SleepSleePsyNCT06816225
Association Between Sleep and Psychomotor Development in Early Childhood
An observational study of Sleep, run by Universidade do Porto at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Actigraphy, Schedule of Growing Skills II and Questionnaire Children Sleep habits
- How many people
- 119 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2023to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
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),
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Medicine (FMUP)
Porto, 4200-319
Elisa Keating, PhD, (+351) 225513624, keating@med.up.pt
About this study
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
- Being tested
- Actigraphy, Schedule of Growing Skills II, Questionnaire Children Sleep habits, Melatonin evaluation
- Keywords
- childhood,, psychomotor development, melatonin, actigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphyOther
Actigraphy is a validated complementary means of diagnosis, the gold standard for the assessment of circadian rhythm.
Schedule of Growing Skills IIOther
Assessment scale for skills in child development from 0 to 6 years.
Questionnaire Children Sleep habitsOther
Questionnaire for assessing sleep habits, validated for the Portuguese population (4) which allows us to understand the sleep hygiene habits of the child
Melatonin evaluationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy children | Aged 2 to 4 years old Receives: Other: Actigraphy; Other: Schedule of Growing Skills II; Other: Questionnaire Children Sleep habits; Other: Melatonin evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep patterns
Sleep patterns based on movement tracking by sleep actigraphy.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 24 - 30 months of age, at 3 years of age and at 4 years of age
Secondary outcomes (2)
Body Mass Index [BMI]
Weight [kg, kilogram] and height [m, meter] at the date of the evaluation for BMI-for-age calculation
Measured: 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.
Measured: At 24 - 30 months of age, at 3 years of age and at 4 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Jun 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Elisa Keating, PhD, Principal investigator, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816225
- Sponsor's protocol ID
- SleePsy
- Acronym
- SleePsy
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Sleep and Psychomotor Development in Early Childhood
- ClinicalTrials.gov ID
- NCT06816225
- Acronym / sponsor ID
- SleePsy / SleePsy
- Conditions
- Sleep
- Keywords
- childhood,, psychomotor development, melatonin, actigraphy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- 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
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy children | – | Other: Actigraphy, Other: Schedule of Growing Skills II, Other: Questionnaire Children Sleep habits, Other: Melatonin evaluationAged 2 to 4 years old |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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),
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActigraphyActigraphy is a validated complementary means of diagnosis, the gold standard for the assessment of circadian rhythm. | Other | Healthy children |
| Schedule of Growing Skills IIAssessment scale for skills in child development from 0 to 6 years. | Other | Healthy children |
| Questionnaire Children Sleep habitsQuestionnaire for assessing sleep habits, validated for the Portuguese population (4) which allows us to understand the sleep hygiene habits of the child | Other | Healthy children |
| Melatonin evaluationMelatonin 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. | Other | Healthy children |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Body Mass Index [BMI]
Time frame: At 24 - 30 months of age, at 3 years of age and at 4 years of age
Number of infectious events
Time frame: At 24 - 30 months of age, at 3 years of age and at 4 years of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Keating, PhD principal investigator
faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreia Neves, PhDc ((+351) 225513624, andreia.sobrinho.neves@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep patterns (time frame: At 24 - 30 months of age, at 3 years of age and at 4 years of age). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.