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Идёт набор NCT06787378

The Sweet Dreams Study - Accuracy of Sleep Trackers in Children

— 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Sleep. Базовые параметры: 2 лет — 17 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The study aims to evaluate the accuracy of sleep trackers in children aged 2 to less than 18 years. Children undergoing polysomnography, the gold standard for assessing sleep quality and duration, at Arkansas Children's Hospital may be eligible to participate. Participants will be asked to wear sleep trackers on the day of their sleep test. The data collected from the sleep trackers will be compared with the polysomnography results to determine the devices' accuracy.

Подробное описание

Participants will meet the research team at Arkansas Children's Hospital (ACH) two to three hours before their scheduled sleep test and are required to bring a stool sample from the child to the visit.

During the visit, the research team will gather information about the child's home environment and medical history, including parent marital status, parental education level, household income, and other factors. Questionnaires will also cover topics such as the child's growth and development, diet, physical activity, use of substances like tobacco and alcohol, and mood. Any questions that cause discomfort may be skipped by the child or their parent.

A brief physical exam will be conducted to measure the child's weight, height, blood pressure, and heart rate. Sleep trackers will then be programmed and placed, with two worn on the wrist and two around the waist. Instructions on how to remove and reattach the trackers will be provided to ensure proper use.

After completing the sleep test at ACH, the sleep trackers must be left in the sleep clinic. All four trackers must be returned, and parents will be asked to report if the trackers were removed at any point during the study.

Первичные конечные точки

  • Total sleep time [Срок оценки: Up to 10 days after consent]
  • Wake after sleep onset [Срок оценки: Up to 10 days after consent]
  • Sleep efficiency [Срок оценки: Up to 10 days after consent]

Критерии участия

Критерии включения

  • Age 2 to <18 years
  • All BMIs
  • Scheduled at PSDC for evaluation of obstructive sleep apnea, snoring, or noisy breathing during sleep.

Критерии исключения

  • Known diagnosis of sleep disorder
  • Neurological disorders (e.g., epilepsy, cerebral palsy, etc.)
  • Autism spectrum disorder
  • Attention deficit hyperactivity disorder
  • Oppositional defiant disorder
  • Chronic kidney disease
  • Hormonal disease
  • Autoimmune diseases
  • Bleeding disorders
  • Chronic infections (e.g., HIV, hepatitis B)
  • Mental health disorders (e.g., depression, anxiety)
  • Liver disease (e.g. hepatitis)
  • Referral for evaluation of disorders other than obstructive sleep apnea, snoring, or noisy breathing during sleep.
  • Pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest.
  • Refusal to authorize study investigators to access data from the polysomnography test conducted at the Arkansas Children's Hospital PSDC.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 2 центра
  • Arkansas Children's Hospital — Little Rock
  • Arkansas Children's Nutrition Center — Little Rock

Публикации

  • Lu MJ, Zhong WH, Liu YX, Miao HZ, Li YC, Ji MH. Sample Size for Assessing Agreement between Two Methods of Measurement by Bland-Altman Method. Int J Biostat. 2016 Nov 1;12(2):/j/ijb.2016.12.issue-2/ijb-2015-0039/ijb-2015-0039.xml. doi: 10.1515/ijb-2015-0039. PMID 27838682
  • Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. PMID 2868172
  • Smith C, Galland B, Taylor R, Meredith-Jones K. ActiGraph GT3X+ and Actical Wrist and Hip Worn Accelerometers for Sleep and Wake Indices in Young Children Using an Automated Algorithm: Validation With Polysomnography. Front Psychiatry. 2020 Jan 14;10:958. doi: 10.3389/fpsyt.2019.00958. eCollection 2019. PMID 31992999
  • Quante M, Kaplan ER, Cailler M, Rueschman M, Wang R, Weng J, Taveras EM, Redline S. Actigraphy-based sleep estimation in adolescents and adults: a comparison with polysomnography using two scoring algorithms. Nat Sci Sleep. 2018 Jan 18;10:13-20. doi: 10.2147/NSS.S151085. eCollection 2018. PMID 29403321

Идентификаторы

NCT: NCT06787378 · 275668

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗