Infant Behavioral Sleep Intervention: Comparative Efficacy

Completed · Not applicable

Conditions studied: Insomnia

In brief

While frequent night awakenings in newborns are common and expected, an estimated 20-30% of older infants and toddlers have frequent problematic night wakings requiring parental intervention throughout the night. Standard infant behavioral sleep intervention approaches, which require parental intervention throughout the night, are effective but often difficult for families to implement. The aim of this study is to compare the efficacy of two infant behavioral sleep interventions with a no treatment condition, on infant sleep and family functioning. Healthy infants between the ages of 6 and 18 months with night wakings will be randomized into one of three conditions: Entire night intervention, bedtime only intervention, or no treatment.

Key facts

Study ID

NCT03447665

Run by

Indiana University

People needed

30

Starts

2018-02-01

Expected to finish

2019-04-10

Last updated by the study team

2019-04-18

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Infant has disruptive night wakings (wakes 1x or more/night, 5+ nights per wk; caregiver intervenes at night wakings)
• Infant is placed in bed asleep in a crib/bassinet or similar at bedtime at least five nights per week
• Parent/caregiver goal is for the infant to fall asleep independently at bedtime and/or return to sleep independently during the night
• Parent/caregiver goal is for the infant to sleep in crib or similar
• Parent/caregiver lives in the home with the infant, is typically at home at the time of the infant's typical bedtime at least 5 nights a week, and is primary caregiver at bedtime and during the night.
• The family must have in-home private wireless access that they are willing to share with the study team (necessary for streaming video)
• Families lives in Indianapolis, Indiana or surrounding areas (within 50 miles of Indiana University School of Medicine)

You may not qualify if…

• Infant has a chronic major medical condition that affects sleep
• Infant has a major developmental condition (e.g. Down syndrome)
• Family is already receiving professional help for the infant's sleep problems
• Infant snores 5+ nights per week (in which case a sleep study will be recommended; families could participate in the study following a negative sleep study.)
• Infant has chronic skin conditions (e.g. eczema) that would prohibit wearing an actigraph on the leg

Where it is running

• Indiana University School of Medicine — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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