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 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT06906133
Eligibility Criteria:
Inclusion Criteria:
1. Women, 18-36 years
2. Body Mass Index (BMI) \<=35
3. Regular menstrual cycle, defined as: length of menstrual cycle 22-35 days and length of menses \<10 days.
4. Women with natural menstrual cycle (i.e., do not use any type of hormonal contraceptives) and women using contraceptives (comparison group).
Exclusion Criteria:
Previously diagnosed with:
1. Sleep apnea, clinical insomnia, restless leg syndrome, narcolepsy.
2. Shift work and trans-meridian travel during the study period.
3. Chronic atrial fibrillation or ventricular trigemini, severe uncontrolled asthma, or other pulmonary diseases.
4. Premenstrual Dysphoric Disorder (PMDD) or severe Premenstrual Syndrome (PMS).
5. Other severe medical conditions that may affect cerebral metabolism, cancer, diabetes, rheumatoid arthritis, or other chronic health conditions.
6. Severe psychiatric conditions, Major Depressive disorder, Generalized Anxiety Disorder, Bipolar Disorder, Personality Disorder, OCD, Schizophrenia.
7. Severe neurological conditions, epilepsy, traumatic brain injury, and previous neurosurgery.
8. Habitual smokers and other habitual substance abuse or dependence on substances.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
36 Years
Study:
NCT06906133
Study Brief:
Protocol Section:
NCT06906133