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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT02535234
Eligibility Criteria:
Inclusion Criteria
* Participant is willing to provide written informed consent
* Participant is able to read and comprehend written and spoken English
* Participant is ≥ 18 years of age
* Participant has been diagnosed with Obstructive Sleep Apnoea (OSA)
* Participants has been established on Continuous Positive Airway Pressure (CPAP) for ≥ 6 months
* Participants is currently using the same mask type/variant as the interventional mask system to be evaluated
* Participants is able to participate for the duration of the study
Exclusion Criteria
* Participant is not willing to provide written informed consent
* Participant is unable to read and comprehend written and spoken English
* Participant is \< 18 years of age
* Participant has not been diagnosed with Obstructive Sleep Apnoea (OSA)
* Participant has not been established on Continuous Positive Airway Pressure (CPAP) for ≥ 6 months
* Participant is not currently using the same mask type/variant as the interventional mask system to be evaluated
* Participant is unable to participate for the duration of the study
* Participant is pregnant
* Participant is established on bi-level support therapy
* Participant, or participants bed partner, has metallic implants in head neck or chest
* Participant has a with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. Chronic Obstructive Pulmonary Disease (COPD), lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection, lung injury)
* Participant is unsuitable to participate in the study in the opinion of the researcher
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02535234
Study Brief:
Protocol Section:
NCT02535234