NCT05726890 Examining the Effectiveness of Two Behavioral Interventions for Sleep Problems in Infants
| NCT ID | NCT05726890 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ben-Gurion University of the Negev |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2023-03-09 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 270 participants in total. It began in 2023-03-09 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Behavioral insomnia of childhood affects 15-30% of infants. Behavioral interventions, based on limiting parent-child bedtime and nighttime interactions, are effective in significantly improving infant sleep problems. However, the implementation of these interventions frequently encompasses significant infant crying and parental distress that deter many parents. Research on gradual sleep interventions that involve a lower "dose" of parent-infant separation, and thus may be more acceptable by parents, has so far been sparse. The proposed study aims to advance research in this area through systematically studying the processes through which parent and infant factors impact treatment outcomes of a behavioral intervention method that involves parent-infant separation only at bedtime ("bedtime checking"), in comparison to an intervention that also directly targets night-wakings ("standard checking"/"graduated extinction").
Eligibility 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).
Contact & Investigator
Liat Tikotzky, PhD
PRINCIPAL INVESTIGATOR
Ben-Gurion University of the Negev
Frequently Asked Questions
Who can join the NCT05726890 clinical trial?
This trial is open to participants of all sexes, aged 9 Months or older, up to 18 Months, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05726890 currently recruiting?
Yes, NCT05726890 is actively recruiting participants. Contact the research team at liatti@bgu.ac.il for enrollment information.
Where is the NCT05726890 trial being conducted?
This trial is being conducted at Beersheba, Israel.
Who is sponsoring the NCT05726890 clinical trial?
NCT05726890 is sponsored by Ben-Gurion University of the Negev. The principal investigator is Liat Tikotzky, PhD at Ben-Gurion University of the Negev. The trial plans to enroll 270 participants.
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