Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT06249412
Eligibility Criteria:
Inclusion 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.
Exclusion Criteria:
"● 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"
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06249412
Study Brief:
Protocol Section:
NCT06249412