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

描述（由申请人提供）：本研究的目的是确定一种有效客观的方法来诊断老年痴呆症患者普遍存在的睡眠障碍，不宁腿综合征（RLS）。RLS的特点是腿部感觉不舒服，干扰睡眠，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，这使他们无法报告感觉症状，并且没有有效的客观措施可以诊断他们的RLS。这种症状很可能出现在老年痴呆症患者身上，因为他们通常有缺铁和服用多巴胺拮抗剂等RLS风险因素。腿部运动等运动活动、腿部不适的迹象（如摩擦腿部）和缺铁都可能是RLS的症状。美国国立卫生研究院会议建议在老年痴呆症患者中测试这些RLS客观指标的有效性。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测量方法，即行为指标测试-不宁腿（BIT-RL）。一项前期研究表明，老年RLS患者和老年痴呆患者在BIT-RL上的RLS行为指标出现频率较高。我们还在102名老年痴呆症患者中发现，腿部运动增加预示着老年痴呆症患者夜间睡眠减少，这表明腿部运动可能是RLS的一个标志。在本研究中，我们的目的是确定BIT-RL的敏感性、特异性和临界值（仪器评分表明阳性诊断）；测量腿部运动的仪器——周期性活动监测仪（rl）；血清铁蛋白。我们将在没有痴呆症的老年人中进行这项研究，因为他们可以用语言描述他们的RLS症状，而自我报告症状是诊断的“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）将在普通临床研究中心度过3天3夜。盲法研究助理将使用BIT-RL和一晚的多导睡眠描记仪来观察睡眠呼吸暂停症的行为。GCRC的工作人员将收集血清铁蛋白。参与者将佩戴定期活动监视器（rl） 5晚。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访谈，并对RLS阳性或阴性进行诊断。接收机操作者曲线将决定诊断RLS的最佳单一或组合仪器。

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.