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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03419871
Enrollment
100
Registered
2018-02-05
Start date
2015-11-08
Completion date
2019-10-15
Last updated
2021-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorder

Keywords

economically stressed communities

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).

Interventions

OTHERMonitoring Sleep

An 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.

Salivary 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.

Sponsors

Yale University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Months to 15 Months

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.

Design outcomes

Primary

MeasureTime frameDescription
Sleep monitoring9 daysSleep characteristics will be measured by an accelerometer on the wrist or ankle to measure sleep efficiency.
Caregiver report12 to 36 monthsCaregivers will complete the Brief Infant Sleep Questionnaire
Sleep diary12 to 24 monthsCaregivers will complete a sleep diary to record their toddler's sleep for time period when an accelerometer will be worn by the child.
Behavioral monitoring12 to 36 monthsToddler behavior problems will be assessed using the Brief Infant Toddler Social and Emotional Assessment (BITSEA).

Secondary

MeasureTime frameDescription
Immune biomarkers12 to 24 monthsA 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 biomarkers12 to 24 monthsAnthropometrics - Body Mass Index (BMI)
Cortisol biomarker12 to 24 monthsA 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026