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 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT02590159
Eligibility Criteria:
Inclusion Criteria:
* Capacity and willingness to sign informed consent
* ≥ 21 years of age
* Diagnosis of mild to moderate OSA (AHI ≥ 5 and AHI \< 30) within 12 months of the screening visit.
* Able to tolerate using the device during a day time trial/acclimation
* Are currently using CPAP or have been prescribed CPAP and are considered CPAP non-adherent (as per either their CPAP data card and/or verbal confirmation of a diagnosis and unwillingness to use CPAP)
Exclusion Criteria:
* Nasal deformities
* Severe nasal allergies
* Rhinitis or moderate nasal congestion, acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
* Co-morbid sleep disorders
* Currently on a hypnotic for insomnia (who have had insomnia for more than a month and take a hypnotic on a daily basis and/or transient insomnia being treated)
* Uncontrolled or serious illness, including but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure.
* Full Face Mask user
* Mouth breather
* Pregnant (Female subjects of child bearing age will be asked if they are and/or planning on becoming pregnant during the study; acceptable methods of birth control include birth control pills and barrier method)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02590159
Study Brief:
Protocol Section:
NCT02590159