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:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
NCT ID:
NCT03506906
Eligibility Criteria:
Inclusion Criteria:
* Patients with chronic hypercapnic respiratory failure secondary to one or more identified condition(s) (chronic obstructive pulmonary disease, obesity hypoventilation syndrome, neuromuscular diseases, restrictive lung diseases)
* Home mechanical ventilation for ≥ 6 months
* Stable condition for ≥ 1 month
Exclusion Criteria:
* Previous adjustment of the noninvasive ventilation therapy under sleep studies in the last 6 months
* Current respiratory exacerbation
* Any current comorbidity decompensation
* Any medical or psychological condition impairing the patient's ability to provide informed consent
* Missing signed informed consent
* Total sleep time during polysomnography \<180 min
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03506906
Study Brief:
Protocol Section:
NCT03506906