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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07391150
Eligibility Criteria:
Inclusion Criteria:
* Patients requiring NIV as part of usual clinical care at SCH
* Age 1 month to 16 years.
* Difficulties with current NIV interface
* Only patients that are using NIV for breathing support will be included, ie those with hypoventilation and obstructive sleep apnoea, where the ventilator supports the patient's own breathing.
Exclusion Criteria:
* Families who do not understand written or verbal English where no interpreter is available.
* Children who do not attend with their parent /legal guardian and so are therefore unable to give informed consent.
* Patients deemed too unwell, or unsuitable, by the clinical team
* Patients with adequately functioning NIV interface.
* Patients requiring supplementary medical gases, eg oxygen.
* Patients requiring NIV for rescue breaths will be excluded, ie those with disorders of respiratory control where the ventilator is delivering breaths where the patient has stopped breathing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
16 Years
Study:
NCT07391150
Study Brief:
Protocol Section:
NCT07391150