Breathing With Amyotrophic Lateral Sclerosis
Recruiting now · Not applicable
Conditions studied: Amyotrophic Lateral Sclerosis
In brief
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.
Key facts
- Study ID
- NCT05819931
- Run by
- University Hospital, Toulouse
- People needed
- 36
- Starts
- 2023-08-29
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-05-12
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- SLA Center - Purpan University Hospital Toulouse, FRANCE — Toulouse, Occitanie, France (enrolling)
Full record on ClinicalTrials.gov
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