Actively Recruiting
Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder
Led by University of Zurich · Updated on 2026-02-17
80
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
Sponsors
U
University of Zurich
Lead Sponsor
U
University Hospital, Zürich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Parkinson's disease less than 2 years
- No dopaminergic treatment and no planned start of such treatment during the study
- Ability to apply the intervention alone or with help in a stable living situation
- Sufficient language skills in German, French, or Italian
- Negative pregnancy test for women who can become pregnant
You will not qualify if you...
- Suspected or known non-compliance to other therapies
- Current or recent participation in another clinical trial
- Extended absences
- Hearing impairment preventing hearing of auditory stimulation tones
- Non-responder to auditory stimulation during screening
- Clinically significant concomitant disease or unstable condition
- Apnea-Hypopnea-Index (AHI) > 15/h or under CPAP treatment
- Restless Legs Syndrome
- Diagnosis of atypical Parkinson syndrome
- Diagnosis of Dementia or Montreal Cognitive Assessment (MoCA) score < 24
- Severe depression or other psychiatric disorder
- Regular use of benzodiazepines or other central nervous system depressants
- Current or recent history within last year of substance abuse or chronic alcohol consumption
- Recent or planned major surgery
- History of allergies or hypersensitivity relevant to electrodes or medication
- Additional exclusion criteria for PET imaging
- Any condition posing participant risk
- Breastfeeding, intending pregnancy, or unwillingness to use reliable contraception for women of child-bearing potential
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Zurich, Neurology Department
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
Research Team
J
Jana Bünzli, MSc
CONTACT
M
Marta Menéndez, Dr. phil.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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