An interventional study of Bedtime routine and Sleep schedule in Insomnia, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 6 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-18.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Infant sleep monitoring and parental surveys 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.
Behavioral: Bedtime routine · Behavioral: Sleep schedule · Behavioral: Intervention (bedtime)
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)
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.
Infant sleep (subjective)
Total score on Infant Sleep Questionnaire (ISQ; range=0-38; higher score indicate more problematic sleep)
Time frame: Change in score from baseline (day 2, prior to the start of intervention) to post-intervention (day 16)
Infant sleep (objective): wake after sleep onset
Wake after sleep onset in minutes (assessed via videosomnography)
Time frame: 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
Wake after sleep onset in minutes (assessed via parent report on sleep diary)
Time frame: 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
Longest sleep period in minutes (assessed via videosomnography)
Time frame: 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
Longest sleep period in minutes (assessed via parent report on sleep diary)
Time frame: Average per night from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Parental stress
Daily parental rating of nightly stress associated with their infant's sleep
Time frame: Average from nights 1-3 (baseline) compared to average from nights 15-17 (2 weeks later; after intervention)
Parental mood
Profile of Mood State - 2nd edition, total score
Time frame: Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)
Parental sleep
Pittsburgh Sleep Quality Index, total score
Time frame: Baseline (day 2, prior to the start of intervention) compared to post-intervention (day 16)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Indiana University