An observational study in Sleep Disorder, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 12 Months to 15 Months. Per ClinicalTrials.gov, last updated 2021-12-07.
Sponsored by Yale University · Observational
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
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).
Toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes.
Exclusion Criteria:
Monitoring the sleep characteristics of toddlers living in economically stressed communities.
Other: Monitoring Sleep · Other: stress biomarkers
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.
Sleep monitoring
Sleep characteristics will be measured by an accelerometer on the wrist or ankle to measure sleep efficiency.
Time frame: 9 days
Caregiver report
Caregivers will complete the Brief Infant Sleep Questionnaire
Time frame: 12 to 36 months
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.
Time frame: 12 to 24 months
Behavioral monitoring
Toddler behavior problems will be assessed using the Brief Infant Toddler Social and Emotional Assessment (BITSEA).
Time frame: 12 to 36 months
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.
Time frame: 12 to 24 months
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.
Time frame: 12 to 24 months
Anthropometric biomarkers
Anthropometrics - Body Mass Index (BMI)
Time frame: 12 to 24 months
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Yale University