Gentle nighttime sounds to boost deep sleep and slow brain changes in iRBD and early Parkinson's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants wear a sensor headband and headphones nightly for 18 months while receiving either timed gentle auditory stimulation or a control condition in a double-blind, controlled design. The protocol includes four comprehensive assessments of motor function, cognition, PET/MRI imaging, lumbar puncture, and blood biomarkers, with two visits at University Hospital Zurich and two that can be done at home. Eligible participants have polysomnography-confirmed iRBD with early motor/olfactory signs or a Parkinson's diagnosis under two years and must not be on dopaminergic therapy during the study. Outcomes combine imaging and biomarker changes with mobility and cognitive measures to determine whether boosting slow-wave sleep alters disease progression.

Why it matters

Who can join: the full rules

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 abuse disorders or chronic alcohol consumption
* recent or planned major surgery
* history of allergies and hypersensitivity relevant for electrode application or medication allergies
* additional exclusion criteria for PET imaging
* any criterion that may pose the participant at risk
* breastfeeding, intention to become pregnant, or unwillingness to use medically reliable contraception for women of child-bearing potential

Where it's running

• University Hospital Zurich, Neurology Department
  Zurich, Canton of Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Andreas Luft, Prof. Dr. med. — University of Zurich
• Study coordinator: Jana Bünzli, MSc
• Email: jana.buenzli@usz.ch
• Phone: +41 44 255 10 43

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.