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Infant Behavioral Sleep Intervention: Comparative Efficacy

NCT03447665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-04-18

No results posted yet for this study

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

Interventions

BEHAVIORAL

Bedtime routine

Tailored bedtime routine

BEHAVIORAL

Sleep schedule

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

BEHAVIORAL

Intervention (bedtime)

Parents implement behavioral sleep intervention at bedtime.

BEHAVIORAL

Intervention (after night wakings)

Parents implement behavioral sleep intervention following each night waking.

Sponsors & Collaborators

  • Purdue University

    collaborator OTHER

  • Saint-Joseph University

    collaborator OTHER

  • Indiana University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2019-04-10
Completion
2019-04-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03447665 on ClinicalTrials.gov