Validation of Measures of Restless Legs Syndrome for Elders with Memory Disorders

描述(申请人提供)：这项研究的目的是确定一种有效的客观方法来诊断老年痴呆症患者中普遍存在的睡眠障碍-不宁腿综合征(RLS)。RLS的特点是腿部不适，扰乱睡眠，并与健康和认知功能显著下降有关。患有痴呆症的老年人有认知和语言缺陷，使他们无法报告感觉症状，而且没有有效的客观措施可以诊断他们的RLS。这种综合征很可能出现在患有痴呆症的老年人中，因为他们通常有RLS的危险因素，如缺铁和服用多巴胺拮抗剂。腿部活动等运动、腿部摩擦等腿部不适症状以及缺铁可能预示着RLS。NIH的一次会议建议测试这些RLS客观指标在患有痴呆症的老年人中的有效性。我们的研究团队利用NIH的建议和我们之前的仪器开发经验开发了一种观察性RLS测量工具，即行为指标测试-不安宁腿(BIT-RL)。一项初步研究表明，患有RLS的老年人和痴呆症老年人在BIT-RL上出现RLS行为指标的频率较高。我们还在102名痴呆症老年人中表明，腿部活动增加预示着痴呆症老年人夜间睡眠减少，这表明腿部运动可能是RLS的一个标志。在这项研究中，我们的目标是确定BIT-RL、腿部运动-周期性活动监测器-RL和血清铁蛋白的敏感性、特异性和临界值(仪器上表明阳性诊断的分数)。我们将在没有痴呆症的老年人中进行这项研究，因为他们可以用言语表达他们的RLS症状，而症状的自我报告是诊断的“金标准”。符合RLS诊断标准的参与者(n=186)和不符合RLS诊断标准的参与者(n=186)将在综合临床研究中心度过3个昼夜。盲人研究助理将使用BIT-RL和一晚的多导睡眠图对RLS行为进行观察，以筛查睡眠呼吸暂停。GCRC的工作人员将收集血清铁蛋白。参赛者将佩戴定期活动监测器-RL 5晚。一名训练有素的执业护士将对RLS症状进行约翰霍普金斯结构化诊断面谈，并做出RLS阳性或RLS阴性的诊断。接收器操作员曲线将确定诊断RLS的最佳单一仪器或仪器组合。

DESCRIPTION (provided by applicant): The purpose of this research is to identify a valid objective method to diagnose a prevalent sleep disorder, restless legs syndrome (RLS), in elders with dementia. RLS is characterized by uncomfortable leg sensations that disturb sleep and are associated with significantly decreased health and cognitive functioning. Elders with dementia have cognitive and language deficits that prevent them from reporting sensory symptoms, and there are no valid objective measures that can diagnose RLS in them. The syndrome is likely to be present in elders with dementia because they often have RLS risk factors like iron deficiency and taking dopamine antagonists. Motor activity such as leg movement, signs of leg discomfort such as rubbing the legs, and iron deficiency may indicate RLS. An NIH conference recommended testing the validity of these RLS objective indicators in elders with dementia. Our research team used the NIH recommendations and our prior instrument development experience to develop an observational RLS measure, the Behavioral Indicators Test-Restless Legs (BIT-RL). A pilot study showed that elders with RLS and elders with dementia have high frequencies of RLS behavioral indicators on the BIT-RL. We also have shown in 102 elders with dementia that increased leg movements are predictive of reduced sleep at night in elders with dementia, indicating that leg movements may be a marker for RLS. In this study, we aim to determine the sensitivity, specificity, and cut-off values (scores on the instruments that indicate a positive diagnosis) for the BIT-RL; a measure of leg movements - the Periodic Activity Monitor-RL; and serum ferritin. We will conduct the study in elders without dementia because they can verbalize their RLS symptoms, and self-report of symptoms is the diagnostic "gold standard". Participants (n=186) who meet the RLS diagnostic criteria and those (n=186) who do not will spend 3 days and nights at the General Clinical Research Center. Blinded research assistants will conduct observations for RLS behaviors using the BIT-RL and one night of polysomnography to screen for sleep apnea. Staff at the GCRC will collect serum ferritin. Participants will wear the Periodic Activity Monitor-RL for 5 nights. A trained nurse practitioner will conduct the Johns Hopkins Structured Diagnostic Interview of RLS Symptoms and make the diagnosis of RLS positive or RLS negative. Receiver Operator Curves will determine the best single or combination of instruments to diagnose RLS.