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

NCT07355842 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-17

No results posted yet for this study

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

  • Parkinson Disease
  • REM Sleep Behavior Disorder (iRBD)

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Zürich

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

  • Andreas Luft, Prof. Dr. med. · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07355842 on ClinicalTrials.gov