Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study tests whether enhancing deep sleep with gentle sounds at night can slow progression in people with iRBD or early Parkinson's disease. Participants wear a sensor headband and headphones for 18 months. Four assessments including mobility, memory, imaging (PET/MRI), lumbar puncture, and blood tests are assessed.
Eligibility Criteria
Inclusion Criteria: * Signed informed consent * Diagnosis of polysomnography-confirmed isolated REM Sleep Behavior Disorder (iRBD) based on international criteria (ICSD-3), combined with EITHER * UPDRS III without action tremor ≥ 4 AND abnormal olfaction, OR * diagnosis of PD along international criteria for less than 2 years Further inclusion criteria are: * no dopaminergic treatment and no foreseen start of such treatment during duration of the study * ability to apply the intervention, alone or with help of a co-habitant, stable living situation * sufficient language skills in German, French or Italian * negative pregnancy test for women of child-bearing potential Exclusion Criteria: * Suspected or known non-compliance to other therapies * current or recent participation in another clinical trial * extended absences * hearing impairment that prevents hearing the tones for auditory stimulation * non-responder to auditory stimulation during screening * clinically significant concomita