Examining two behavioral methods to improve sleep in infants
Early Childhood Insomnia: Underlying Mechanisms of Intervention Effects of the "Bedtime Checking" and the "Standard Checking" Methods
This study is testing two different ways to help infants with insomnia sleep better, comparing a method that involves checking on them at bedtime to a standard method that also helps with waking up at night.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 9 Months to 18 Months |
| Sex | All |
| Sponsor | Ben-Gurion University of the Negev Academic / other |
| Locations | 1 site (Beersheba) |
| Trial ID | NCT05726890 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of two behavioral interventions aimed at addressing insomnia in infants. It compares a 'bedtime checking' method, which involves minimal parent-infant separation at bedtime, to a 'standard checking' method that also addresses night-wakings. The study will recruit 230 infants diagnosed with early-childhood insomnia and their parents, assessing sleep through actigraphy, videosomnography, and sleep logs. Additionally, parental emotional distress and infant temperament will be evaluated to understand their impact on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are Hebrew-speaking, two-parent families with infants diagnosed with early-childhood insomnia who wish to promote independent sleep for their child.
Not a fit: Patients with significant physiological sleep problems or chronic health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more acceptable and effective approach for parents to help their infants sleep better.
How similar studies have performed: While behavioral interventions for infant sleep issues have been studied, the specific focus on gradual sleep interventions with lower parental distress is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Early-childhood insomnia according to DSM-5 criteria * The parents wish to sleep independently from the child and would like the infant to need as little help as possible to fall asleep or stay asleep * Two-parent, Hebrew-speaking families. * Infants born at term (gestational age \> 36 weeks) Exclusion Criteria: * Infants and parents with significant physiological sleep problems (e.g., sleep apnea) * Infants and parents with any chronic health problems (based on self-report).
Where this trial is running
Beersheba
- Ben-Gurion University of the Negev — Beersheba, Israel (Recruiting)
Study contacts
- Principal investigator: Liat Tikotzky, PhD — Ben-Gurion University of the Negev
- Study coordinator: Liat Tikotzky, PhD
- Email: liatti@bgu.ac.il
- Phone: +972545497243
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.