Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Zurich
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tosoo Axora
- Tosoo Axora
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Zurich
Lead sponsor
University Hospital, Zürich
Collaborator
Source ClinicalTrials.gov