Study of Risk Factors Predicting Progression in Idiopathic REM Sleep Behavior Disorder in Italy

What this Trial Is About

REM Sleep Behavior Disorder RBD is a condition where the normal muscle paralysis during REM sleep is lost, causing abnormal and sometimes violent movements often linked to dreams. This disorder can exist on its own, called idiopathic RBD iRBD, or be associated with neurological diseases like Parkinsons Disease and Lewy Body Dementia. Researchers are studying RBD to understand its progression and to identify markers that predict when iRBD patients may develop related neurodegenerative diseases, as well as to characterize different patient subtypes and quality of life impacts. The study is observational and collects clinical, biological, neurophysiological, neuropsychological, and imaging data from participants diagnosed with iRBD. These data are gathered using standardized and harmonized procedures to identify predictive risk factors and distinct phenotypes of iRBD. The goal is to create a well-characterized group of patients ready for future trials of disease-modifying therapies, including monoclonal antibodies targeting alpha-synucleinopathies. Participants will be followed over many years, with assessments including video-polysomnographic recordings vPSG, clinical exams, questionnaires, and imaging tests. Researchers will track the development of alpha-synucleinopathies, quality of life changes, and correlations between muscle activity loss during REM sleep and cognitive performance. The primary outcome is identifying risk factors for disease progression, with monitoring continuing through January 2035 to capture long-term data on conversion rates and patient well-being.

PREdictive Risk Factors of Conversion Into Idiopathic RBD. Italian Study