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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT05806450
Eligibility Criteria:
Inclusion Criteria:
* Child's primary nighttime caregiver (mothers or fathers) of full-term, healthy, singleton, 6 to 24 months old
* Caregiver participants aged between 19 to 65 years
* The caregiver who is a native speaker of Korean (a person who is able to listen, speak, and write in Korean, and does not have any difficulties in understanding the Korean language)
* Residents of South Korea
* Sleep arrangements without restriction for using an auto-videosomnography device: (1) parent-child sleep separately (one should not change the sleep arrangement only for the participation in the study); (2) if parents and child share a bed, the child's own space should be large enough for the videosomnography camera to capture child body solely.
* Be available on devices with the camera (e.g., tablets, personal computers) for the online intervention/session
Exclusion Criteria:
* Child's gestational age before 37 weeks or after 42 weeks
* Children with developmental disability
* Caregiver participant (or partner) who is currently working the night shift or night duty
* Caregiver participant who has a history of sleep disorders besides insomnia
* Caregiver participant who has lifetime bipolar disorder, schizophrenia spectrum, and other psychotic disorders, alcohol, caffeine, or other substance substance-related disorders, neurocognitive disorders, thyroid-related disorders, or epilepsy
* Caregiver participant who is currently experiencing a major depressive disorder, panic disorder (only if ≥ 4 nocturnal panic attacks in the past month), or post-traumatic stress-related problems
* Caregiver participant who is using medications or substances that directly affect sleep
* Caregiver participant who is currently getting cognitive behavioral therapy for insomnia (CBTi)
* Pregnant women
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
24 Months
Study:
NCT05806450
Study Brief:
Protocol Section:
NCT05806450