CoughMI-EcoachingNCT06190431
Does the Coaching Function Improve the Learning of Mechanical In-exsufflation (MI-E) in Paediatric Subjects?
A study testing Learning the use of an in-exsufflation device with the guidance of a physiotherapist and Using the coaching mode in people with Cough and Airway Clearance Impairment, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The use of mechanical insufflation-exsufflation (MI-E) in children with neuromuscular diseases (NMD) is recommended by international guidelines and societies and well documented. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough, Airway Clearance Impairment, Neuromuscular Diseases
- What is being tested?
- Learning the use of an in-exsufflation device with the guidance of a physiotherapist and Using the coaching mode
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Nov 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6-12 (F/M)
- Acceptance of consent (child + 2 parents)
- Non-smoker
- Speak and understand French
- Schooling in mainstream education
- Age 6-12 (F/M)
Show all 11Show fewer
- Acceptance of consent (child + 2 parents)
- Non-smoker
- Speak and understand French
- Patient with a neuromuscular disease
- Able to perform the MI-E maneuver
Who cannot join
- Comorbidities: congenital heart disease, chronic lung disease, immune deficiency, neuromuscular disease, neurological disease or multiple disabilities
- History or clinical signs of disease affecting lung function, recent lung infection, spinal or thoracic deformity.
- Part 2:
- Hemodynamic instability
- Current or recent pneumothorax
- Hemoptysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint Luc
Brussels, Brussels Capital, 1200
Nicolas Audag, Phd, 00327641621, nicolas.audag@saintluc.uclouvain.be
About this study
The use of mechanical insufflation-exsufflation (MI-E) in children with neuromuscular diseases (NMD) is recommended by international guidelines and societies and well documented. Many authors have shown that MI-E is safe and effective for airway clearance and has a significant benefit in reducing the duration of the airway clearance session in children with respiratory infections and atelectasis or in the postoperative period. However, its use in paediatrics is still poorly supervised and learning the technique is too often therapist- and/or patient-dependent. The use of a protocol or means of help to guide the initiation and learning of MI-E would allow better use, better adaptation of the settings and potentially better compliance with the treatment. The aim of this study is to test whether the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the technique compared to guidance alone.This randomized controlled study will first include healthy children, aged 6 to 12 years, with no history or recent respiratory infection affecting lung function or other chronic diseases. In a second phase, the investigators will test the use of the learning process in children with neuromuscular diseases. The investigators hope that the results of this study will provide a better framework for the learning and effectiveness of MI-E. Furthermore, if the results are positive, this will allow better support for the use of MI-E in chronic treatments and help to ensure that this costly treatment for hospitals and public health is used efficiently.
Read the detailed description
RATIONALE In the first part, the population will be composed of healthy children, in the second part, the investigators will include children with neuromuscular diseases. The two parts will follow the same process. The hypothesis is that the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the MI-E compared to guidance alone. The MI-E technique does not represent any documented risk in its use nor in its indication if the contraindications are respected (non-drained pneumothorax, hemoptysis and hemodynamic instability). Coaching modules (playful visual stimulation) have recently become available on MI-E devices. This experiment will allow us to judge their usefulness in teaching the use of MI-E in paediatric patients.
OBJECTIVES The aim of this study is to test whether the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the technique compared to guidance alone. This randomized controlled study will first include healthy children, aged 6 to 12 years. In a second phase, the investigators will test the use in children with neuromuscular diseases. For the process (common for the two parts), eligible subjects will be invited to perform, depending on randomization at the intervention 1 (physiotherapist guidance + coaching module) or the intervention 2 (physiotherapist guidance). The learning times, the coughing expiratory flow rate achieved and the synchronization between the subject and the machine will be compared between the two processes.
- Conditions
- Cough, Airway Clearance Impairment, Neuromuscular Diseases
- Being tested
- Learning the use of an in-exsufflation device with the guidance of a physiotherapist, Using the coaching mode
- Keywords
- Mechanical In-Exsufflation, Coaching, Cough Assistance, Pediatric
- Medical subject headings
- Cough, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning the use of an in-exsufflation device with the guidance of a physiotherapistOther
Learning to use an in-exsufflation device with the guidance of a physiotherapist
Using the coaching modeOther
Learning the use of an in-exsufflation device using a coaching mode (playful visual stimulation) in addition to guidance of a physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Only physiotherapist guidance | Active comparator | The aim of this study is to test whether the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the technique compared to guidance alone. Receives: Other: Learning the use of an in-exsufflation device with the guidance of a physiotherapist |
| Physiotherapist guidance + coaching module | Active comparator | The aim of this study is to test whether the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the technique compared to guidance alone. Receives: Other: Learning the use of an in-exsufflation device with the guidance of a physiotherapist; Other: Using the coaching mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
The investigators will measure the number of sets (n) needed by the subjects to achieve five quality voluntary coughs during the learning session.
Measured: A the end of the learning session (after maximum 15 minutes)
Effectiveness
The investigators will measure the time needed (sec) by the subjects to achieve five quality voluntary coughs during the learning session.
Measured: A the end of the learning (after maximum 15 minutes).
Secondary outcomes (8)
Peak cough flow measured with the device (L/min)
The peak cough flow reached with the In-exsufflation device will be reported
Measured: During the learning session (max 15 minutes)
Peak cough flow measured with the device (L/min)
The peak cough flow reached with the In-exsufflation device will be reported
Measured: During the session on the second day (24 hours after the learning session)
Visual analog scales (VAS) "ease of use" (0-10)
Children will be assessed about the ease of the learning
Measured: At the end of the learning session (max 15 minutes)
Visual analog scales (VAS) "ease of use" (0-10)
Children will be assessed about the ease of the learning
Measured: At the end of the session on the second day (24 hours after the learning session)
Visual analog scales (VAS) "comfort" (0-10)
Children will be assessed about the comfort of the procedure
Measured: At the end of the learning session (max 15 minutes)
Visual analog scales (VAS) "comfort" (0-10)
Children will be assessed about the comfort of the procedure
Measured: At the end of the session on the second day (24 hours after the learning session)
the number of sets (n)
The investigators will measure the number of sets (n) needed by the subjects to achieve five Quality voluntary coughs one day after the first session.
Measured: At the end of the session on the second day (24 hours after the learning session)
the time (sec) needed by the subjects to achieve five Quality voluntary coughs
The investigators will measure the time (sec) needed by the subjects to achieve five Quality voluntary coughs one day after the learning session.
Measured: At the end of the session on the second day (24 hours after the learning session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start20 Nov 2023
- Primary completion20 Jan 2024
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CoughStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Audag, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190431
- Sponsor's protocol ID
- MI-E coaching project
- Acronym
- MI-Ecoaching
- Status last verified
- May 2026
- First submitted
- 8 Dec 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Panitch HB. Respiratory Implications of Pediatric Neuromuscular Disease. Respir Care. 2017 Jun;62(6):826-848. doi: 10.4187/respcare.05250.
PubMed 28546380Miske LJ, McDonough JM, Weiner DJ, Panitch HB. Changes in gastric pressure and volume during mechanical in-exsufflation. Pediatr Pulmonol. 2013 Aug;48(8):824-9. doi: 10.1002/ppul.22671. Epub 2012 Sep 4.
PubMed 22949331Hov B, Andersen T, Toussaint M, Mikalsen IB, Vollsaeter M, Markussen H, Indrekvam S, Hovland V. User-perceived impact of long-term mechanical assisted cough in paediatric neurodisability. Dev Med Child Neurol. 2023 May;65(5):655-663. doi: 10.1111/dmcn.15543. Epub 2023 Feb 14.
PubMed 36787316Hull J, Aniapravan R, Chan E, Chatwin M, Forton J, Gallagher J, Gibson N, Gordon J, Hughes I, McCulloch R, Russell RR, Simonds A. British Thoracic Society guideline for respiratory management of children with neuromuscular weakness. Thorax. 2012 Jul;67 Suppl 1:i1-40. doi: 10.1136/thoraxjnl-2012-201964. No abstract available.
PubMed 22730428Hov B, Andersen T, Toussaint M, Vollsaeter M, Mikalsen IB, Indrekvam S, Hovland V. Prevalence of long-term mechanical insufflation-exsufflation in children with neurological conditions: a population-based study. Dev Med Child Neurol. 2021 May;63(5):537-544. doi: 10.1111/dmcn.14797. Epub 2021 Jan 3.
PubMed 33393110
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Coaching Function Improve the Learning of Mechanical In-exsufflation (MI-E) in Paediatric Subjects?
- ClinicalTrials.gov ID
- NCT06190431
- Acronym / sponsor ID
- MI-Ecoaching / MI-E coaching project
- Conditions
- Cough, Airway Clearance Impairment, Neuromuscular Diseases
- Keywords
- Mechanical In-Exsufflation, Coaching, Cough Assistance, Pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 5 Jan 2024 (actual)
- 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 use of mechanical insufflation-exsufflation (MI-E) in children with neuromuscular diseases (NMD) is recommended by international guidelines and societies and well documented. Many authors have shown that MI-E is safe and effective for airway clearance and has a significant benefit in reducing the duration of the airway clearance session in children with respiratory infections and atelectasis or in the postoperative period. However, its use in paediatrics is still poorly supervised and learning the technique is too often therapist- and/or patient-dependent. The use of a protocol or means of help to guide the initiation and learning of MI-E would allow better use, better adaptation of the settings and potentially better compliance with the treatment. The aim of this study is to test whether the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the technique compared to guidance alone.This randomized controlled study will first include healthy children, aged 6 to 12 years, with no history or recent respiratory infection affecting lung function or other chronic diseases. In a second phase, the investigators will test the use of the learning process in children with neuromuscular diseases. The investigators hope that the results of this study will provide a better framework for the learning and effectiveness of MI-E. Furthermore, if the results are positive, this will allow better support for the use of MI-E in chronic treatments and help to ensure that this costly treatment for hospitals and public health is used efficiently.
Detailed description
RATIONALE In the first part, the population will be composed of healthy children, in the second part, the investigators will include children with neuromuscular diseases. The two parts will follow the same process. The hypothesis is that the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the MI-E compared to guidance alone. The MI-E technique does not represent any documented risk in its use nor in its indication if the contraindications are respected (non-drained pneumothorax, hemoptysis and hemodynamic instability). Coaching modules (playful visual stimulation) have recently become available on MI-E devices. This experiment will allow us to judge their usefulness in teaching the use of MI-E in paediatric patients.
OBJECTIVES The aim of this study is to test whether the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the technique compared to guidance alone. This randomized controlled study will first include healthy children, aged 6 to 12 years. In a second phase, the investigators will test the use in children with neuromuscular diseases. For the process (common for the two parts), eligible subjects will be invited to perform, depending on randomization at the intervention 1 (physiotherapist guidance + coaching module) or the intervention 2 (physiotherapist guidance). The learning times, the coughing expiratory flow rate achieved and the synchronization between the subject and the machine will be compared between the two processes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Only physiotherapist guidance | Active comparator | Other: Learning the use of an in-exsufflation device with the guidance of a physiotherapistThe aim of this study is to test whether the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the technique compared to guidance alone. |
| Physiotherapist guidance + coaching module | Active comparator | Other: Learning the use of an in-exsufflation device with the guidance of a physiotherapist, Other: Using the coaching modeThe aim of this study is to test whether the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the technique compared to guidance alone. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| Learning the use of an in-exsufflation device with the guidance of a physiotherapistLearning to use an in-exsufflation device with the guidance of a physiotherapist | Other | Only physiotherapist guidance, Physiotherapist guidance + coaching module |
| Using the coaching modeLearning the use of an in-exsufflation device using a coaching mode (playful visual stimulation) in addition to guidance of a physiotherapist | Other | Physiotherapist guidance + coaching module |
Primary outcome
Effectiveness
Time frame: A the end of the learning session (after maximum 15 minutes)
The investigators will measure the number of sets (n) needed by the subjects to achieve five quality voluntary coughs during the learning session.
Effectiveness
Time frame: A the end of the learning (after maximum 15 minutes).
The investigators will measure the time needed (sec) by the subjects to achieve five quality voluntary coughs during the learning session.
8 secondary outcomes
Peak cough flow measured with the device (L/min)
Time frame: During the learning session (max 15 minutes)
Peak cough flow measured with the device (L/min)
Time frame: During the session on the second day (24 hours after the learning session)
Visual analog scales (VAS) "ease of use" (0-10)
Time frame: At the end of the learning session (max 15 minutes)
Visual analog scales (VAS) "ease of use" (0-10)
Time frame: At the end of the session on the second day (24 hours after the learning session)
Visual analog scales (VAS) "comfort" (0-10)
Time frame: At the end of the learning session (max 15 minutes)
Visual analog scales (VAS) "comfort" (0-10)
Time frame: At the end of the session on the second day (24 hours after the learning session)
the number of sets (n)
Time frame: At the end of the session on the second day (24 hours after the learning session)
the time (sec) needed by the subjects to achieve five Quality voluntary coughs
Time frame: At the end of the session on the second day (24 hours after the learning session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 28546380Panitch HB. Respiratory Implications of Pediatric Neuromuscular Disease. Respir Care. 2017 Jun;62(6):826-848. doi: 10.4187/respcare.05250.
- Background: PubMed 22949331Miske LJ, McDonough JM, Weiner DJ, Panitch HB. Changes in gastric pressure and volume during mechanical in-exsufflation. Pediatr Pulmonol. 2013 Aug;48(8):824-9. doi: 10.1002/ppul.22671. Epub 2012 Sep 4.
- Background: PubMed 36787316Hov B, Andersen T, Toussaint M, Mikalsen IB, Vollsaeter M, Markussen H, Indrekvam S, Hovland V. User-perceived impact of long-term mechanical assisted cough in paediatric neurodisability. Dev Med Child Neurol. 2023 May;65(5):655-663. doi: 10.1111/dmcn.15543. Epub 2023 Feb 14.
- Background: PubMed 22730428Hull J, Aniapravan R, Chan E, Chatwin M, Forton J, Gallagher J, Gibson N, Gordon J, Hughes I, McCulloch R, Russell RR, Simonds A. British Thoracic Society guideline for respiratory management of children with neuromuscular weakness. Thorax. 2012 Jul;67 Suppl 1:i1-40. doi: 10.1136/thoraxjnl-2012-201964. No abstract available.
- Background: PubMed 33393110Hov B, Andersen T, Toussaint M, Vollsaeter M, Mikalsen IB, Indrekvam S, Hovland V. Prevalence of long-term mechanical insufflation-exsufflation in children with neurological conditions: a population-based study. Dev Med Child Neurol. 2021 May;63(5):537-544. doi: 10.1111/dmcn.14797. Epub 2021 Jan 3.
- Individual participant dataSharing planned: No
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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.
Nicolas Audag, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning the use of an in-exsufflation device with the guidance of a physiotherapist and Using the coaching mode in people with Cough and Airway Clearance Impairment, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 11 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Jun 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Audag, PhD (027641621, nicolas.audag@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: A the end of the learning session (after maximum 15 minutes)). The study lists 2 primary outcomes in all. 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 NCT06190431, which also lists 5 linked publications.
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 1 Jun 2026.