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New treatment option for Amyotrophic Lateral Sclerosis
Official title Breathing With Amyotrophic Lateral Sclerosis
ClinicalTrials.gov ID: NCT05819931
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join 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
You likely can't join 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)
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, Occitanie, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, Occitanie, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.