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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT03176732
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 75 years
* Apnea-Hypopnea Index (AHI) ≥ 15 events/hr on diagnostic polysomnography(PSG)
* No previous history of surgical treatment of OSA, and no medical treatment of OSA within the past 6 months
* Adherence to prescribed anti-hypertensive medications as assessed by an average adherence between Visits 1-2 of at least 0.85
* Arm circumference less than 50 cm
Exclusion Criteria:
* Unable or unwilling to provide informed consent
* No telephone access or inability to return for follow-up
* Diagnosis of another sleep disorder in addition to OSA (e.g., periodic limb movement disorder \[greater than 5 limb movements associated with arousal/hr of sleep\], central sleep apnea \[greater than 50% of apneas are central apneas\], obesity hypoventilation syndrome, narcolepsy)
* Positive urine drug screen for any of the following: amphetamines, cocaine, opiates, barbiturates, benzodiazepines, phencyclidine (PCP), alcohol (ETOH), methadone (Visit 1)
* Requiring oxygen, bi-level positive airway pressure, or adaptive servo-ventilation for treatment of OSA
* Oxygen saturation \< 87% for a period of 2 minutes during resting wakefulness during home sleep testing (HST) or PSG (Visit 2)
* Severe and inadequately controlled arterial hypertension (SBP greater than 180 mm Hg; diastolic BP greater than 110 mm Hg on 2 of 3 spot measurements on Visit 1)
* Participants with 24-hr SBP ≥ 140 mm Hg who are not on BP medications and participants on 4 or more BP medications with a 24-hr SBP \< 135 mm Hg (Visit 2)
* A clinically unstable medical condition as defined by a change in medications in the previous month, including anti-hypertensive medications, or a new medical diagnosis in the previous 2 months (e.g., myocardial infarction, chronic heart failure, unstable angina, active infection, thyroid disease, depression or psychosis, cirrhosis, surgery, or cancer)
* Shift workers, individuals who regularly experience jet lag, or have irregular work schedules by history over the last 3 months
* Women who are pregnant or sexually active and of child-bearing age not using a form of contraceptive
* Routine consumption of \> 2 alcoholic beverages/day Excessive use of caffeine (greater than 10 cups/day)
* Inability to communicate verbally or less than a 5th grade reading level
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03176732
Study Brief:
Protocol Section:
NCT03176732