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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT04211350
Eligibility Criteria:
Inclusion Criteria:
1. Subject is adult
2. Either: Treatment naïve, or PAP non-complier (defined as current AAP user with \<3 hours per night in the last 3 months per compliance download), and willing to use the APAP device per protocol
3. Diagnosis of POSA meeting all the following criteria per control PSG within 6 months of screening: AHI of \>15 during PSG with symptoms of sleepiness per Investigator discretion, or AHI of \>15 during respiratory polygraphy with comorbidities (e.g. atrial fibrillation, resistant hypertension, etc.)
4. Supine AHI at least twice the lateral AHI
5. Lateral AHI \<10
6. Supine time \>30% and \<70%
7. Understands the study protocol and is willing and able to comply with study requirements and sign informed consent. APAP non-compliant subjects must be willing to use their APAP device per protocol.
Exclusion Criteria:
1. Prior or current therapy or treatment for OSA (for Treatment naïve group); Greater than an average of 3 hours per night of APAP use (in the APAP non-complier group)
2. A female of child-bearing potential that is pregnant or intends to become pregnant
3. Any unstable or severe medical condition of any organ system that at the discretion of the site Principal Investigator (PI) might affect the patient's participation in the study or generalization of treatment results
4. Taking medication that at the discretion of the site Principal Investigator (PI) might affect the patient's participation in the study or generalization of treatment results
5. Oxygen use
6. The presence of any other sleep disorder (central sleep apnea (CSA \>5), periodic limb movement disorder (PLMAI \>15), clinical diagnosis of insomnia or narcolepsy)
7. Excessive alcohol consumption (\>21 drinks/week)
8. The use of any illegal drug(s), per subject report
9. Night or rotating shift work
10. Severe claustrophobia
11. Shoulder, neck, or back complaints that restrict sleeping position
12. Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04211350
Study Brief:
Protocol Section:
NCT04211350