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临床试验/NCT01434082
NCT01434082Unknown不适用

Sleep Patterns in Children With and Without Juvenile Idiopathic Arthritis

University of Washington1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Prevalence of Sleep Disordered Breathing

研究概览

简要总结

The investigators are doing this study to look at sleep problems, daytime sleepiness, and thinking and behavior patterns in children with arthritis and in children without arthritis. Arthritis is a problem with joints. Some children have arthritis and some children do not have arthritis.

Sleep disordered breathing is a sleeping problem in which some children snore and have pauses in their breathing during sleep. It is associated with not enough or fragmented sleep, poor school performance, problems paying attention, and behavior problems.

The investigators do not know how many children with arthritis have sleep problems, and how it is linked to daytime sleepiness and children's learning, and behavior patterns compared to children without arthritis. The investigators need to study both children with arthritis and children without arthritis to learn more about these connections and to understand if they are the same or different in children with arthritis and in children without arthritis.

详细描述

Overview of Study:

  • Children and their parent will be scheduled to come to the University of Washington School of Nursing Sleep Laboratory for overnight polysomnography, and to complete multi-sleep latency tests and a battery of neurobehavioral performance tests the next day at a convenient time and day.
  • Children will be asked to complete a sleep, symptoms (pain, fatigue), behavior, and day to day activity surveys, and the parent who accompanies the child to the laboratory, will be asked to complete surveys assessing demographics, child's usual sleep, behavior, school performance, health status, and family functioning.
  • Children will also be asked to spit in a container and urinate in a container upon awakening in the morning after their sleep study.

Primary Aims of the Study:

  1. Compare indices of sleep disturbances, risk factors, and type of sleep disordered breathing(primary snoring, upper airway resistance syndrome, obstructive sleep apnea) in Juvenile Idiopathic Arthritis (JIA) to age, sex matched control children.
  2. Compare scores on neurobehavioral tests and daytime sleepiness; and to describe associations between indices of sleep disturbances on neurobehavioral performance and daytime sleepiness in JIA to age, sex matched control children.

Secondary Objectives:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with and without arthritis, 6 thru 11 years old, able to speak English
  • Children with JIA not recently hospitalized for severe JIA.
  • Subject's parents or legal guardian are > 18 years of age and able to read and speak English.
  • Subject's parent or legal guardian has provided written informed consent prior to screening for this study.

排除标准

  • A child with a history of/current diagnosis of a psychiatric condition meeting DSM-IV-TR (e.g. depression, bipolar disorder) that would interfere with ability to comply with protocol requirements, or give informed consent, or be expected to have disordered sleep.
  • A child with acute illness such as a cold or the flu that would interfere with sleep and neurobehavioral testing.
  • A chronic condition such as cancer, diabetes, or asthma which would, in the investigator's opinion, compromise the subject's ability to comply with the study requirements and interfere with ability to comply with protocol requirements.
  • Children admitted to the hospital for severe JIA within the last 2 months.
  • Children with a BMI >95th percentile (defined as obesity by CDC) will be excluded because of potential impact of obesity on SDB.
  • A parent or legal guardian with a chronic condition that would compromise the parent's ability to comply with protocol requirements.

结局指标

主要结局

Prevalence of Sleep Disordered Breathing

时间窗: 3.5 years

次要结局

  • Measures of Daytime Sleepiness(3.5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Teresa Ward

Assistant Professor, Prinicpal Investigator

University of Washington

研究点 (1)

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