Status:
COMPLETED
Infant Behavioral Sleep Intervention: Comparative Efficacy
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Purdue University
Saint-Joseph University
Conditions:
Insomnia
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
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 throughou...
Detailed Description
Study Design: Randomized controlled trial (RCT). Approximately thirty participants will be randomized to a control condition or one of two intervention conditions. Participants: Participants are heal...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03447665
Start Date
February 1 2018
End Date
April 10 2019
Last Update
April 18 2019
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202