Sleep Studies in HIV+ Older Children/Adolescents
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
- 是
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
William Shearer
Professor
Baylor College of Medicine
