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临床试验/NCT00253695
NCT00253695已完成不适用

Sleep Studies in HIV+ Older Children/Adolescents

Baylor College of Medicine1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2004年7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
90
试验地点
1
主要终点
Association of cytokines, sleep patterns, and neurocognitive function in youth with HIV.

研究概览

简要总结

This study is a first step in approaching the gap existing between understanding sleep abnormalities, alterations in sleep-regulating cytokines and HIV-1 disease regulating cytokines, and abnormal higher cortical function.

详细描述

BACKGROUND:

In the growing number of HIV infected youth and young adults, it is important to study the effects of HAART treatment on sleep patterns and related neurocognitive and psychosocial function.

DESIGN NARRATIVE (including primary and secondary outcomes):

Using validated sleep questionnaires and actigraphy measurements, overnight polysomnography (PSG, sleep study) will assess the degree of abnormal sleeping patterns and daytime sleepiness in HIV infected children and HIV uninfected children (control group).

The following peripheral blood levels will be measured over a 24-hour period, at multiple time points, in all participants: TNF-alphaRI and IL-6 (sleep-regulating cytokines); IFN-gamma and IL-12 (cytotoxic or TH1 cytokines); and IL-10 and IL-1RA (inflammatory or TH2 cytokines). This will help to determine the association between alterations in sleep-regulating cytokines and HIV disease progression (CD4+ T-cell count, HIV-1 RNA level).

研究设计

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

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • HIV-1 infection
  • Control Group
  • Family members and friends of HIV-1 infected children

排除标准

  • Pregnancy
  • Control Group
  • Pregnancy
  • Sleep apnea

结局指标

主要结局

Association of cytokines, sleep patterns, and neurocognitive function in youth with HIV.

时间窗: 11/2005 - 02/2009

Observational study only

次要结局

未报告次要终点

研究者

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

William Shearer

Professor

Baylor College of Medicine

研究点 (1)

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