Association Between Sleep and Psychomotor Development in Early Childhood (SleePsy)

Sleep is a neurophysiological active process essential for healthy physical and cognitive development. In Portugal, there is no recent and objective data on how children sleep.

Given the importance of sleep in child health and development as well as the health gains achieved by establishing healthy sleep patterns since childhood, it seems extremely relevant to assess the various sleep parameters of Portuguese children and correlate them with their psychomotor and anthropometric development indicators. The results of this research work may support the implementation of sleep health education measures among parents, educators and policy makers, thus contributing to support the implementation of practices that promote sleep quality, napping until later in life as well as to promote the health of future adults.

Study Overview

• Status: Recruiting
• Conditions: Sleep
• Intervention / Treatment: Other: Actigraphy; Other: Schedule of Growing Skills II; Other: Questionnaire Children Sleep habits; Other: Melatonin evaluation

• Study Type: Observational
• Enrollment (Estimated): 119

Contacts and Locations

• Study Contact: Name: Janete Santos, PhD; Phone Number: (+351) 225 513 600; Email: investigaclinica@med.up.pt
• Study Contact Backup: Name: Andreia Neves, PhDc; Phone Number: (+351) 225513624; Email: andreia.sobrinho.neves@gmail.com

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Recruiting
    • Faculty of Medicine (FMUP)
    • Contact: Elisa Keating, PhD; Phone Number: (+351) 225513624; Email: keating@med.up.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study population will be healthy children aged 2 to 4 years old. Considering that the most prevalent differences in Growing Skills II scale scores will be around 3 and 5 points for a healthy toddler population as ours and that we will need to divide the population into 3 groups of sleep patterns (seriously sleep-restricted, moderately sleep-restricted and normal sleepers),

Description

Inclusion Criteria:

• Children aged 2 and 6 months year until the first assessment;
• Gestational age at birth 37 weeks or more;
• Delivery without serious complications for the child;
• Absence of developmental pathologies or pathologies that interfere with psychic and motor development;

Exclusion Criteria:

• Non-preterm birth but with severe growth restriction;
• Diagnosis of psychomotor development pathology;
• Diagnosis of pathology that interferes with psychomotor development;
• Taking daily medication, except vitamin supplements.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Healthy children; Aged 2 to 4 years old

Other: Actigraphy; Actigraphy is a validated complementary means of diagnosis, the gold standard for the assessment of circadian rhythm.; Other: Schedule of Growing Skills II; Assessment scale for skills in child development from 0 to 6 years.; Other: Questionnaire Children Sleep habits; Questionnaire for assessing sleep habits, validated for the Portuguese population (4) which allows us to understand the sleep hygiene habits of the child; Other: Melatonin evaluation; Melatonin will be measured in the first-morning urine and it is considered to be a good marker of plasma MLT level since its concentration is highly correlated with nocturnal plasma melatonin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep patterns	Sleep patterns based on movement tracking by sleep actigraphy.	At 24 - 30 months of age, at 3 years of age and at 4 years of age
Psychomotor development	The psychomotor developmental coefficient obtained through the application of the evaluation tool Schedule of growing skills II (SGS II) development scale.	At 24 - 30 months of age, at 3 years of age and at 4 years of age
Sleep hygiene	Sleep hygiene data obtained through the application of the Children Sleep habits questionnaire validated for the Portuguese population.	At 24 - 30 months of age, at 3 years of age and at 4 years of age
Melatonin levels	Levels of 6-sulphatoxymelatonin-aMT6, melatonin metabolite, measured in urine.	At 24 - 30 months of age, at 3 years of age and at 4 years of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index [BMI]	Weight [kg, kilogram] and height [m, meter] at the date of the evaluation for BMI-for-age calculation	At 24 - 30 months of age, at 3 years of age and at 4 years of age
Number of infectious events	Number of infectious events in the first year of life and previous year of the following assessments.	At 24 - 30 months of age, at 3 years of age and at 4 years of age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics and lifestyle habits of the parents and family	Questionnaire about demographic parameters and lifestyle of the parents and family: Age group (less than 24 years; 24-29; 30-35; 35-40; more than 40); Household; Level of education; Profession; Shift work; Smoking habits; Diet (omnivore, vegetarian, ovolactovegetarian, vegan or other); Average bedtime; Average total sleeping time; Sleep schedules between weekdays and the weekend; Chronotype; History of sleep disturbances; Vitamin supplementation during pregnancy; History of postpartum depression.	At 24 - 30 months of age
Medical history and biometrics of the child	Questionnaire about the medical history and biometrics of the child: Gestational age at birth; APGAR index; Weight [kg, kilogram], length [meter, m] and head circumference [centimeter, cm] at birth; Type of feeding (breast milk, adapted milk or mixed feeding); Daycare attendance.	At 24 - 30 months of age

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Centro Hospitalar De São João, E.P.E.; Centro de Investigação em Tecnologias e Serviços de Saúde; Rede de Investigação em Saúde; Up2Kids Pediatric Center - Vila Nova de Gaia; USF Saúde no Futuro - Vila Nova de Gaia
• Investigators: Principal Investigator: Elisa Keating, PhD, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: melatonin; actigraphy; psychomotor development; childhood,
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antioxidants; Protective Agents; Melatonin
• Other Study ID Numbers: SleePsy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No