Sleep DisorderNCT03419871
Associations of Socioeconomic Adversity and Sleep With Allostatic Load Among Toddlers
An observational study of Sleep Disorder, run by Yale University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 12 to 15 months
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Monitoring Sleep and stress biomarkers
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2015to 15 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 months
- All sexes
- Child
Study population: Toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes.
Who may be able to join
- Toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes.
Who cannot join
- If the toddler has a diagnosis of sleep apnea or has another documented medical condition affecting sleep.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital Primary Care Center
New Haven, Connecticut, 06510
About this study
Official title: Sleep, Biological Stress, and Health Among Toddlers Living in Socioeconomically Disadvantaged Homes
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
Read the 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
- Being tested
- Monitoring Sleep, stress biomarkers
- Keywords
- economically stressed communities
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring SleepOther
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 biomarkersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| monitoring sleep effects on toddlers | Monitoring the sleep characteristics of toddlers living in economically stressed communities. Receives: Other: Monitoring Sleep; Other: stress biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep monitoring
Sleep characteristics will be measured by an accelerometer on the wrist or ankle to measure sleep efficiency.
Measured: 9 days
Caregiver report
Caregivers will complete the Brief Infant Sleep Questionnaire
Measured: 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.
Measured: 12 to 24 months
Behavioral monitoring
Toddler behavior problems will be assessed using the Brief Infant Toddler Social and Emotional Assessment (BITSEA).
Measured: 12 to 36 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 12 to 24 months
Anthropometric biomarkers
Anthropometrics - Body Mass Index (BMI)
Measured: 12 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start8 Nov 2015
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica Ordway, Phd, Principal investigator, Yale University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419871
- Sponsor's protocol ID
- 1504015764
- Status last verified
- Dec 2021
- First submitted
- 19 Dec 2017
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Biological Stress, and Health Among Toddlers Living in Socioeconomically Disadvantaged Homes
- ClinicalTrials.gov ID
- NCT03419871
- Acronym / sponsor ID
- 1504015764
- Conditions
- Sleep Disorder
- Keywords
- economically stressed communities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 8 Nov 2015 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| monitoring sleep effects on toddlers | – | Other: Monitoring Sleep, Other: stress biomarkersMonitoring the sleep characteristics of toddlers living in economically stressed communities. |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Age groups
- Child
- Study population
- Toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes.
Key inclusion criteria (1 listed)
- Toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes.
Key exclusion criteria (1 listed)
- If the toddler has a diagnosis of sleep apnea or has another documented medical condition affecting sleep.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring SleepAn 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 | monitoring sleep effects on toddlers |
| stress biomarkersSalivary 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. | Other | monitoring sleep effects on toddlers |
Primary outcome
Sleep monitoring
Time frame: 9 days
Sleep characteristics will be measured by an accelerometer on the wrist or ankle to measure sleep efficiency.
Caregiver report
Time frame: 12 to 36 months
Caregivers will complete the Brief Infant Sleep Questionnaire
Sleep diary
Time frame: 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
Time frame: 12 to 36 months
Toddler behavior problems will be assessed using the Brief Infant Toddler Social and Emotional Assessment (BITSEA).
3 secondary outcomes
Cortisol biomarker
Time frame: 12 to 24 months
Immune biomarkers
Time frame: 12 to 24 months
Anthropometric biomarkers
Time frame: 12 to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Ordway, Phd principal investigator
Yale University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep monitoring (time frame: 9 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.