- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03447665
Infant Behavioral Sleep Intervention: Comparative Efficacy
Infant Behavioral Sleep Intervention: Comparative Efficacy Across Two Approaches "The Sleeping Baby Study"
Study Overview
Status
Conditions
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Infant sleep monitoring and parental surveys only
|
|
Experimental: Intervention (Bedtime only)
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.
|
Tailored bedtime routine
Tailored sleep schedule, including morning rise time, cut-off for last nap of the day, and bedtime.
Parents implement behavioral sleep intervention at bedtime.
|
Experimental: Intervention (All night)
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.
|
Tailored bedtime routine
Tailored sleep schedule, including morning rise time, cut-off for last nap of the day, and bedtime.
Parents implement behavioral sleep intervention at bedtime.
Parents implement behavioral sleep intervention following each night waking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant sleep (subjective)
Time Frame: Change in score from baseline (day 2, prior to the start of intervention) to post-intervention (day 16)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant sleep (objective): wake after sleep onset
Time Frame: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
|
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)
|
Infant sleep (subjective): wake after sleep onset
Time Frame: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
|
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)
|
Infant sleep (objective): longest sleep period
Time Frame: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
|
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)
|
Infant sleep (subjective): longest sleep period
Time Frame: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
|
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)
|
Parental stress
Time Frame: Average from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
|
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)
|
Parental mood
Time Frame: Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)
|
Profile of Mood State - 2nd edition, total score
|
Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)
|
Parental sleep
Time Frame: Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)
|
Pittsburgh Sleep Quality Index, total score
|
Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VFR-43-Honaker
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Insomnia
-
National Yang Ming UniversityBened Biomedical Co., Ltd.Not yet recruiting
-
Leiden University Medical CenterNot yet recruiting
-
Weill Medical College of Cornell UniversityMARPACCompleted
-
Regenstrief Institute, Inc.Merck Sharp & Dohme LLC; National Sleep FoundationUnknownInsomniaUnited States
-
Posit Science CorporationUniversity of California, San FranciscoCompleted
-
University of UtahNational Center for Complementary and Integrative Health (NCCIH)Completed
-
Minneapolis Veterans Affairs Medical CenterWithdrawn
-
GlaxoSmithKlineWithdrawn
-
Coeruleus Ltd.Completed
-
PfizerCompleted
Clinical Trials on Bedtime routine
-
National Taiwan UniversityCompleted
-
Saint Joseph's University, PhiladelphiaJohnson & Johnson Consumer Inc. (J&JCI); Temple University; Simms/Mann Family... and other collaboratorsCompletedSleep | Sleep Disturbance | Child DevelopmentUnited States
-
University of ChicagoNational Heart, Lung, and Blood Institute (NHLBI)CompletedSleep | Insulin Resistance | Type 2 Diabetes | Sleep DeprivationUnited States
-
University of ChicagoCompleted
-
University of AarhusUniversity of Oxford; University Hospital Heidelberg; Sygekassernes Helsefond; University...Completed
-
Rush University Medical CenterCompleted
-
McGill UniversityCanadian Diabetes AssociationCompletedType 1 Diabetes MellitusCanada
-
Indiana UniversityTerminatedSleep Hygiene, InadequateUnited States
-
Ben-Gurion University of the NegevRecruiting
-
University of LeipzigRecruiting