Associations of Socioeconomic Adversity and Sleep With Allostatic Load Among Toddlers

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT03419871

Collaborator

(none)

100

Enrollment

Location

47.2

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorder	Other: Monitoring Sleep Other: stress biomarkers

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 Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 8, 2015

Actual Primary Completion Date :

Oct 15, 2019

Actual Study Completion Date :

Oct 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
monitoring sleep effects on toddlers Monitoring the sleep characteristics of toddlers living in economically stressed communities.	Other: 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. 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.

Arm

Intervention/Treatment

monitoring sleep effects on toddlers

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

Other: 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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 15 Months

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale New Haven Hospital Primary Care Center	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator: Monica Ordway, Phd, Yale University School of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yale University

ClinicalTrials.gov Identifier:

NCT03419871

Other Study ID Numbers:

1504015764

First Posted:

Feb 5, 2018

Last Update Posted:

Dec 7, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yale University

economically stressed communities

Additional relevant MeSH terms:

Sleep Wake Disorders

Study Results

No Results Posted as of Dec 7, 2021