Biomarkers of Insomnia and Fatigue in HIV/AIDS

描述(由申请人提供)： 这项拟议的研究的目的是描述HIV感染者的失眠亚型(初始、维持和日间疲劳或嗜睡)的经历，并确定与这些亚型相关的生物标志物，以便开发和测试更有针对性的干预措施，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。在第一阶段，将在01-02年度收集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。在第二阶段，将收集多达100名男性和100名女性的纵向数据，在时间1没有症状，以确定失眠亚型随着时间的推移而发展的特征。研究的目的有四个：1)测试客观睡眠障碍(觉醒/睡眠节律、昼夜总睡眠时间、入睡后醒来)与常见基因多态性、选定的代谢参数(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、CD4细胞计数)、脂肪营养不良的人体测量指标以及HIV血清阳性男女的生活质量(疲劳、认知功能、抑郁症状)之间的关系；2)测试主观睡眠障碍(入睡时间、觉醒时间)与基因多态性、代谢参数、HIV指标、人体测量学以及男女生活质量之间的关系；3)描述最初无症状的HIV血清阳性受试者的症状的出现和随时间的药物依从性；以及4)测试在目标1和目标2中有意义的变量集最能预测失眠亚型的发生。假设最能预测发作性失眠发病的生物标记物可能与预测维持性失眠或日间生活质量测量的变量不同。

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.