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 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT04615832
Eligibility Criteria:
Inclusion Criteria:
* Persons who are ≥ 22 years of age
* Persons who weigh ≥ 66 lbs (30 kgs)
* Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician
* Persons who are compliant with PAP therapy for ≥ 4 hours per night for 70% of nights for at least two weeks prior to enrolment in the trial
* Persons who are currently using a full face mask
* Persons who have an IPAP pressure of \< 30 cmH2O
* Persons who currently use a PAP therapy device with data recording capabilities
* Persons who are fluent in spoken and written English
* Persons who possess the capacity to provide informed consent
Exclusion Criteria:
* Persons who are intolerant to PAP therapy
* Persons who are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps
* Persons using nasal or nasal pillows masks
* Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
* Persons who are pregnant or think they may be pregnant
* Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2
* Persons who currently have cold or flu like symptoms at the time of recruitment
* Persons who have tested positive for COVID-19 within the previous 28 days prior to enrolment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT04615832
Study Brief:
Protocol Section:
NCT04615832