Infant Behavioral Sleep Intervention: Comparative Efficacy

Insomnia Clinical Trial

Official title:

Infant Behavioral Sleep Intervention: Comparative Efficacy Across Two Approaches "The Sleeping Baby Study"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447665
• Other study ID #: VFR-43-Honaker
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: April 10, 2019

Study information

• Verified date: April 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 healthy infants between the ages of 6 and 18 months who wake during the night, and their parents. Parents must be willing to engage in infant behavioral sleep intervention.

Study Procedure: Participant recruitment strategies include direct referrals from community primary care providers (PCP)s, signs posted in medical offices, and social media posts. Participants will be screened and consented via phone. Team members will conduct three home visits with participating families to install videorecording device and actigraphy and take a sleep history (Visit 1); teach families the intervention (Visit 2); and remove monitoring equipment and offer intervention to families in the control condition (Visit 3). Parents will be asked to complete daily sleep logs and three sets of surveys using REDCap.

Intervention: The intervention consists of an infant behavioral sleep protocol. For both intervention conditions an interventionist will collaborate with the family to design a tailored sleep schedule and bedtime routine. The interventionist will then teach the family a behavioral approach, which involves placing the infant in his/her crib awake, and leaving the room. The behavioral approach will be individually tailored for each family (e.g., periodic checks). The two intervention conditions differ in regards to the timing of the intervention. In the all night condition, which represents a standard intervention approach, parents are asked to implement the behavioral protocol at bedtime and at subsequent night wakings. In the bedtime only condition, parents are asked to implement the behavioral protocol at bedtime only, and to soothe their infant back to sleep following night wakings.

Measures: Infant sleep will be assessed via parent-report (sleep diary and validated measure); actigraphy; and videosomnography. Parent sleep, parent mood, and infant mood will be assessed via validated parental-report survey measures.

Collaborators on this study include: AJ Schwichtenberg, Purdue University; Jodi Mindell, Saint Joseph University.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 10, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 18 Months

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Bedtime routine
Tailored bedtime routine
• Sleep schedule
Tailored sleep schedule, including morning rise time, cut-off for last nap of the day, and bedtime.
• Intervention (bedtime)
Parents implement behavioral sleep intervention at bedtime.
• Intervention (after night wakings)
Parents implement behavioral sleep intervention following each night waking.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Purdue University, Saint-Joseph University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant sleep (subjective)	Total score on Infant Sleep Questionnaire (ISQ; range=0-38; higher score indicate more problematic sleep)	Change in score from baseline (day 2, prior to the start of intervention) to post-intervention (day 16)
Secondary	Infant sleep (objective): wake after sleep onset	Wake after sleep onset in minutes (assessed via videosomnography)	Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Secondary	Infant sleep (subjective): wake after sleep onset	Wake after sleep onset in minutes (assessed via parent report on sleep diary)	Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Secondary	Infant sleep (objective): longest sleep period	Longest sleep period in minutes (assessed via videosomnography)	Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Secondary	Infant sleep (subjective): longest sleep period	Longest sleep period in minutes (assessed via parent report on sleep diary)	Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Secondary	Parental stress	Daily parental rating of nightly stress associated with their infant's sleep	Average from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Secondary	Parental mood	Profile of Mood State - 2nd edition, total score	Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)
Secondary	Parental sleep	Pittsburgh Sleep Quality Index, total score	Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)