Associations of Socioeconomic Adversity and Sleep With Allostatic Load Among Toddlers

Completed

• Conditions: Sleep Disorder
• Interventions: Other: Monitoring Sleep; Other: stress biomarkers

• Registration Number: NCT03419871
• Lead Sponsor: Yale University

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).

Study Timeline

• Study Start: 2015-11-08
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-02-05
• Primary Completion: 2019-10-15
• Study Completion: 2019-10-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
monitoring sleep effects on toddlers	Monitoring Sleep	Monitoring the sleep characteristics of toddlers living in economically stressed communities.
monitoring sleep effects on toddlers	stress biomarkers	Monitoring the sleep characteristics of toddlers living in economically stressed communities.

Primary Outcome Measures

Name	Time	Method
Caregiver report	12 to 36 months	Caregivers will complete the Brief Infant Sleep Questionnaire
Behavioral monitoring	12 to 36 months	Toddler behavior problems will be assessed using the Brief Infant Toddler Social and Emotional Assessment (BITSEA).
Sleep monitoring	9 days	Sleep characteristics will be measured by an accelerometer on the wrist or ankle to measure sleep efficiency.
Sleep diary	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 Outcome Measures

Name	Time	Method
Immune biomarkers	12 to 24 months	A secretory antibody immunoglobulins A and secretory immunoglobulins A ( IgA ,S-IgA) that plays an integral role in the maintenance of mucosal homeostasis and is associated with increased risk of infection will be measured.
Anthropometric biomarkers	12 to 24 months	Anthropometrics - Body Mass Index (BMI)
Cortisol biomarker	12 to 24 months	A small amount of hair (30mg) will be cut from the posterior vertex of the child's head. The samples will be tied together with the scalp end noted.

Trial Locations

Locations (1)

Yale New Haven Hospital Primary Care Center; 🇺🇸 New Haven, Connecticut, United States