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NCT Number: NCT06816225

Association Between Sleep and Psychomotor Development in Early Childhood

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.

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Key information

Conditions

Sleep

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine (FMUP)

Porto, 4200-319, Portugal

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Actigraphy

Other

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

Schedule of Growing Skills II

Other

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

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

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.

Primary outcomes

  1. Sleep patterns

    Time frame: 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.

  2. Psychomotor development

    Time frame: 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.

  3. Sleep hygiene

    Time frame: 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.

  4. Melatonin levels

    Time frame: 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 outcomes

  1. Body Mass Index [BMI]

    Time frame: 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

  2. Number of infectious events

    Time frame: 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.

Other outcomes

  1. Demographics and lifestyle habits of the parents and family

    Time frame: At 24 - 30 months of age

    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.

  2. Medical history and biometrics of the child

    Time frame: At 24 - 30 months of age

    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.

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

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

Registry information

Acronym: SleePsy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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