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:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT02484300
Eligibility Criteria:
Inclusion Criteria:
* Male
* Ages 18-70 years
* No other sleep disorders
* Severe OSA (≥30 apnea hypopnea index)
Exclusion Criteria:
* Females
* Smokers (quit ≥ 1 year ago acceptable)
* Abnormal lung function (FEV1 and FVC \< 80% predicted)
* Any known cardiac (apart from treated hypertension with acceptable drugs, see below), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, hepatic disease, or patients with diabetes.
* History of driving or other accidents due to sleepiness or an ESS \> 18.
* Prior or current use of melatonin.
* Use of serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, ACE inhibitors or any drugs which interfere with the renin-Angiotensin system, Losartan (or other Angiotensin II type 1 receptor antagonists), non-specific calcium channel blockers (L channel specific are acceptable), anti-inflammatories, vitamins or any antioxidants.
* Use of any medications that may affect sleep or breathing.
* A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
* Substantial alcohol (\>3oz/day) or use of illicit drugs.
* More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02484300
Study Brief:
Protocol Section:
NCT02484300