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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT06393504
Eligibility Criteria:
1. Evidence of a singleton end of pregnancy event during the intake period.
2. ≥ 1 insomnia diagnosis during the period which begins 12 months prior to the date of conception and ends at the end of pregnancy.
3. Continuous medical and pharmacy insurance coverage during the period which begins 6 months prior to the date of conception and ends at the date of conception plus 40 weeks (equivalent to 42 gestational weeks).
4. Age 15 to 50 years at the date of conception.
5. No dispensing of known or suspected teratogenic medications during the period which begins 5 half lives of that medication prior to the date of conception and ends at the end of pregnancy.
6. No exposure to other orexin receptor antagonists during the exposure period, i.e., suvorexant, lemborexant, and any orexin receptor antagonists newly approved during the intake period.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
50 Years
Study:
NCT06393504
Study Brief:
Protocol Section:
NCT06393504