Sleep Disorder Clinical Trial
Official title:
Sleep, Biological Stress, and Health Among Toddlers Living in Socioeconomically Disadvantaged Homes
Verified date | December 2021 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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
Status | Completed |
Enrollment | 100 |
Est. completion date | October 15, 2019 |
Est. primary completion date | October 15, 2019 |
Accepts healthy volunteers | |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Yale New Haven Hospital Primary Care Center | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
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 |
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