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

ConditionsParkinson Disease REM Sleep Behavior Disorder (iRBD)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Verum armExperimental treatment 1 intervention

Group B: Sham armSham comparator 1 intervention

Trial outcomes

Primary outcomes

Presynaptic Dopaminergic Integrity

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

Time frame

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

Secondary outcomes

MDS-UPDRS Part III Score

Motor symptom severity assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III), a clinician-rated examination of motor signs.

Time frame

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

Purdue Pegboard Test Score

Manual dexterity and fine motor coordination assessed by total score on the Purdue Pegboard Test.

Time frame

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

Alternate Finger Tapping Test

Motor speed and coordination assessed by performance on the Alternate Finger Tapping Test.

Time frame

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

UPDRS I.1 (subjective cognition)

Patient-reported cognitive experiences of daily living assessed by MDS-UPDRS Part I, Item 1.1.

Time frame

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

Other outcomes

Exploratory Outcome: Home Sleep EEG - Sleep Microstructure

NREM sleep oscillatory activity and microstructural features measured by portable EEG device (Tosoo Axora) during nightly use, including but not limited to slow wave activity, sleep spindles, and their temporal dynamics.

Time frame

Continuous over 18 months

Exploratory Outcome: Home Sleep EEG - Sleep Macrostructure

Sleep architecture and derived metrics measured by portable EEG device (Tosoo Axora) during nightly use, including sleep stage distribution, sleep continuity, and sleep timing parameters.

Time frame

Continuous over 18 months

Exploratory Outcome: MRI

Neuroanatomical and vascular markers assessed by brain MRI, including structural imaging, phase-contrast imaging, arterial spin labeling, and related sequence

Time frame

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

Exploratory Outcome: 18F-DOPA PET - Exploratory Parameters

Exploratory PET parameters including visual assessment of striatal uptake patterns, influx constant (Ki), and F-DOPA distribution beyond predefined regions of interest

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Zurich

Lead sponsor

University Hospital, Zürich

Collaborator

Source ClinicalTrials.gov

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