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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT02564068
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria:
* Men or women 18 years old or older of any ethnic background
* Subjects that have recently undergone a standard "in the sleep-lab" diagnostic polysonmography (per standard of care medical guidelines), or the "at home" diagnostic test for cohort B, and have been diagnosed with OSA will be recruited into a follow-up study to assess the beneficial effects of oxytocin treatment.
Exclusion Criteria:
* Pregnant or nursing women or women at any child bearing age who are not willing to undergo . methods to prevent pregnancy
* A female subject of childbearing potential is a nonmenopausal female who has not had a . hysterectomy, bilateral oopherectomy, or medically documented ovarian failure. Menopause . can be assumed to have occurred in a woman when there is either:
1. Appropriate medical documentation of prior complete bilateral oophorectomy OR
2. Permanent cessation of previously occurring menses as a result of ovarian failure with . documentation of hormonal deficiency. Ovarian hormonal deficiency is documented by . serum follicle stimulating hormone (FSH) level elevated to within the post-menopausal . . range based on the laboratory reference range where the hormonal assay is performed.
3. Menopause is defined as occurring 12 months after your last menstrual period and marks the . end of menstrual cycles
* Subjects who are on medications that affect cardiac autonomic function (eg. Beta blockers)
* Smokers
* Subjects who are unable to read or answer questions in the English language
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02564068
Study Brief:
Protocol Section:
NCT02564068