Infant Behavioral Sleep Intervention: Comparative Efficacy

NCT03447665 | Completed

• 1 other identifier: VFR-43-Honaker
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Insomnia

Keywords

Infant behavioral sleep intervention; Infant sleep; Pediatric insomnia; Infant night wakings

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Infant sleep (objective): wake after sleep onset

  Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)

• Infant sleep (subjective): wake after sleep onset

  Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)

• Infant sleep (objective): longest sleep period

  Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)

• Infant sleep (subjective): longest sleep period

  Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)

• Parental stress

  Average from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)

Study Arms (3)

Control

NO INTERVENTION

Infant sleep monitoring and parental surveys only

Intervention (Bedtime only)

EXPERIMENTAL

Infant behavioral sleep intervention implemented at bedtime only. Parents are instructed to soothe/help their infant back to sleep after night wakings. Includes a tailored sleep schedule and bedtime routine, as well as support from a sleep interventionist.

Behavioral: Bedtime routine; Behavioral: Sleep schedule; Behavioral: Intervention (bedtime)

Intervention (All night)

EXPERIMENTAL

Infant behavioral sleep intervention implemented at bedtime and after each subsequent infant night waking. Includes a tailored sleep schedule and bedtime routine, as well as support from a sleep interventionist.

Behavioral: Bedtime routine; Behavioral: Sleep schedule; Behavioral: Intervention (bedtime); Behavioral: Intervention (after night wakings)

Interventions

Bedtime routine BEHAVIORAL

Tailored bedtime routine

Intervention (All night); Intervention (Bedtime only)

Sleep schedule BEHAVIORAL

Tailored sleep schedule, including morning rise time, cut-off for last nap of the day, and bedtime.

Intervention (All night); Intervention (Bedtime only)

Intervention (bedtime) BEHAVIORAL

Parents implement behavioral sleep intervention at bedtime.

Intervention (All night); Intervention (Bedtime only)

Intervention (after night wakings) BEHAVIORAL

Parents implement behavioral sleep intervention following each night waking.

Intervention (All night)

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Indiana University: lead
• Purdue University: collaborator
• Saint-Joseph University: collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individuals coding videosomnography are blinded to the participant's condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: Families are randomly assigned to one of three groups: control, bedtime only (intervention), or all night (intervention).

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 27, 2018
• Study Start: February 1, 2018
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)