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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT02314858
Eligibility Criteria:
Inclusion Criteria:
* Polysomnography (PSG) confirmed diagnosis of Obstructive Sleep Apnea (OSA)
* choice of PAP as preferred treatment
* judged by sleep physicians to be responders to PAP
* participants will be considered responders to PAP if they have an AHI of less than 5, do not snore, and have an arousal index of less than 10 when titrated to the proper pressure of PAP
Exclusion Criteria:
* Apnea-Hypopnea Index (AHI) \< 15 on the diagnostic PSG and no daytime functional symptoms or associated cardiovascular disease
* a sleep disorder other than OSA that causes arousals from sleep (e.g., periodic limb movements, restless legs syndrome, insomnia)
* a current substance abuse problem
* a serious sleep-disruptive medical condition (e.g., end stage renal failure, severe Chronic Obstructive Pulmonary Disease (COPD), severe asthma)
* significant global cognitive impairment
* history of or current diagnosis of psychosis, bipolar disorder, or borderline, schizotypal or antisocial personality disorder, and uncontrolled depression or suicidal ideation
* change in antidepressant medications over the past 3 months
* women pregnant women, breast feeding, or planning on becoming pregnant
* currently enrolled in another research study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT02314858
Study Brief:
Protocol Section:
NCT02314858