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Completed

NCT Number: NCT03419871

Associations of Socioeconomic Adversity and Sleep With Allostatic Load Among Toddlers

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

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Key information

Conditions

Sleep Disorder Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Hospital Primary Care Center

New Haven, Connecticut, 06510, United States

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Monitoring Sleep

Other

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.

stress biomarkers

Other

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.

Primary outcomes

  1. Sleep monitoring

    Time frame: 9 days

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

  2. Caregiver report

    Time frame: 12 to 36 months

    Caregivers will complete the Brief Infant Sleep Questionnaire

  3. 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.

  4. Behavioral monitoring

    Time frame: 12 to 36 months

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

Secondary outcomes

  1. Cortisol biomarker

    Time frame: 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.

  2. Immune biomarkers

    Time frame: 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.

  3. Anthropometric biomarkers

    Time frame: 12 to 24 months

    Anthropometrics - Body Mass Index (BMI)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2018
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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