This study aims to characterize neurodegeneration progression in patients with polysomnography (PSG)-confirmed longstanding idiopathic REM sleep behavior disorder (iRBD) and to develop a prognostic model for clinical evolution and earlier identification of cases at risk of short-term conversion to clinically defined Parkinson's disease (PD).
The study uses a multiparametric approach combining longitudinal clinical, neuropsychological, quantitative PSG, and multiparametric brain MRI markers (structural MRI, diffusion tensor imaging, resting-state functional MRI) to track neurodegeneration from the prodromal stage of PD and predict individual disease evolution.
50 patients with PSG-confirmed iRBD (duration since diagnosis greater than or equal to 5 years) and 50 age- and sex-matched healthy controls will be assessed at baseline and every year for 3 years at IRCCS Ospedale San Raffaele, Milan, Italy.
Inclusion Criteria (both patients and healthy controls):
Right-handed participants.
Monolingual native Italian speakers.
Age between 50 and 75 years old.
Normal or corrected-to-normal visual acuity.
Mini Mental State Examination (MMSE) score greater than 24.
Oral and written informed consent to study participation.
Additional inclusion criteria for iRBD patients:
Diagnosis of iRBD based on International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria: presence of REM sleep without atonia; presence of sleep-related injurious-disruptive behaviors by history or abnormal sleep behaviors documented during PSG monitoring; absence of EEG epileptiform activity during REM sleep; presence of sleep disturbance not better explained by another sleep disorder, medical or neurologic disorder, mental disorder, medication use, or substance use disorder.
PSG-confirmed iRBD duration since diagnosis equal or greater than 5 years.
Absence of clinically defined Parkinson's disease.
Exclusion Criteria for iRBD patients:
Exclusion Criteria for Healthy Controls:
50 patients with polysomnography (PSG)-confirmed longstanding idiopathic REM sleep behavior disorder (iRBD), with iRBD duration since diagnosis equal or greater than 5 years, without a clinically defined Parkinson's disease. Recruited from outpatient patients of the Department of Neurology, San Raffaele Hospital, Turro, Milan.
50 healthy subjects similar for age (range 50-75 years old) and sex to patients with iRBD, recruited among non-consanguineous relatives, institute personnel and by word of mouth. They undergo PSG at study entry to exclude sleep disorders.
Milan, Milano 20127, Italy
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