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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT06430333
Eligibility Criteria:
Inclusion Criteria:
1. Singleton pregnancy, gestational week 14-31 at screening.
2. DSM-5 Insomnia Disorder (≥1 month duration).
3. Insomnia Severity Index (ISI) score ≥ 11.
4. Edinburgh Postnatal Depression Scale score\<13 at screening.
5. No current DSM-5 Major Depression.
6. Reliable internet access for treatment and assessments.
7. Not currently engaged in therapy for major depression or insomnia disorder.
8. Age 18 years or older.
Exclusion Criteria:
1. High risk pregnancy (pre-eclampsia, placenta previa w/ hemorrhage, other conditions deemed serious risk to mother or fetus; hypertension and diabetes are allowed).
2. Active suicidal intent.
3. Night or rotating shift work, anticipated travel across time 3 or more time zones in the 2 months after baseline screening.
4. Untreated RLS (treated RLS is OK).
5. Excessive daytime sleepiness; Epworth Sleepiness Scale\>15.
6. Uncontrolled sleep or mental disorder inappropriate or unsafe for sleep restriction (narcolepsy, bipolar, epilepsy, etc.).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06430333
Study Brief:
Protocol Section:
NCT06430333