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Association Between Sleep and Psychomotor Development in Early Childhood

Association Between Sleep and Psychomotor Development in Early Childhood

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06816225
Acronym
SleePsy
Enrollment
119
Registered
2025-02-10
Start date
2023-06-01
Completion date
2025-12-01
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

childhood,, psychomotor development, melatonin, actigraphy

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.

Interventions

OTHERActigraphy

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

OTHERSchedule of Growing Skills II

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

OTHERQuestionnaire 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

OTHERMelatonin 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.

Sponsors

Centro Hospitalar De São João, E.P.E.
CollaboratorOTHER
Centro de Investigação em Tecnologias e Serviços de Saúde
CollaboratorOTHER
Rede de Investigação em Saúde
CollaboratorOTHER
Up2Kids Pediatric Center - Vila Nova de Gaia
CollaboratorUNKNOWN
USF Saúde no Futuro - Vila Nova de Gaia
CollaboratorUNKNOWN
Universidade do Porto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 4 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Melatonin levelsAt 24 - 30 months of age, at 3 years of age and at 4 years of ageLevels of 6-sulphatoxymelatonin-aMT6, melatonin metabolite, measured in urine.
Sleep patternsAt 24 - 30 months of age, at 3 years of age and at 4 years of ageSleep patterns based on movement tracking by sleep actigraphy.
Psychomotor developmentAt 24 - 30 months of age, at 3 years of age and at 4 years of ageThe psychomotor developmental coefficient obtained through the application of the evaluation tool Schedule of growing skills II (SGS II) development scale.
Sleep hygieneAt 24 - 30 months of age, at 3 years of age and at 4 years of ageSleep hygiene data obtained through the application of the Children Sleep habits questionnaire validated for the Portuguese population.

Secondary

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

Other

MeasureTime frameDescription
Demographics and lifestyle habits of the parents and familyAt 24 - 30 months of ageQuestionnaire 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.
Medical history and biometrics of the childAt 24 - 30 months of ageQuestionnaire 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.

Countries

Portugal

Contacts

Primary ContactAndreia Neves, PhDc
andreia.sobrinho.neves@gmail.com(+351) 225513624
Backup ContactJanete Santos, PhD
investigaclinica@med.up.pt(+351) 225 513 600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026