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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT04599803
Eligibility Criteria:
Inclusion Criteria:
* Ages 18 or older
* Able to speak and read English
* Legal United States Resident with a Government Issued ID
* Participating in the Project Baseline Community Study
* Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form
* Own a smartphone with a data plan and be the primary user of the smartphone; smartphone must use Android Lollipop (5.1+/ API 22+) or iOS 11.X+
* Own a computer with a web camera
* Consistent access to electricity and wifi for the duration of the study
* Have a high risk of OSA as determined by screening questionnaire
* Good candidate for PAP therapy, in the opinion of the managing clinician
* Without significant limitation in ability to participate in the study, in the opinion of the investigator.
Exclusion Criteria:
* Previously diagnosed with sleep apnea or other sleep disorders, that in the opinion of the investigator, makes the participant ineligible (e.g., Obstructive Sleep Apnea, Central Sleep Apnea, Complex Sleep Apnea, chronic insomnia)
* Participant is a shift worker (indicated by having a night shift schedule on a regular basis, or a work shift that changes or rotates on a daily, weekly, or monthly basis)
* Sponsor employees and individuals working on Project Baseline
* Self reported to be pregnant or planning to become pregnant during the study period
* Current use of home oxygenation devices, such as supplemental oxygen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04599803
Study Brief:
Protocol Section:
NCT04599803