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 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT01312168
Eligibility Criteria:
OSA patients
Inclusion Criteria:
* male patients aged 30 to 65 year who have daytime sleepiness (ESS\>=10)
* newly diagnosed OSA (AHI\>30/hr) by overnight PSG but never been treated
Exclusion Criteria:
* unwilling or unable to perform testing procedure
* past or current smoking history
* medical condition (including cardiovascular disease, chronic pulmonary disease, diabetes, endocrinologic disease, chronic renal failure, and psychiatric disease)
* systemic inflammatory conditions (system lupus erythematosus, rheumatoid arthritis, sarcoidosis, Crohn's disease, and ulcerative colitis)
* active neurologic event
* active infection two weeks prior to screening
* enrolled in other trials in the study period
* other sleep disorders
* sleepy driver
* using maintenance medications
Control subjects
Inclusion Criteria:
* Age-, sex-, body weight-, height-matched subjects with enrolled OSA patients
* non-sleepy
* no OSA confirmed by home sleep study (AHI\<5/hr)
Exclusion Criteria:
* unwilling or unable to perform testing procedure
* past or current smoking history
* medical condition (including cardiovascular disease, chronic pulmonary disease, diabetes, endocrinologic disease, chronic renal failure, and psychiatric disease)
* systemic inflammatory conditions (system lupus erythematosus, rheumatoid arthritis, sarcoidosis, Crohn's disease, and ulcerative colitis)
* active neurologic event
* active infection two weeks prior to screening
* enrolled in other trials in the study period
* other sleep disorders
* using maintenance medications
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT01312168
Study Brief:
Protocol Section:
NCT01312168