Biomarkers of Insomnia and Fatigue in HIV/AIDS

描述（由申请人提供）： 这项拟议研究的目的是描述HIV感染者失眠亚型（起始、维持和白天疲劳或嗜睡）的经历，并确定与这些亚型相关的生物标志物，以便开发和测试更具针对性的干预措施，以改善睡眠，减少疲劳，从而提高HIV血清阳性男性和女性的生活质量。 在I期，将在01-02年收集250名或更多受试者的横断面样本的描述性数据，以确定失眠亚型与选定生物标志物之间的关系。 在II期研究中，将收集最多100名男性和100名女性的纵向数据，在时间1时无症状，以表征失眠亚型随时间的发展。 有四个目标：1）客观睡眠障碍之间的关系（觉醒/睡眠节律、昼夜总睡眠时间、入睡后觉醒）和常见基因多态性、选定代谢参数（胰岛素、葡萄糖、脂联素、瘦素、游离脂肪酸）、HIV严重程度指标（病毒载量、CD 4细胞计数）、脂肪代谢障碍的人体测量和生活质量（疲劳，认知功能，抑郁症状）为男性和女性谁是艾滋病毒血清阳性; 2）测试主观睡眠障碍之间的关系（入睡时间、醒来次数）和基因多态性、代谢参数、艾滋病毒指标、人体测量学和男女的生活质量; 3）描述HIV-血清阳性的最初无症状受试者随时间的症状发作和药物依从性;和4）测试在目标1和目标2中显著的变量集合最佳预测失眠亚型的发作。 据推测，一组生物标志物，最好的预测开始失眠的发作可能不同于预测维持性失眠或日间生活质量的措施的变量。

DESCRIPTION (provided by applicant): The purpose of this proposed study is to characterize the experience of subtypes of insomnia (initiation, maintenance, and daytime fatigue or sleepiness) in HIV-infected persons, and to identify biomarkers associated with these subtypes such that a more targeted intervention can be developed and tested to improve sleep, reduce fatigue, and thereby enhance quality of life in HIV-seropositive men and women. In Phase I, descriptive data will be gathered on a cross-sectional sample of 250 or more subjects in year 01-02 to identify relationships between insomnia subtypes and selected biomarkers. In Phase II, longitudinal data will be gathered on up to 100 men and 100 women, asymptomatic at Time 1, to characterize insomnia subtypes as they develop over time. There are four aims: 1) test relationships between objective sleep disturbance (wake/sleep rhythm, total sleep time day and night, wake after sleep onset) and common gene polymorphisms, selected metabolic parameters (insulin, glucose, adiponectin, leptin, free fatty acids), HIV severity indicators (viral load, CD4 cell count), anthropometric measures of lipodystrophy, and quality of life (fatigue, cognitive function, depressive symptoms) for both men and women who are HIV-seropositive; 2) test relationships between subjective sleep disturbances (time to fall asleep, awakenings) and gene polymorphisms, metabolic parameters, HIV indicators, anthropometrics, and quality of life for both men and women; 3) describe onset of symptoms and medication adherence over time in initially asymptomatic subjects who are HIV-seropositive; and 4) test which sets of variables significant in Aim 1 and Aim 2 best predict the onset of insomnia subtypes. It is hypothesized that the set of biomarkers that best predict the onset of initiation insomnia may differ from the variables that predict maintenance insomnia or daytime quality of life measures.