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New treatment option for Amyotrophic Lateral Sclerosis ALS7
Official title The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in ALS Patients
ClinicalTrials.gov ID: NCT06249412
What this study is testing
- What it's testing
- Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disorder that impairs motor neurons, with a life expectancy of 2 to 7 years after diagnosis. ALS manifests as 'spinal' when it primarily affects limbs, or 'bulbar' when it impairs speech and swallowing.
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
- Male or female patient aged over 18 years
- Patient with Amyotrophic Lateral Sclerosis (ALS)
- Patients with established or beginning bulbar disorders, identified by the healthcare team (speech impairment, hypersalivation, or swallowing...
- Patient naive to INEX therapy but prescribed for its installation or patient already treated by an INEX device
- Patient followed by the ALS mobile team of the Groupe Hospitalier du Havre or the CHU of Dijon
You likely can't join if
- "● Patient not presenting an episode of infection or a past episode of respiratory infection less than one month old
- Mental illness interfering with the proper use of the device
- History of laryngospasm
- Inability to come for consultation with the ALS team of the Groupe Hospitalier du Havre or the CHU of Dijon
- Pregnancy
- Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or...
See the full eligibility criteria
- Male or female patient aged over 18 years
- Patient with Amyotrophic Lateral Sclerosis (ALS)
- Patients with established or beginning bulbar disorders, identified by the healthcare team (speech impairment, hypersalivation, or swallowing difficulties)
- Patient naive to INEX therapy but prescribed for its installation or patient already treated by an INEX device
- Patient followed by the ALS mobile team of the Groupe Hospitalier du Havre or the CHU of Dijon
- Patient whose disease progression kinetics is medically deemed compatible with inclusion in the study
- Patient willing to participate in the research after receiving adequate information and the information letter.
- Patient affiliated with social security or a beneficiary of such a scheme.
- "● Patient not presenting an episode of infection or a past episode of respiratory infection less than one month old
- Mental illness interfering with the proper use of the device
- History of laryngospasm
- Inability to come for consultation with the ALS team of the Groupe Hospitalier du Havre or the CHU of Dijon
- Pregnancy
- Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curatorship) Article L1121-8.
- Appearance of a non-inclusion criterion
- Refusal to participate after inclusion
- Death from any cause"
The study team makes the final eligibility decision.
Where it's taking place
- Le Havre, Normandy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Le Havre, Normandy, 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.