(12):2346-2353. doi: 10.1016/j.apmr.2019.06.012. Epub 2019 Jul 24.
PubMed 31351076
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases
- ClinicalTrials.gov ID
- NCT02137304
- Acronym / sponsor ID
- COUGHELP / 2013-A01771-44
- Conditions
- Neuromuscular Disease
- Keywords
- cough help, in-exsufflation, neuromuscular disease, cough assistance optimization, efficient cough flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 4 Feb 2014 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.
Detailed description
he investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neuromuscular patients | Experimental | Device: Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- man or female age18 years
- neuromuscular disease
- coughassist adaptation treatment
- peak cough flow<270liter/minute
Key exclusion criteria (4 listed)
- acute organ failure
- insufflation contrindication
- pregnant women/no affiliation to a social security scheme
- plan of legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) mechanical insufflation to increase peak cough flow | Device | neuromuscular patients |
Primary outcome
optimal negative pressure treshold value
Time frame: 20 minutes
Optimal negative pressure treshold value measured for a flow superior or equal to 160 liter/minute and 270 liter/minute
2 secondary outcomes
optimal pressure treshold based on the best peak flow.
Time frame: 10 minutes
volume-flow curve aspect
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Derived from this study: PubMed 31351076Lacombe M, Bore A, Amo Castrillo LD, Boussaid G, Falaize L, Vlachos E, Orlikowski D, Prigent H, Lofaso F. Peak Cough Flow Fails to Detect Upper Airway Collapse During Negative Pressure Titration for Cough-Assist. Arch Phys Med Rehabil. 2019 Dec;100(12):2346-2353. doi: 10.1016/j.apmr.2019.06.012. Epub 2019 Jul 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic LOFASO, Pr principal investigator
AP-HP Hopital R. Poincaré Garches
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) in people with Neuromuscular Disease, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optimal negative pressure treshold value (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02137304, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.