NCT07355842

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Many people with REM sleep behavior disorder (iRBD) develop Parkinson's disease or similar conditions over the years. To date, there is no effective method to prevent this transition. Animal experiments and observational studies in patients and older adults indicate that deeper sleep is associated with a slower progression of brain changes. In this study, we are now investigating whether enhancement of deep sleep using sounds during sleep can influence the progressive brain changes in iRBD or early Parkinson's disease. Participants wear a headband with sensors and headphones for 18 months, which plays gentle sounds during sleep to enhance deep sleep. In addition, four examinations are carried out, including tests of mobility, memory, imaging (PET/MRI), a lumbar puncture, and blood sampling. Two of the examinations will take place at the University Hospital of Zurich, and two more can also be carried out at home if desired. The aim is to investigate whether enhancement of deep sleep can help slow the progression of iRBD or early-stage Parkinson's disease. The study is double-blind and controlled, which means that neither the participants nor the researchers know who is receiving the active treatment.

Conditions

• Parkinson Disease
• REM Sleep Behavior Disorder (iRBD)

Interventions

Type	Name	Description
DEVICE	Tosoo Axora	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.
DEVICE	Tosoo Axora	Auditory stimuli will be delivered during the night through integrated headphones with a portable EEG device in a non-PTAS manner.

Timeline

• Start date: 2026-01-15
• Primary completion: 2029-06-30
• Completion: 2029-06-30
• First posted: 2026-01-21
• Last updated: 2026-02-17

Locations

1 site across 1 country: Switzerland