Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari , Asse Didattico E., SS 554 Bivio Sestu, Monserrato, 09042, Cagliari, Italy.
Department of Neuroscience, Biomedicine and Movement, University of Verona, Verona, Italy.
Neurol Sci. 2022 Dec;43(12):6919-6928. doi: 10.1007/s10072-022-06374-4. Epub 2022 Sep 10.
Most patients with idiopathic REM sleep behavior disorder (iRBD) will develop an overt α-synucleinopathy over time, with a rate of phenoconversion of 73.5% after 12 years from diagnosis. Several markers of phenoconversion were identified; however, most studies investigated biomarkers separately, with retrospective study designs, in small cohorts or without standardized data collection methods. The risk FActoRs PREdictive of phenoconversion in idiopathic REM sleep behavior disorder: the Italian STudy (FARPRESTO) is a multicentric longitudinal retrospective and prospective study with a cohort of incident (prospective recruitment) and prevalent (retrospective recruitment) iRBD patients, whose primary aim is to stratify the risk of phenoconversion, through the systematic collection by means of electronic case report forms of different biomarkers. Secondary aims are to (1) describe the sociodemographic and clinical characteristics of patients with iRBD; (2) collect longitudinal data about the development of α-synucleinopathies; (3) monitor the impact of iRBD on quality of life and sleep quality; (4) assess the correlation between phenoconversion, cognitive performance, and loss of normal muscle atony during REM sleep; (5) identify RBD phenotypes through evaluating clinical, biological, neurophysiological, neuropsychological, and imaging biomarkers; and (6) validate vPSG criteria for RBD diagnosis. The FARPRESTO study will collect a large and harmonized dataset, assessing the role of different biomarkers providing a unique opportunity for a holistic, multidimensional, and personalized approach to iRBD, with several possible application and impact at different levels, from basic to clinical research, and from prevention to management. The FARPRESTO has been registered at clinicaltrials.gov (NCT05262543).
大多数特发性 REM 睡眠行为障碍（iRBD）患者随着时间的推移会发展为明显的α-突触核蛋白病，从诊断后 12 年起，其表型转化率为 73.5%。已经确定了一些表型转化的标志物；然而，大多数研究都是单独研究生物标志物，采用回顾性研究设计，在小队列中或没有标准化的数据收集方法。特发性 REM 睡眠行为障碍表型转化的风险因素预测：意大利研究（FARPRESTO）是一项多中心纵向回顾性和前瞻性研究，其队列包括新发（前瞻性招募）和现患（回顾性招募）iRBD 患者，其主要目的是通过电子病例报告表系统地收集不同的生物标志物来分层表型转化的风险。次要目的是：(1) 描述 iRBD 患者的社会人口统计学和临床特征；(2) 收集关于α-突触核蛋白病发展的纵向数据；(3) 监测 iRBD 对生活质量和睡眠质量的影响；(4) 评估表型转化、认知表现和 REM 睡眠中正常肌肉弛缓丧失之间的相关性；(5) 通过评估临床、生物学、神经生理学、神经心理学和影像学生物标志物来识别 RBD 表型；(6) 验证 vPSG 标准用于 RBD 诊断。FARPRESTO 研究将收集大量且协调的数据，评估不同生物标志物的作用，为 iRBD 提供一个独特的整体、多维和个性化的方法，在基础研究、临床研究、预防和管理等不同层面具有多种可能的应用和影响。FARPRESTO 已在 clinicaltrials.gov 注册（NCT05262543）。
