Associations of Socioeconomic Adversity and Sleep With Allostatic Load Among Toddlers

NCT03419871 | Completed

• 1 other identifier: 1504015764
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Disorder

Keywords

economically stressed communities

Outcome Measures

Primary Outcomes (4)

• Sleep monitoring

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

  9 days

• Caregiver report

  Caregivers will complete the Brief Infant Sleep Questionnaire

  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.

  12 to 24 months

• Behavioral monitoring

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

  12 to 36 months

Secondary Outcomes (3)

• Cortisol biomarker

  12 to 24 months

• Immune biomarkers

  12 to 24 months

• Anthropometric biomarkers

  12 to 24 months

Study Arms (1)

monitoring sleep effects on toddlers

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

Other: Monitoring Sleep; Other: stress biomarkers

Interventions

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.

monitoring sleep effects on toddlers

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.

monitoring sleep effects on toddlers

Eligibility Criteria

• Age: 12 Months - 15 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes.

You may qualify if:

• Toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes.

You may not qualify if:

• If the toddler has a diagnosis of sleep apnea or has another documented medical condition affecting sleep.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital Primary Care Center

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Monica Ordway, Phd

  Yale University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: February 5, 2018
• Study Start: November 8, 2015
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: December 7, 2021

Record last verified: 2021-12

Locations

US (1)