Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder (NCT07355842) | Clinical Trial Compass
RecruitingNot Applicable
Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder
Switzerland80 participantsStarted 2026-01-15
Plain-language 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.
Who can participate
SexALL
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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 concomitant disease or unstable condition
* Apnea-Hypopnea-Index (AHI) \> 15/h or under Continuous Positive Airway Pressure (CPAP) treatment
* Restless Legs Syndrome
* meeting criteria for diagnosis of atypical Parkinson syndrome
* diagnosis of Dementia or Montreal Cognitive Assessment (MoCA) \< 24
* severe Depression or other psychiatric disorder
* regular use of benzodiazepines and other central nervous system depressant substances
* current or recent history within the last year of substance abus…
What they're measuring
1
Presynaptic Dopaminergic Integrity
Timeframe: assessed at Baseline Visit and Closeout Visit (after 18 months)