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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT02753959
Eligibility Criteria:
Inclusion Criteria: STABLE
* Neuromuscular disease e.g. muscular dystrophy, motor neurons disease
* Respiratory muscle weakness (FVC \<60%, snip \<60%, sleep disordered breathing)
* Clinical evidence of respiratory secretions or cough PEF \<270 and history of LRTI
* Documented clinical stability by supervising clinician
Inclusion Criteria: ACUTE
* Neuromuscular disease e.g. muscular dystrophy, motor neurons disease
* Respiratory muscle weakness (FVC \<60%, snip \<60%, sleep disordered breathing)
* Clinical evidence of respiratory secretions or cough PEF \<270
* Admitted with respiratory deterioration
Exclusion Criteria: STABLE
* Decompensated respiratory failure (pH \< 7.35)
* Pregnancy
* Aged \<18, \>80
* Change in ventilator settings in preceding 4 weeks
* Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
Exclusion Criteria: ACUTE
* Decompensated respiratory failure (pH \< 7.35), at time of recruitment
* Pregnancy
* Aged \<18, \>80
* Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02753959
Study Brief:
Protocol Section:
NCT02753959