NCT07355842Recruiting
Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 22 Dec 2025
- Start date
- 15 Jan 2026
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- University of Zurich
- Diseases
- Parkinson disease
- NCT number
- NCT07355842
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 15 Jan 2026 to the primary completion date, 30 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Suspected or known non-compliance to other therapies
- clinically significant concomitant disease or unstable condition
- recent or planned major surgery
Other illness
- hearing impairment that prevents hearing the tones for auditory stimulation
- 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
- current or recent history within the last year of substance abuse disorders or chronic alcohol consumption
- history of allergies and hypersensitivity relevant for electrode application or medication allergies
Other
- current or recent participation in another clinical trial
- extended absences
- non-responder to auditory stimulation during screening
- Apnea-Hypopnea-Index (AHI) \> 15/h or under Continuous Positive Airway Pressure (CPAP) treatment
- regular use of benzodiazepines and other central nervous system depressant substances
- 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
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Zurich, Neurology Department Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.