The Role of Deep Sleep in Brain Changes in REM Sleep Behavior Disorder
Zusammenfassung der Studie
What is this study about? Many individuals with REM Sleep Behavior Disorder (iRBD) develop Parkinson's disease or similar conditions over the years. So far, there is no effective method to prevent this transition. Animal studies and observational studies in patients and older adults suggest that deeper sleep is associated with a slower progression of brain changes. In this study, we investigate whether deepening sleep through sounds during sleep can influence the progressive brain changes in iRBD or early Parkinson's disease. Study Procedure Participants will wear a headband with sensors and headphones for 18 months, which plays gentle sounds to deepen sleep during the night. Additionally, four examinations will take place, including tests for mobility, memory, imaging (PET/MRI), a lumbar puncture, and blood draws. Two of the examinations will be conducted at the University Hospital Zurich, while two others can be performed at home if desired. Study Goals The aim is to determine whether deepening sleep can help slow the progression of iRBD or early Parkinson's disease. The study is double-blind and controlled, meaning that neither participants nor researchers know who is receiving the active treatment. Benefits and Risks A direct benefit for participants is not guaranteed. However, the intervention is considered low-risk. Known risks such as mild headaches after the lumbar puncture or discomfort during imaging will be carefully monitored. Who can participate? We are looking for individuals with iRBD – even if an early Parkinson's disease is already present. Participation is voluntary and free of charge.
(BASEC)
Untersuchte Intervention
The study intervention aims to enhance the deep sleep activity of the brain using quiet sounds tailored to brain activity. This acoustic deep sleep enhancement is referred to as "Phase Targeted Auditory Stimulation" (PTAS), as the sounds are played at a specific point during the deep sleep waves of the brain. This approach increases the amplitude of deep sleep waves, thereby enhancing the intensity of deep sleep.
The deep sleep enhancement is conducted using the TOSOO Axora device. This device is a headband with sensors to measure brain activity and headphones to play the sounds. The device can be used independently at home after careful instruction. The technology has already been successfully applied in previous studies for deep sleep enhancement in patients with Parkinson's disease.
(BASEC)
Untersuchte Krankheit(en)
isolated REM sleep behavior disorder; Parkinson's disease
(BASEC)
Diagnosis of isolated REM sleep behavior disorder EITHER in combination with mild movement disorders and olfactory impairments OR in connection with newly diagnosed Parkinson's disease. Ability to perform the intervention (alone or with the help of a housemate) Sufficient German language skills to understand the study procedures (BASEC)
Ausschlusskriterien
CPAP therapy Clinically significant comorbidities (e.g., severe heart, kidney, or liver failure, restless legs syndrome, severe depression, schizophrenia, etc.) Exclusion criteria for PET examination (e.g., pacemakers, metal implants, etc.) (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
University of Zurich Represented by: Prof. Dr. med. Christian Baumann
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. phil. Angelina Maric
+41 44 255 86 15
angelina.maric@clutterusz.chUniversity Hospital Zurich Department of Neurology Frauenklinikstrasse 26 8091 Zurich
(BASEC)
Allgemeine Auskünfte
University of Zurich
+41 44 255 10 43+41 255 86 15
jana.buenzli@usz.changelina.maric@clutterusz.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
02.12.2025
(BASEC)
ICTRP Studien-ID
NCT07355842 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder (BASEC)
Wissenschaftlicher Titel
Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder (ICTRP)
Öffentlicher Titel
Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder (ICTRP)
Untersuchte Krankheit(en)
Parkinson DiseaseREM Sleep Behavior Disorder (iRBD) (ICTRP)
Untersuchte Intervention
Device: Tosoo AxoraDevice: Tosoo Axora (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Presynaptic Dopaminergic Integrity (ICTRP)
MDS-UPDRS Part III Score;Purdue Pegboard Test Score;Alternate Finger Tapping Test;UPDRS I.1 (subjective cognition);Montreal Cognitive Assessment (MoCA) Score;Trail Making Test Part A;Trail Making Test Part B;Digit Span Forward;Digit Span backward;Stroop Test;Verbal Fluency - Semantic;Benton Judgment of Line Orientation (BJLO);LPS-4 Logical Reasoning;Rey-Taylor Complex Figure Test - Copy;Rey-Taylor Complex Figure Test - Recall;California Verbal Learning Test (CVLT);Verbal Fluency - Phonemic;Boston Naming Test (BNT);WAIS Similarities (ICTRP)
Registrierungsdatum
22.12.2025 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University Hospital, Z�rich (ICTRP)
Weitere Kontakte
Andreas Luft, Prof. Dr. med.Jana Bnzli, MScAngelina Maric, Dr. phil., jana.buenzli@usz.changelina.maric@usz.ch, +41 44 255 10 43+41 255 86 15, University of Zurich (ICTRP)
Sekundäre IDs
2025-D0069, SloW-iRBD (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT07355842 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar