A Sleep Hygiene-based Intervention Program for Infants and Toddlers

Sleep Clinical Trial

Official title:

A Sleep Hygiene-based Intervention Program for Infants and Toddlers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398214
• Other study ID #: 201203083RIC
• Status: Completed
• Phase: N/A
• First received: March 8, 2015
• Last updated: April 14, 2017
• Start date: November 2012
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• Sleep 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actigraphic assessed sleep quantity variables	Total nighttime, daytime, and 24 hour sleep duration	Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up
Secondary	Actigraphic assessed sleep quality variables	Sleep onset latency and wake after sleep onset	Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up