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 @ 11:11 PM
Ignite Modification Date:
2025-12-24 @ 11:11 PM
NCT ID:
NCT04572269
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 30-75 years old
4. In good general health as evidenced by medical history and diagnosed with Obstructive Sleep Apnea (defined as AHI\>5)
5. Ability to use accelerometer, perform Type 2 sleep test at home and agree to use PAP treatment.
6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
Exclusion Criteria:
1. Current use of PAP treatment or mandibular advancement device or INSPIRE device
2. Presence of active cancer treatment or heart failure (ejection fraction \<40%)
3. Pregnancy or lactation
4. Known allergic reactions to components of the plastic (used in PAP mask)
5. Febrile illness within 2 weeks of signing consent
6. Current drug or alcohol abuse
7. Known diagnosis and treatment of diabetes because this will independently alter metabolomic results.
8. Previously drawn laboratory Hemoglobin A1C above normal range (indicative of diabetes).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT04572269
Study Brief:
Protocol Section:
NCT04572269