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

针对患有记忆障碍的老年人的不宁腿综合症措施的验证

• 批准号: 7258040
• 负责人: Kathy Culpepper Richards
• 金额: $ 47.76万
• 依托单位: POLISHER RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-15 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7258040
• 关键词: Behavior; Behavioral; Blinded; Caregiver Burden; Caregivers; Clinical Research; Cognition; Cognitive; Data; Dementia; Device or Instrument Development; Diagnosis; Diagnostic; Disease; Dopamine Agonists; Dopamine Antagonists; Elderly; Esthesia; Exhibits; Ferritin; Frequencies; Goals; Gold; Hand; Health; Health Status; Institutionalization; Interview; Iron; Language Disorders; Leg; Light; Measurement; Measures; Memory Disorders; Methods; Monitor; Motor Activity; Movement; Numbers; Nurse Practitioners; Participant; Patient Self-Report; Persons; Pilot Projects; Polysomnography; Population; Purpose; Quality of life; Recommendation; Replacement Therapy; Reporting; Research; Restless Legs Syndrome; Risk Factors; Sampling; Score; Sensitivity and Specificity; Sensory; Serum; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Sleep disturbances; Societies; Somnambulism; Standards of Weights and Measures; Structure; Symptoms; Syndrome; Testing; Training; United States National Institutes of Health; Validation; behavior measurement; cognitive function; day; diagnostic accuracy; experience; falls; improved; indexing; instrument; prevent; programs; symposium; validation studies

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.

描述（由申请人提供）：本研究的目的是确定一种有效的客观方法来诊断患有痴呆症的老年人中普遍存在的睡眠障碍，即不宁腿综合症（RLS）。 RLS 的特点是腿部感觉不舒服，扰乱睡眠，并与健康和认知功能显着下降有关。患有痴呆症的老年人存在认知和语言缺陷，导致他们无法报告感官症状，并且没有有效的客观措施可以诊断他们的不宁腿综合症。这种综合征很可能出现在患有痴呆症的老年人身上，因为他们经常有不宁腿综合征的危险因素，如缺铁和服用多巴胺拮抗剂。腿部运动等运动活动、摩擦腿部等腿部不适迹象以及缺铁可能表明不宁腿综合征。美国国立卫生研究院 (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 测量方法，即不宁腿行为指标测试 (BI​​T-RL)。一项试点研究表明，患有不宁腿综合症的老年人和患有痴呆症的老年人在 BIT-RL 上具有较高的不宁腿综合症行为指标频率。我们还在 102 名患有痴呆症的老年人中发现，腿部运动的增加预示着患有痴呆症的老年人夜间睡眠的减少，这表明腿部运动可能是不宁腿综合征的一个标志。在本研究中，我们的目标是确定 BIT-RL 的敏感性、特异性和截止值（表明阳性诊断的仪器分数）；腿部运动的测量 - 定期活动监测器-RL；和血清铁蛋白。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表达自己的不宁腿综合症症状，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昼夜。盲态研究助理将使用 BIT-RL 和一晚的多导睡眠图来观察 RLS 行为，以筛查睡眠呼吸暂停。 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测器-RL 5 晚。训练有素的执业护士将进行约翰·霍普金斯大学 RLS 症状结构化诊断访谈，并做出 RLS 阳性或 RLS 阴性的诊断。接收器操作曲线将确定诊断 RLS 的最佳单一仪器或仪器组合。