Amyotrophic Lateral Sclerosis2SLANCT05819931
Breathing With Amyotrophic Lateral Sclerosis
A study testing Mechanical In-Exsufflator treatment in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The study aims to evaluate the effect of mechanical insufflator-exsufflator on the respiratory functions of Amyotrophic Lateral Sclerosis (ALS) patients evaluated via peak expiratory flow on cough (PEFC) measurements. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Mechanical In-Exsufflator treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2023to 31 Dec 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed ALS categorized as probable or certain according to the revised Awaji-Shima criteria [27].
- ALS of spinal, bulbar or respiratory forms
- Peak Flow measure between 160 and 255 L/min (recommendation of MIE in case of congestion, with the possibility of daily sessions)
- Patient who has not benefited from treatment by MIE in the past year (less than 10 sessions in total)
- Patient able to use the MIE and perform the collection, or having a caregiver able to help
- Patient receiving physiotherapist treatment greater than or equal to twice a week
Who cannot join
- Psychiatric (DSM-5) or cognitive disorders incompatible with participation in the study
- Contraindication to the use of an MIE (pneumothorax for example)
- Insufficient level in French for understanding the study and completing the questionnaires
- Current or past participation in another innovative research or care program relating to respiratory functions
- Emergency situation for which the MIE must be set up within less than a week
- Appearance of a serious contraindication to the practice of MIE during the study (for example rib fracture during a fall)
- Patient's physiotherapist refusing to do the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Floriane LLORENS contact
France1 site, 1 recruiting
- Recruiting
SLA Center - Purpan University Hospital Toulouse, FRANCE
Toulouse, Occitanie, 31000
Floriane LLORENS, llorens.fl@chu-toulouse.fr
About this study
Official title: Evaluation of the Effect of Respiratory Physiotherapy by Mechanical In-exsufflator on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis: A Pilot Study
The study aims to evaluate the effect of mechanical insufflator-exsufflator on the respiratory functions of Amyotrophic Lateral Sclerosis (ALS) patients evaluated via peak expiratory flow on cough (PEFC) measurements. The evolution of their PEFC is monitored to see if the curative management can have a positive impact on the latter.
Read the detailed description
Amyotrophic Lateral Sclerosis (ALS) is a rare neurodegenerative pathology without curative treatment at present, the outcome is fatal after 3 to 5 years of evolution on average. The disease results in progressive paralysis of the muscles involved in voluntary motricity (progressive and intricate impairment of locomotor, phonation and swallowing capacities as well as ventilatory function). In France, the management of ALS is based on a diversified multidisciplinary follow-up (physiotherapy, speech therapy, occupational therapy, neuropsychology) in the ALS Reference Center in conjunction with the city care networks. It is centered on the evaluation, and the early compensation of the various symptoms, especially the respiratory problems.
Thus, this study aims to evaluate the effect of mechanical insufflator-exsufflator on the respiratory functions of these patients, evaluated via cough peak expiratory flow measurements (CPEF).
The study is conducted in collaboration with the physiotherapists of each patient enrolled, to evaluate the respiratory function by peak expiratory flow on cough (PEFC) after 4 weeks of treatment with Mechanical In-Exsufflator (MIE) (3 weekly sessions for two weeks, then one daily session for 2 weeks) in ALS patients presenting with a poorly effective cough (PEFC between 160 and 255 L/min) and having an indication of punctual MIE.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Mechanical In-Exsufflator treatment
- Keywords
- Mechanical In-Exsufflator, Physiotherapy, Cough, peak expiratory flow on cough
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical In-Exsufflator treatmentDevice
The Mechanical In-Exsufflator (MIE) is a device that alternately inhales and exhales air and amplifies the respiratory cycles in flow and pressure. 15 breathing cycles (about 3 minutes) are recommended each day.
Patients will practice the MIE daily independently and/or carried out by his physiotherapist (PT) during PT sessions.
The MIE is prescribed by the neurologist or pulmonologist and is covered by social security in France. It is gifted by an external service provider.
The Peak-Flow Cough is considered as the standardized score retaining the best of 3 consecutive measurements by Peak-Flow, a small portable device for personal use, which measures the maximum expiratory flow reached by the patient at the moment when the breath is most powerful.
The patient is his own control. At baseline, the patient will be treated as usual. He will be asked to read the Peak-Flow Cough measures. The PT will also perform the Peak flow measurement at each patient visit.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical In-Exsufflator treatment | Experimental | Not described Receives: Device: Mechanical In-Exsufflator treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
cough peak expiratory flow evolution
evolution of respiratory function by peak expiratory flow on cough (PEFC) after 4 weeks of treatment with Mechanical In-Exsufflator (3 weekly sessions for two weeks then one daily session for 2 weeks) in ALS patients presenting with a poorly effective cough (Cough Peak Expiratory Flow between 160 and 255) and having an indication of punctual MIE.
Ratio between the PEFC 4 weeks post treatment initiation and PEFC at baseline can show decrease in respiratory function if <1 ; increase in respiratory functions if >1 and a conservation of respiratory function if = 1.
A PEFC remaining within 10% of its initial value (rounded to the nearest ten) is considered unmodified
Measured: 4 weeks post treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start29 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- before-after comparison of the treatment
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Lagarde, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819931
- Sponsor's protocol ID
- RC31/22/0411
- Acronym
- 2SLA
- Status last verified
- May 2026
- First submitted
- 6 Apr 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Respiratory Physiotherapy by Mechanical In-exsufflator on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT05819931
- Acronym / sponsor ID
- 2SLA / RC31/22/0411
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Mechanical In-Exsufflator, Physiotherapy, Cough, peak expiratory flow on cough
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Apr 2023 (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 study aims to evaluate the effect of mechanical insufflator-exsufflator on the respiratory functions of Amyotrophic Lateral Sclerosis (ALS) patients evaluated via peak expiratory flow on cough (PEFC) measurements. The evolution of their PEFC is monitored to see if the curative management can have a positive impact on the latter.
Detailed description
Amyotrophic Lateral Sclerosis (ALS) is a rare neurodegenerative pathology without curative treatment at present, the outcome is fatal after 3 to 5 years of evolution on average. The disease results in progressive paralysis of the muscles involved in voluntary motricity (progressive and intricate impairment of locomotor, phonation and swallowing capacities as well as ventilatory function). In France, the management of ALS is based on a diversified multidisciplinary follow-up (physiotherapy, speech therapy, occupational therapy, neuropsychology) in the ALS Reference Center in conjunction with the city care networks. It is centered on the evaluation, and the early compensation of the various symptoms, especially the respiratory problems.
Thus, this study aims to evaluate the effect of mechanical insufflator-exsufflator on the respiratory functions of these patients, evaluated via cough peak expiratory flow measurements (CPEF).
The study is conducted in collaboration with the physiotherapists of each patient enrolled, to evaluate the respiratory function by peak expiratory flow on cough (PEFC) after 4 weeks of treatment with Mechanical In-Exsufflator (MIE) (3 weekly sessions for two weeks, then one daily session for 2 weeks) in ALS patients presenting with a poorly effective cough (PEFC between 160 and 255 L/min) and having an indication of punctual MIE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before-after comparison of the treatment
| Arm | Type | Receives |
|---|---|---|
| Mechanical In-Exsufflator treatment | Experimental | Device: Mechanical In-Exsufflator treatment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed ALS categorized as probable or certain according to the revised Awaji-Shima criteria [27].
- ALS of spinal, bulbar or respiratory forms
- Peak Flow measure between 160 and 255 L/min (recommendation of MIE in case of congestion, with the possibility of daily sessions)
- Patient who has not benefited from treatment by MIE in the past year (less than 10 sessions in total)
- Patient able to use the MIE and perform the collection, or having a caregiver able to help
Key exclusion criteria (7 listed)
- Psychiatric (DSM-5) or cognitive disorders incompatible with participation in the study
- Contraindication to the use of an MIE (pneumothorax for example)
- Insufficient level in French for understanding the study and completing the questionnaires
- Current or past participation in another innovative research or care program relating to respiratory functions
- Emergency situation for which the MIE must be set up within less than a week
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 |
|---|---|---|
| Mechanical In-Exsufflator treatmentThe Mechanical In-Exsufflator (MIE) is a device that alternately inhales and exhales air and amplifies the respiratory cycles in flow and pressure. 15 breathing cycles (about 3 minutes) are recommended each day. Patients will practice the MIE daily independently and/or carried out by his physiotherapist (PT) during PT sessions. The MIE is prescribed by the neurologist or pulmonologist and is covered by social security in France. It is gifted by an external service provider. The Peak-Flow Cough is considered as the standardized score retaining the best of 3 consecutive measurements by Peak-Flow, a small portable device for personal use, which measures the maximum expiratory flow reached by the patient at the moment when the breath is most powerful. The patient is his own control. At baseline, the patient will be treated as usual. He will be asked to read the Peak-Flow Cough measures. The PT will also perform the Peak flow measurement at each patient visit. | Device | Mechanical In-Exsufflator treatment |
Primary outcome
cough peak expiratory flow evolution
Time frame: 4 weeks post treatment initiation
evolution of respiratory function by peak expiratory flow on cough (PEFC) after 4 weeks of treatment with Mechanical In-Exsufflator (3 weekly sessions for two weeks then one daily session for 2 weeks) in ALS patients presenting with a poorly effective cough (Cough Peak Expiratory Flow between 160 and 255) and having an indication of punctual MIE. Ratio between the PEFC 4 weeks post treatment initiation and PEFC at baseline can show decrease in respiratory function if <1 ; increase in respiratory functions if >1 and a conservation of respiratory function if = 1. A PEFC remaining within 10% of its initial value (rounded to the nearest ten) is considered unmodified
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 12 May 2026.
Related trials for Amyotrophic Lateral Sclerosis
Not yet recruitingPhase 1
A Study of Single Ascending Doses of NI112 in Adults With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Recruiting
Anticipated Patient and Caregiver Burden
Amyotrophic Lateral Sclerosis
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
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.
Floriane LLORENS contact
Thierry Lagarde principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical In-Exsufflator treatment in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Toulouse 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 6 inclusion and 7 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 12 May 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 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?
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 Thierry LAGARDE, PT (+33561775570, lagarde.t@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cough peak expiratory flow evolution (time frame: 4 weeks post treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.