Associations of Socioeconomic Adversity and Sleep With Allostatic Load Among Toddlers

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419871
• Other study ID #: 1504015764
• Status: Completed
• Start date: November 8, 2015
• Est. completion date: October 15, 2019

Study information

• Verified date: December 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Gender: All
• Age group: 12 Months to 15 Months

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Disorder
• Sleep Wake Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital Primary Care Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep monitoring	Sleep characteristics will be measured by an accelerometer on the wrist or ankle to measure sleep efficiency.	9 days
Primary	Caregiver report	Caregivers will complete the Brief Infant Sleep Questionnaire	12 to 36 months
Primary	Sleep diary	Caregivers will complete a sleep diary to record their toddler's sleep for time period when an accelerometer will be worn by the child.	12 to 24 months
Primary	Behavioral monitoring	Toddler behavior problems will be assessed using the Brief Infant Toddler Social and Emotional Assessment (BITSEA).	12 to 36 months
Secondary	Cortisol biomarker	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.	12 to 24 months
Secondary	Immune biomarkers	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.	12 to 24 months
Secondary	Anthropometric biomarkers	Anthropometrics - Body Mass Index (BMI)	12 to 24 months