Association Between Sleep and Psychomotor Development in Early Childhood

Recruiting

• Conditions: Sleep

• Registration Number: NCT06816225
• Lead Sponsor: Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Primary Completion: 2025-01-31
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 119

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine (FMUP); 🇵🇹 Porto, Portugal