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:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT04926805
Eligibility Criteria:
Inclusion Criteria:
* Already using overnight CPAP and tolerating the therapy well (over 4 hours use/night)
* Hypercapnia: venous bicarbonate of 30 milliequivalents of solute per liter (Eq/L) or more, OR transcutaneous carbon dioxide (TcCO2) of 50 millimeters of mercury (mmHg) of more.
* Provide written informed consent
* Already use a full (oronasal) face mask for CPAP
* Willing to have a venous blood sample taken during the pre-screening visit.
Exclusion Criteria:
* Presence of sleep apnea on CPAP:
* Subjects excluded if they have an apnea-hypopnea index (AHI) of more than 20, or
* If the AHI has not already decreased by 50 percent or more from pre-CPAP to with CPAP.
* Forced expiratory volume in 1 second (FEV1) of less than 40 percent of predicted.
* Forced expiratory volume in 1 second divided by forced vital capacity (FEV1/FVC) less than fifty percent of predicted, at the screening visit.
* Have poorly controlled asthma or changing asthma symptoms.
* Nasal obstruction
* Do not fit Mask A or Mask B
* Agitation or psychological illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04926805
Study Brief:
Protocol Section:
NCT04926805