Breathing Support Device Tested in Amyotrophic Lateral Sclerosis
Tests a cough-assist breathing device in adults with amyotrophic lateral sclerosis.
Key facts
- Who runs it
- University Hospital, Toulouse
- Where
- Toulouse, FranceSee the site
- Trial code
- Registry title
- Breathing With Amyotrophic Lateral Sclerosis
- Status
- Recruiting
- People taking part
- 36 people, planned
- Started
- 29 Aug 2023
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Treatments tested
- Mechanical In-Exsufflator treatment
- Record updated
- 12 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with confirmed probable or certain ALS. It tests a cough-assist device (mechanical in-exsufflator) on their breathing and cough strength.
- Age
- 18 Years to 100 Years
- Sex
- All sexes can join.
- Disease stage
- Probable or certain ALS (Awaji-Shima criteria), spinal, bulbar or respiratory form. Peak cough flow between 160 and 255 L/min.
- Earlier treatment
- No treatment with the mechanical in-exsufflator in the past year (less than 10 sessions in total). Must have physiotherapy at least twice a week.
Main reasons for not taking part
- Psychiatric or cognitive disorders that make taking part impossible
- A reason the device cannot be used (for example pneumothorax)
- Not enough French to understand the study and fill in the questionnaires
- Current or past participation in another research or care program on breathing
- An emergency where the device is needed within less than a week
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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 take part
- 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; Exclusion during the study :
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Where in France
- SLA Center - Purpan University Hospital Toulouse, FRANCEToulouse, FranceContact: Floriane LLORENSTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Mechanical In-Exsufflator treatmentTreatment being tested
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Breathing Support Device Tested in Amyotrophic Lateral SclerosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05819931, who can take part
- Record updated
- 12 May 2026