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 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT05328492
Eligibility Criteria:
Inclusion Criteria:
Patients with respiratory failure secondary to ALS (diagnosed either at an MND MDT or specialist neurology clinic) according to criteria set out in the NICE guideline (NG42) (2016); Motor neurone disease: assessment and management.
* Patients able to provide informed consent to take part in the research study.
* Patients not contraindicated to commence NIV in accordance with local protocol.
* Patients not currently enrolled in another research study that could alter disease progression.
Exclusion Criteria:
* Acutely unwell or medically complicated patients as assessed by lead investigator. These patients will be urgently reviewed by a dedicated Consultant Physician. The Principal Investigator will be immediately informed.
* An inability to provide informed consent.
* An inability to use NIV.
* Patients whom are contraindicated to commence NIV in accordance with local protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05328492
Study Brief:
Protocol Section:
NCT05328492