Associations of Socioeconomic Adversity and Sleep With Allostatic Load Among Toddlers

NCT ID: NCT03419871

Last Updated: 2021-12-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-08
• Study Completion Date: 2019-10-15

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).

Conditions

Sleep Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

monitoring sleep effects on toddlers

Monitoring the sleep characteristics of toddlers living in economically stressed communities.

Monitoring Sleep

Intervention Type: 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

Intervention Type: 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.

Interventions

Monitoring 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.

Intervention Type: OTHER

stress biomarkers

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 15 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica Ordway, Phd

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Nursing

Locations

Yale New Haven Hospital Primary Care Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1504015764

Identifier Type: -

Identifier Source: org_study_id