Skip to main content
OpenTrials
Completed

NCT Number: NCT02398214

A Sleep Hygiene-based Intervention Program for Infants and Toddlers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

6 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 10048, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Hygiene

Behavioral

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.

Primary outcomes

  1. Actigraphic assessed sleep quantity variables

    Time frame: Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up

    Total nighttime, daytime, and 24 hour sleep duration

Secondary outcomes

  1. Actigraphic assessed sleep quality variables

    Time frame: Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up

    Sleep onset latency and wake after sleep onset

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 25, 2015
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.