Actively Recruiting
Association Between Sleep and Psychomotor Development in Early Childhood
Led by Universidade do Porto · Updated on 2025-02-10
119
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
U
Universidade do Porto
Lead Sponsor
C
Centro Hospitalar De São João, E.P.E.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying sleep patterns and their connection to psychomotor and physical growth in Portuguese children aged 2 to 4 years. This observational study aims to fill the gap in recent data about how children sleep in Portugal and to understand how sleep affects healthy development. The findings may help promote better sleep habits through education for parents, teachers, and policymakers. Participants will be observed using tools like actigraphy, which tracks sleep rhythms, and the Schedule of Growing Skills II, which assesses developmental skills. Sleep habits will be evaluated with a questionnaire validated for Portuguese children, and melatonin levels will be measured from first-morning urine samples. These assessments will be done at ages 24 to 30 months, 3 years, and 4 years to monitor changes over time. During the study, children will undergo evaluations at these three time points to track sleep hygiene, psychomotor development, melatonin levels, body mass index, and frequency of infections. The study involves no treatment but careful observation and data collection to understand the relationships between sleep and development. Participation will last until the child reaches 4 years of age, with ongoing monitoring to gather comprehensive information.
CONDITIONS
Brief Title
Association Between Sleep and Psychomotor Development in Early Childhood
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged between 2 years and 6 months at the first assessment
- Gestational age at birth of 37 weeks or more
- Delivery without serious complications for the child
- No developmental pathologies or conditions affecting psychomotor development
You will not qualify if you...
- Severe growth restriction despite non-preterm birth
- Diagnosis of psychomotor development pathology
- Diagnosis of any condition interfering with psychomotor development
- Taking daily medications except vitamin supplements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At 24 to 30 months of age, at 3 years of age, and at 4 years of age
Participants undergo assessments of sleep patterns, psychomotor development, sleep hygiene, and melatonin levels using actigraphy, questionnaires, and urine samples.
3 visits (in-person) at specified ages
Duration - From 24 to 30 months through 4 years of age
Participants are observed for body mass index and number of infectious events during the study period.
3 visits (in-person) coinciding with evaluation timepoints
Trial Site Locations
Total: 1 location
1
Faculty of Medicine (FMUP)
Porto, Portugal, 4200-319
Actively Recruiting
Research Team
A
Andreia Neves, PhDc
J
Janete Santos, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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