Association Between Sleep and Psychomotor Development in Early Childhood

NCT06816225 | Recruiting

• 1 other identifier: SleePsy
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep

Keywords

childhood,; psychomotor development; melatonin; actigraphy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Body Mass Index [BMI]

  At 24 - 30 months of age, at 3 years of age and at 4 years of age

• Number of infectious events

  At 24 - 30 months of age, at 3 years of age and at 4 years of age

Other Outcomes (2)

• Demographics and lifestyle habits of the parents and family

  At 24 - 30 months of age

• Medical history and biometrics of the child

  At 24 - 30 months of age

Study Arms (1)

Healthy children

Aged 2 to 4 years old

Other: Actigraphy; Other: Schedule of Growing Skills II; Other: Questionnaire Children Sleep habits; Other: Melatonin evaluation

Interventions

Actigraphy OTHER

Actigraphy is a validated complementary means of diagnosis, the gold standard for the assessment of circadian rhythm.

Healthy children

Schedule of Growing Skills II OTHER

Assessment scale for skills in child development from 0 to 6 years.

Healthy children

Questionnaire Children Sleep habits OTHER

Questionnaire for assessing sleep habits, validated for the Portuguese population (4) which allows us to understand the sleep hygiene habits of the child

Healthy children

Melatonin evaluation OTHER

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.

Healthy children

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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),

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro Hospitalar De São João, E.P.E.: collaborator
• Centro de Investigação em Tecnologias e Serviços de Saúde: collaborator
• Rede de Investigação em Saúde: collaborator
• Up2Kids Pediatric Center - Vila Nova de Gaia: collaborator
• USF Saúde no Futuro - Vila Nova de Gaia: collaborator

Study Sites (1)

Faculty of Medicine (FMUP)

Porto, 4200-319, Portugal

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Interventions

Actigraphy

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques

Study Officials

• Elisa Keating, PhD

  faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreia Neves, PhDc

CONTACT

(+351) 225513624; andreia.sobrinho.neves@gmail.com

Janete Santos, PhD

CONTACT

(+351) 225 513 600; investigaclinica@med.up.pt

Study Design

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

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: February 10, 2025
• Study Start: June 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: December 1, 2025
• Last Updated: February 10, 2025

Record last verified: 2024-09

Locations

PT (1)