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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT07071935
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with ALS using the Gold Coast Criteria within the last 6 months
* Age ≥18 years
* Willingness and ability to participate in study procedures
* Provision of signed and dated informed consent form
Exclusion Criteria:
1. Current or prior or recommended/prescribed use of NIV including:
i) bi-level positive pressure ventilation, such as a respiratory assist device or home ventilator ii) Current or prior use of continuous positive airway pressure, or "CPAP" therapy
2. Forced vital capacity \<50% of predicted normal
3. Maximal inspiratory pressure \> -60 cmH2O (eg, -50 or -40 cmH2O would be excluded)
4. Chronic use of supplemental oxygen at any part of the day
5. Enrollment in hospice
6. Current tracheostomy
7. Prior history of sleep apnea where non-invasive ventilation was used or recommended
8. Thoracic, abdominal, facial or ophthalmic surgery in the prior 6 weeks
9. Coughing up blood
10. Myocardial infarction in the previous 4 weeks
11. Absolute contraindication to NIV, which includes lethargy, obtundation, facial fractures, active pneumothorax, and airway obstruction (such as a tumor)
12. Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07071935
Study Brief:
Protocol Section:
NCT07071935