NCT07355842 Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder
| NCT ID | NCT07355842 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zurich |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-01-15 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Andreas Luft, Prof. Dr. med.
PRINCIPAL INVESTIGATOR
University of Zurich
Frequently Asked Questions
Who can join the NCT07355842 clinical trial?
This trial is open to participants of all sexes, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07355842 currently recruiting?
Yes, NCT07355842 is actively recruiting participants. Contact the research team at jana.buenzli@usz.ch for enrollment information.
Where is the NCT07355842 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT07355842 clinical trial?
NCT07355842 is sponsored by University of Zurich. The principal investigator is Andreas Luft, Prof. Dr. med. at University of Zurich. The trial plans to enroll 80 participants.
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