Skip to content

A Sleep Hygiene-based Intervention Program for Infants and Toddlers

A Sleep Hygiene-based Intervention Program for Infants and Toddlers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02398214
Enrollment
247
Registered
2015-03-25
Start date
2012-11-30
Completion date
2016-12-31
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

Sleep, Infants, Toddlers, Behavioral intervention

Brief summary

Sleep problems during infancy are associated with behavior and emotional problems, poor language development , parental distress and mood disturbances, and overweight and obese children. The investigators proposed that children who receive the light, activity, and sleep training (LAST) intervention program in this study will have less parent report of problem sleep behaviors and longer duration of nighttime sleep compared to children with no intervention provided.

Detailed description

Sleep problems are reported in 71.65% of our nation's infants and toddlers, and the prevalence is much higher than the 20-30% reported in Western countries. The investigators' preliminary findings also show that approximately 53-55% of parents of children between 6 and 12 months of age consider their child sleep a problem with about 4% not knowing whether their child sleep is a problem. Sleep development during infancy is characterized by increasing day-night differences in sleep-wakefulness such as longer bouts of sleep and fewer awakenings at night, and is driven by neurobiological maturation and environmental interactions. By 3 months of age, nearly 58% of infants can sleep continuously between 24:00-05:00 hours. When infants do not sleep through the night by 17 months of age, they are less likely to be able to do so at 29 months of age and beyond. Without proper intervention, sleep problems during infancy can persist to toddler and preschool age. Various interventions have been developed and tested in Western and Asian Countries to address the sleep problems in infants and young children, but none are in Taiwan.

Interventions

BEHAVIORALSleep hygiene

LAST intervention (light, activity, and sleep training) consists of behavioral and educational strategies for increasing light exposure and physical activity, minimizing television viewing and reducing television viewing time to \< 2 hours per day, and engaging activities suitable to the child's motor development to minimize sleep disturbance.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 2 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy singleton infant born at gestational age \>= 37 weeks

Exclusion criteria

* Infants born before 37 weeks gestation * Infants born with a congenital abnormality or a genetic disorder * Parents with insufficient Chinese

Design outcomes

Primary

MeasureTime frameDescription
Actigraphic assessed sleep quantity variablesBaseline, 6-month follow-up, 12-month follow-up, and 18-month follow-upTotal nighttime, daytime, and 24 hour sleep duration

Secondary

MeasureTime frameDescription
Actigraphic assessed sleep quality variablesBaseline, 6-month follow-up, 12-month follow-up, and 18-month follow-upSleep onset latency and wake after sleep onset

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026