Neuromuscular DiseaseOPTICOUGHNCT01518439
Instrumental and Manual Increase of Couch in Neuromuscular Patients
A study testing Alpha 200®, Alpha 200® + physiotherapist and Cough Assist® in people with Neuromuscular Disease and Chronic Respiratory Failure, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Inefficient cough is responsible of respiratory complications in neuromuscular patients which can lead to hospitalisation and can be life threatening. Techniques enhancing cough efficiency are successful in improving the clearance of bronchial secretions and help non invasive ventilation efficiency especially in case… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Disease, Chronic Respiratory Failure, Coughing
- What is being tested?
- Alpha 200®, Alpha 200® + physiotherapist and Cough Assist®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Jul 2013
- 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
- adult patients
- neuromuscular disorders with a respiratory restrictive syndrome (VC < 40% and/or cough flow < 180 L/min and/or Pe max < 40 cmH2O)
- non invasive ventilation
- stable respiratory state > 1 month before inclusion
- signed informed consent form
Who cannot join
- unstable respiratory state with increased bronchial secretions
- unstable hemodynamics
- pneumothorax and or emphysema
- tracheostomy
- major bulbar involvement with swallowing dysfunction with the liquids
- Persons under Guardianship or Trusteeship
Show all 9Show fewer
- Pregnant women
- not covered by the social security system
- refusal of study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Instrumental and Manual Increase of Couch in Neuromuscular Patients: Effects of Different Techniques on the Generated Flow
Inefficient cough is responsible of respiratory complications in neuromuscular patients which can lead to hospitalisation and can be life threatening. Techniques enhancing cough efficiency are successful in improving the clearance of bronchial secretions and help non invasive ventilation efficiency especially in case of acute respiratory failure. Combining mechanical exsufflation to the manual techniques of physiotherapy might enhance efficiency. Therefore the investigators want to compare cough efficiency under different techniques of instrumental and manual of cough assistance in order to determine the best combination to optimize cough flow.
Read the detailed description
Hypothesis: Cough inefficiency in neuromuscular patients increases morbidity and mortality in case of airway infections and may lead to invasive ventilation. The use of techniques enhancing cough have been successful in improving the success of non invasive ventilation. We want to determine whether adding manual physiotherapist techniques to mechanical exsufflation improve cough efficiency and its ability to clear bronchial secretions.
Objectives: To compare cough flows obtained with different combination of the use of increased inspiratory capacity technique, mechanical insufflation-exsufflation technique and manually applied pressures techniques.
Method:open monocentric cross-over study (the patients are their own controls). Five combinations of cough increase techniques are compared Inclusion criteria: adult neuromuscular patients with a cough inefficiency at a stable state upon inclusion.
As this is a pilot study, 20 patients from the home ventilation unit of the intensive care of the Raymond Poincare teaching hospital (Garches, France) will be included during the usual follow-up of chronic respiratory failure.
- Conditions
- Neuromuscular Disease, Chronic Respiratory Failure, Coughing
- Being tested
- Alpha 200®, Alpha 200® + physiotherapist, Cough Assist®, Cough Assist® + physiotherapist, physiotherapist
- Keywords
- neuromuscular, cough, restrictive
- Medical subject headings
- Neuromuscular Diseases, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha 200®Device
inspiratory capacity is increased with the use of constant pressure device: Alpha 200®
Alpha 200® + physiotherapistDevice
inspiratory capacity is increased with the use of constant pressure device (Alpha 200®) combined with the manual pressures techniques to increase cough by the physiotherapist
Cough Assist®Device
increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®)
Cough Assist® + physiotherapistDevice
increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®) combined with the manual pressures techniques to increase cough by the physiotherapist
physiotherapistOther
manual pressures techniques to increase cough applied by the physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| neuromuscular patients | Experimental | neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion Receives: Device: Alpha 200®; Device: Alpha 200® + physiotherapist; Device: Cough Assist®; Device: Cough Assist® + physiotherapist; Other: physiotherapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
cough flow obtained from the combination of mechanical and manual cough assistance techniques
Measured: 2 Hours
Secondary outcomes (4)
duration of efficient cough flow (above 180 l/min)under each cough assistance technique
Measured: 2 Hours
respiratory comfort
evaluation with a visual analogical scale
Measured: 2 Hours
subjective evaluation of cough efficiency
evaluation with a visual analogical scale
Measured: 2 Hours
Respiratory comfort
evaluation with the Borg dyspnea scale
Measured: 2 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2012
- Study completionJul 2013
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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Adep Assistance
- Responsible party
- Sponsor
- Investigators
- Frederic Lofaso, Md-PhD, Study director, University of VersaillesHelene Prigent, MD-PhD, Principal investigator, University of Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518439
- Sponsor's protocol ID
- 2011-A00879-32
- Acronym
- OPTICOUGH
- Status last verified
- Jul 2013
- First submitted
- 11 Jan 2012
- Last updated
- 19 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Morrow B, Argent A, Zampoli M, Human A, Corten L, Toussaint M. Cough augmentation techniques for people with chronic neuromuscular disorders. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013170. doi: 10.1002/14651858.CD013170.pub2.
PubMed 33887060
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrumental and Manual Increase of Couch in Neuromuscular Patients: Effects of Different Techniques on the Generated Flow
- ClinicalTrials.gov ID
- NCT01518439
- Acronym / sponsor ID
- OPTICOUGH / 2011-A00879-32
- Conditions
- Neuromuscular Disease, Chronic Respiratory Failure, Coughing
- Keywords
- neuromuscular, cough, restrictive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Adep Assistance
- Study start
- Jan 2012
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Jan 2012 (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.
Inefficient cough is responsible of respiratory complications in neuromuscular patients which can lead to hospitalisation and can be life threatening. Techniques enhancing cough efficiency are successful in improving the clearance of bronchial secretions and help non invasive ventilation efficiency especially in case of acute respiratory failure. Combining mechanical exsufflation to the manual techniques of physiotherapy might enhance efficiency. Therefore the investigators want to compare cough efficiency under different techniques of instrumental and manual of cough assistance in order to determine the best combination to optimize cough flow.
Detailed description
Hypothesis: Cough inefficiency in neuromuscular patients increases morbidity and mortality in case of airway infections and may lead to invasive ventilation. The use of techniques enhancing cough have been successful in improving the success of non invasive ventilation. We want to determine whether adding manual physiotherapist techniques to mechanical exsufflation improve cough efficiency and its ability to clear bronchial secretions.
Objectives: To compare cough flows obtained with different combination of the use of increased inspiratory capacity technique, mechanical insufflation-exsufflation technique and manually applied pressures techniques.
Method:open monocentric cross-over study (the patients are their own controls). Five combinations of cough increase techniques are compared Inclusion criteria: adult neuromuscular patients with a cough inefficiency at a stable state upon inclusion.
As this is a pilot study, 20 patients from the home ventilation unit of the intensive care of the Raymond Poincare teaching hospital (Garches, France) will be included during the usual follow-up of chronic respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neuromuscular patients | Experimental | Device: Alpha 200®, Device: Alpha 200® + physiotherapist, Device: Cough Assist®, Device: Cough Assist® + physiotherapist, Other: physiotherapistneuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients
- neuromuscular disorders with a respiratory restrictive syndrome (VC < 40% and/or cough flow < 180 L/min and/or Pe max < 40 cmH2O)
- non invasive ventilation
- stable respiratory state > 1 month before inclusion
- signed informed consent form
Key exclusion criteria (9 listed)
- unstable respiratory state with increased bronchial secretions
- unstable hemodynamics
- pneumothorax and or emphysema
- tracheostomy
- major bulbar involvement with swallowing dysfunction with the liquids
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 |
|---|---|---|
| Alpha 200®inspiratory capacity is increased with the use of constant pressure device: Alpha 200® | Device | neuromuscular patients |
| Alpha 200® + physiotherapistinspiratory capacity is increased with the use of constant pressure device (Alpha 200®) combined with the manual pressures techniques to increase cough by the physiotherapist | Device | neuromuscular patients |
| Cough Assist®increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®) | Device | neuromuscular patients |
| Cough Assist® + physiotherapistincreased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®) combined with the manual pressures techniques to increase cough by the physiotherapist | Device | neuromuscular patients |
| physiotherapistmanual pressures techniques to increase cough applied by the physiotherapist | Other | neuromuscular patients |
Primary outcome
cough flow obtained from the combination of mechanical and manual cough assistance techniques
Time frame: 2 Hours
4 secondary outcomes
duration of efficient cough flow (above 180 l/min)under each cough assistance technique
Time frame: 2 Hours
respiratory comfort
Time frame: 2 Hours
subjective evaluation of cough efficiency
Time frame: 2 Hours
Respiratory comfort
Time frame: 2 Hours
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 19 Jul 2013.
- Derived from this study: PubMed 33887060Morrow B, Argent A, Zampoli M, Human A, Corten L, Toussaint M. Cough augmentation techniques for people with chronic neuromuscular disorders. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013170. doi: 10.1002/14651858.CD013170.pub2.
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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, Md-PhD study director
University of Versailles
Helene Prigent, MD-PhD principal investigator
University of Versailles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha 200®, Alpha 200® + physiotherapist and Cough Assist® in people with Neuromuscular Disease and Chronic Respiratory Failure, 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 5 inclusion and 9 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 19 Jul 2013. 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?
cough flow obtained from the combination of mechanical and manual cough assistance techniques (time frame: 2 Hours). 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 NCT01518439, 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 19 Jul 2013; AzTrials last refreshed its copy on 8 Nov 2026.