Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder

NCT07355842 | Recruiting

• 2 other identifiers: SloW-iRBD2025-D0069
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

REM Sleep Behavior Disorder (iRBD); Parkinson Disease

Keywords

Parkinson; Parkinson disease; Sleep; Neurodegeneration; Auditory stimulation; iRBD; REM sleep behavior disorder

Outcome Measures

Primary Outcomes (1)

• Presynaptic Dopaminergic Integrity

  Striatal dopaminergic function as measured by high-resolution 18F-Fluorodopa (18F-DOPA)-PET imaging.

  assessed at Baseline Visit and Closeout Visit (after 18 months)

Secondary Outcomes (19)

• MDS-UPDRS Part III Score

  assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout))

• Purdue Pegboard Test Score

  assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout))

• Alternate Finger Tapping Test

  assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout))

• UPDRS I.1 (subjective cognition)

  assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout))

• Montreal Cognitive Assessment (MoCA) Score

  assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)

Other Outcomes (23)

• Exploratory Outcome: Home Sleep EEG - Sleep Microstructure

  Continuous over 18 months

• Exploratory Outcome: Home Sleep EEG - Sleep Macrostructure

  Continuous over 18 months

• Exploratory Outcome: MRI

  assessed at Baseline Visit and Closeout Visit (after 18 months)

Study Arms (2)

Verum arm

EXPERIMENTAL

Nightly enhancement of slow waves through Phase Targeted Auditory Stimulation (PTAS) over 18 months.

Device: Tosoo Axora

Sham arm

SHAM COMPARATOR

Nightly application of tones that will be applied in a non-PTAS manner, resulting in no enhancement of slow waves over 18 months.

Device: Tosoo Axora

Interventions

Tosoo Axora DEVICE

Phase Targeted Auditory Stimulation (PTAS) will be applied through integrated headphones with a portable EEG device when non-rapid-eye-movement (NREM) sleep is detected during the night.

Also known as: PTAS Intervention (Verum)

Verum arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• University Hospital, Zürich: collaborator

Study Sites (1)

University Hospital Zurich, Neurology Department

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; REM Sleep Behavior Disorder; Nerve Degeneration

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Luft, Prof. Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jana Bünzli, MSc

CONTACT

+41 44 255 10 43; jana.buenzli@usz.ch

Marta Menéndez, Dr. phil.

CONTACT

+41 43 253 69 54; marta.menendezgranda@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 21, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)