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Clinical Trials/NCT03419871
NCT03419871
Completed
Not Applicable

Sleep, Biological Stress, and Health Among Toddlers Living in Socioeconomically Disadvantaged Homes

Yale University1 site in 1 country100 target enrollmentNovember 8, 2015
ConditionsSleep Disorder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Disorder
Sponsor
Yale University
Enrollment
100
Locations
1
Primary Endpoint
Caregiver report
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

A longitudinal study to examine the relationships among sleep characteristics, stress, and child behavior problems in a community sample of toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes

Detailed Description

The purpose of this study is to examine the relationships among sleep characteristics, stress (allostatic load), and health among toddlers living in economically stressed communities. Sleep difficulty, including short sleep duration and poor sleep efficiency, is closely related to measures of stress, including interleukin (IL-6), cortisol, c-reactive proteins (CRP), secretory immunoglobulin A (SIgA), and body mass index (BMI) and may therefore contribute to 'wear and tear' on the body (allostatic load), a problem that places children at high risk of physical and mental health problems. Young children who live with socioeconomic adversity are especially vulnerable to both sleep difficulty and higher levels of physiologic stress (allostatic load).

Registry
clinicaltrials.gov
Start Date
November 8, 2015
End Date
October 15, 2019
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes.

Exclusion Criteria

  • If the toddler has a diagnosis of sleep apnea or has another documented medical condition affecting sleep.

Outcomes

Primary Outcomes

Caregiver report

Time Frame: 12 to 36 months

Caregivers will complete the Brief Infant Sleep Questionnaire

Behavioral monitoring

Time Frame: 12 to 36 months

Toddler behavior problems will be assessed using the Brief Infant Toddler Social and Emotional Assessment (BITSEA).

Sleep monitoring

Time Frame: 9 days

Sleep characteristics will be measured by an accelerometer on the wrist or ankle to measure sleep efficiency.

Sleep diary

Time Frame: 12 to 24 months

Caregivers will complete a sleep diary to record their toddler's sleep for time period when an accelerometer will be worn by the child.

Secondary Outcomes

  • Immune biomarkers(12 to 24 months)
  • Anthropometric biomarkers(12 to 24 months)
  • Cortisol biomarker(12 to 24 months)

Study Sites (1)

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