Меню
Идёт набор NCT06816225

Association Between Sleep and Psychomotor Development in Early Childhood

Наблюдательное Sleep

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Actigraphy, Schedule of Growing Skills II, Questionnaire Children Sleep habits, Melatonin evaluation.
Кому может быть актуально
Состояния в реестре: Sleep. Базовые параметры: 2 лет — 4 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Португалия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Вмешательства

  • Другое Actigraphy
    Actigraphy is a validated complementary means of diagnosis, the gold standard for the assessment of circadian rhythm.
  • Другое Schedule of Growing Skills II
    Assessment scale for skills in child development from 0 to 6 years.
  • Другое Questionnaire 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
  • Другое Melatonin 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.

Первичные конечные точки

  • Sleep patterns [Срок оценки: At 24 - 30 months of age, at 3 years of age and at 4 years of age]
  • Psychomotor development [Срок оценки: At 24 - 30 months of age, at 3 years of age and at 4 years of age]
  • Sleep hygiene [Срок оценки: At 24 - 30 months of age, at 3 years of age and at 4 years of age]
  • Melatonin levels [Срок оценки: At 24 - 30 months of age, at 3 years of age and at 4 years of age]
Вторичные конечные точки (2)
  • Body Mass Index [BMI] [Срок оценки: At 24 - 30 months of age, at 3 years of age and at 4 years of age]
  • Number of infectious events [Срок оценки: At 24 - 30 months of age, at 3 years of age and at 4 years of age]

Критерии участия

Критерии включения

  • 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;

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Португалия · 1 центр
  • Faculty of Medicine (FMUP) — Porto

Идентификаторы

NCT: NCT06816225 · SleePsy

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗