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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT03552133
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75 years old, inclusive
2. Moderate to severe OSA (Apnea hypopnea index \[AHI\] \>15 events/hr of sleep)
3. Newly diagnosed OSA, or have either refused to or have not tolerated PAP treatment, or are currently using Positive Airway Pressure (PAP) and are willing to hold it during the night of sleep study visits.
4. Willing and able to provide consent to 5 laboratory visits with 4 full nights of sleep study.
5. Self report of still having sleep apnea since the last sleep test (if diagnosis was greater than a year prior).
Exclusion Criteria:
1. BMI \>45 kg/m2
2. AHI\<15 events/hour on the first night of sleep testing in our research laboratory (Visit 2)
3. Cigarette smoking of 1 pack per day or more within 6 months of screening;
4. Diagnosed heart failure or coronary artery disease.
5. Diagnosed cerebrovascular disease, Transient Ischemic Attack (TIA) or stroke.
6. Diagnosed asthma or chronic obstructive pulmonary disease with significant airways obstruction (FEVI/Forced Vital Capacity \<65%)
7. End-stage hepatic or renal disease
8. Significant daytime sleepiness in subjects who have risky occupations or life-style (for example, working in the transportation industry, history of motor vehicle crash, occupation that requires vigilance for safety or performance)
9. Pregnancy (assessed on urine test at V1 in females with childbearing potential)
10. Clinically significant arrhythmia/dysrhythmias on the clinical diagnostic polysomnography (per medical record) or on research polysomnography conducted at V2
11. Established diagnosis of neuromuscular disease (e.g., Parkinsonism, multiple sclerosis, syringomyelia, transverse myelitis, amyotrophic lateral sclerosis, poliomyelitis, Eaton-Lambert, Guillain-Barre, myasthenia gravis, myotonic dystrophy, mononeuritis multiplex, in the setting of polymyositis/dermatomyositis or severe cervical spine disease)
12. Any current use of benzodiazepines, opioids, or barbiturates
13. Any medical or psychiatric condition which in the opinion of the medical director interferes with the subject's ability to enroll or to continue in the study (once enrolled)
14. Veteran, cared for in the VA system
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03552133
Study Brief:
Protocol Section:
NCT03552133