Clinical Trials Directory

Trials / Completed

CompletedNCT03419871

Associations of Socioeconomic Adversity and Sleep With Allostatic Load Among Toddlers

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

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Yale University · Academic / Other
Sex
All
Age
12 Months – 15 Months
Healthy volunteers

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).

Conditions

Interventions

TypeNameDescription
OTHERMonitoring SleepAn accelerometer will be placed on the wrist or ankle of the child while the child sleeps in their home. Caregivers will be instructed to keep the accelerometer on their toddler's ankle to measure sleep duration, latency and sleep efficiency. Seven nights of data will be obtained because actigraphy is most reliably measured in young children over this time frame.
OTHERstress biomarkersSalivary and hair cortisol measurements were used to obtain a change in baseline from 12 to 24 months. Data on the timing of the saliva collection will be collected using a Medical Electronic Monitoring System (MEMScapTM) - a digital memory cap that records the timing and frequency of opening. Cortisol will be measure in the morning and bedtime samples. A small amount of hair (30mg) will be cut from the posterior vertex of the child's head. Due to the expected variability in hair length of toddlers, documentation of hair length will be completed. Each centimeter represents 1 month history of stress and ideally 3 cm of hair length will be collected to provide a three month history of stress.

Timeline

Start date
2015-11-08
Primary completion
2019-10-15
Completion
2019-10-15
First posted
2018-02-05
Last updated
2021-12-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03419871. Inclusion in this directory is not an endorsement.