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:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT04224961
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Confirmed diagnosis of ALS
* Ability to follow directions for study participation
* Ability to successfully and independently complete RMT repetitions at a minimum pressure-threshold target equal to 30% of MIP or MEP
* Ability to complete telehealth visits using a smartphone or computer with video capabilities
* Ability to complete a home-RMT regimen
Exclusion Criteria:
* MIP \< 40 cmH20
* Presence of a tracheostomy
* Use of non-invasive or invasive ventilation when awake
* Participant or caregiver(s) inability to manipulate respiratory pressure meter, the RMT device, or calibration equipment for home training
* Inability to complete RMT repetitions successfully
* Concomitant neurologic or neurodegenerative conditions (e.g. stroke, dementia) or other serious conditions that would prevent meaningful study participation as determined at the discretion of the principal investigator
* Inability to give legally effective consent
* Inability to read and understand English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04224961
Study Brief:
Protocol Section:
NCT04224961