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临床试验/NCT00060723
NCT00060723已完成不适用

Behavioral Effect of Obstructive Sleep Apnea in Children

University of Michigan1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 1999年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
1

研究概览

简要总结

Sleep-disordered breathing (SDB) in children may be responsible for disruptive daytime behaviors such as inattention and hyperactivity. Many children undergo tonsillectomy for SDB and disruptive daytime behaviors. However, the link between SDB and disruptive behavior is not clearly understood. This study will evaluate the relationship between SDB and disruptive behavior.

详细描述

While adenotonsillectomy (AT) remains one of the most common surgical procedures performed in children, indications for AT have changed in recent years. Surgeons now perform AT for suspected obstructive SDB and for daytime behaviors that may be a consequence of SDB, such as inattention and hyperactivity. However, whether SDB causes these and other disruptive behaviors is not well known. Further, the precise nature of these behaviors and what types or levels of SDB may be of concern are poorly understood. Consequently, pediatricians and otolaryngologists are not able to use objective preoperative testing to assess SDB and abnormal behavior.

This research project seeks to better define the relationship between childhood SDB and daytime behavioral problems and to determine whether SDB actually causes these behaviors. The study will better define whether inattention and hyperactivity are frequent among children who undergo AT, will identify measures and levels of SDB that are indicative of these behaviors, and will test whether improvement in SDB after AT is associated with improvement in behavior.

Five- to twelve-year-old children who have been scheduled for AT or for a control group procedure (minimally invasive, non-airway-related surgeries such as herniorraphies) will undergo behavioral assessments, cognitive tests, and structured psychiatric interviews. A secondary control group will include healthy children who are not scheduled for any type of surgery. Preoperative assessments will be used to define what behaviors are more prominent in the children scheduled for AT than in children scheduled for hernia repair. All children will undergo preoperative polysomnography to detect subtle forms of SDB that may be particularly prevalent in children. Children will also undergo assessments after surgery.

Children will be scheduled for two or three study visits, depending on whether participants agreed to an optional 3-month interim assessment. Children will be followed for approximately 1 year from the date of surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • 未提供

排除标准

  • 未提供

研究者

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

Ronald D. Chervin, M.D., M.S.

Michael S Aldrich Collegiate Professor of Sleep Medicine and Professor of Neurology

University of Michigan

研究点 (1)

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