Biomarkers of Insomnia and Fatigue in HIV/AIDS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to identify biological markers, including genes, associated with sleep disturbance and other symptoms among people with HIV.
详细描述
This study will characterize insomnia subtypes and identify genetic markers and metabolic parameters associated with these subtypes. The results will be useful in later developing interventions to improve sleep, reduce fatigue, and thereby enhance the quality of life of HIV-infected persons.
A cross-sectional sample of 350 subjects will be recruited to describe relationships between biomarkers and insomnia subtypes. The initial assessment will include:
- wearing a wrist actigraph for 72 hours
- providing a fasting blood sample
- measuring blood pressure, height, weight, neck, waist, hip, and thigh
- completing questionnaires
- urine screening
Depending on the results of the initial assessment, approximately 200 subjects will be followed every month by telephone to assess symptoms and every 3 to 6 months with study visits similar to the initial assessment. Findings from this longitudinal part of the study will characterize the development of insomnia, fatigue, and daytime sleepiness over time in patients living with HIV.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infection
- •Access to a telephone
- •Able to read and write English
排除标准
- •Current use of illicit drugs
- •Currently pregnant or within the previous 3 months
- •Working nightshift
- •Diagnosis of sleep apnea, narcolepsy, restless legs syndrome, or periodic limb movements, dementia, or psychotic illness