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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-D0069 | Other Identifier | BASEC |
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| Name | Class |
|---|---|
| University Hospital, Zürich | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum arm | Experimental | Nightly enhancement of slow waves through Phase Targeted Auditory Stimulation (PTAS) over 18 months. |
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| Sham arm | Sham Comparator | Nightly application of tones that will be applied in a non-PTAS manner, resulting in no enhancement of slow waves over 18 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Presynaptic Dopaminergic Integrity | Striatal dopaminergic function as measured by high-resolution 18F-Fluorodopa (18F-DOPA)-PET imaging. | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Purdue Pegboard Test Score |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Continuous over 18 months |
| Exploratory Outcome: Home Sleep EEG - Sleep Macrostructure |
Inclusion Criteria:
Further inclusion criteria are:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jana Bünzli, MSc | Contact | +41 44 255 10 43 | jana.buenzli@usz.ch | |
| Marta Menéndez, Dr. phil. | Contact | +41 43 253 69 54 | marta.menendezgranda@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Luft, Prof. Dr. med. | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Neurology Department | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020187 | REM Sleep Behavior Disorder |
| D009410 | Nerve Degeneration |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Tosoo Axora | Device | Auditory stimuli will be delivered during the night through integrated headphones with a portable EEG device in a non-PTAS manner. |
|
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Manual dexterity and fine motor coordination assessed by total score on the Purdue Pegboard Test. |
| 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. | 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. | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Montreal Cognitive Assessment (MoCA) Score | Global cognitive function assessed by MoCA total score. | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout) |
| Trail Making Test Part A | Processing speed and attention assessed by time to completion on Trail Making Test Part A. | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Trail Making Test Part B | Executive function assessed by time to completion on Trail Making Test Part B. | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Digit Span Forward | Attention assessed by Digit Span Forward from the Wechsler Adult Intelligence Scale. | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Digit Span backward | Working memory assessed by Digit Span Backward from the Wechsler Adult Intelligence Scale | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Stroop Test | Executive function and inhibitory control assessed by Stroop Color-Word Test. | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Verbal Fluency - Semantic | Semantic verbal fluency assessed by category fluency task. | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Benton Judgment of Line Orientation (BJLO) | Visuospatial function assessed by Benton Judgment of Line Orientation test. | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| LPS-4 Logical Reasoning | Logical reasoning assessed by Leistungsprüfsystem subtest 4. | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| Rey-Taylor Complex Figure Test - Copy | Visuoconstruction assessed by copy trial of the Rey-Taylor Complex Figure Test. | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| Rey-Taylor Complex Figure Test - Recall | Visual memory assessed by delayed recall of the Rey-Taylor Complex Figure Test. | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| California Verbal Learning Test (CVLT) | Verbal learning and memory assessed by California Verbal Learning Test. | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| Verbal Fluency - Phonemic | Phonemic verbal fluency assessed by letter fluency task. | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| Boston Naming Test (BNT) | Naming and language function assessed by Boston Naming Test | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| WAIS Similarities | Verbal abstract reasoning assessed by similarities subtest from the Wechsler Adult Intelligence Scale | assessed at Baseline Visit and Closeout Visit (after 18 months) |
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. |
| 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 | 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 | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| Exploratory Outcome: Psychomotor Vigilance Task (PVT) | Sustained attention and reaction time assessed by the Psychomotor Vigilance Task. | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Exploratory Outcome: Sustained Attention to Response Task (SART) | Vigilance and response inhibition assessed by the Sustained Attention to Response Task. | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Exploratory Outcome: Glucose Metabolism | Glucose metabolism (HbA1c, glycosylated hemoglobin) will be assessed to explore glucose tolerance and control through a simple blood draw. | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| Exploratory Outcome - Polysomnography - Sleep Architecture | Sleep macrostructure including total sleep time, sleep efficiency, and sleep stage distribution assessed by in-laboratory polysomnography. | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| Exploratory Outcome: Polysomnography - REM Sleep Without Atonia | REM sleep without atonia (RWA) quantified as percentage of REM sleep with elevated muscle tone on polysomnography. | assessed at Baseline and Closeout (18 months) |
| Exploratory Outcome: Actigraphy - Sleep-Wake Patterns | Sleep-wake rhythm including total sleep time, sleep efficiency, and rest-activity patterns assessed by wrist actigraphy over 2-week periods. | assessed before/after each visit (Baseline, after 6 months, after 12 months, Closeout (18 months)) for 2 weeks each |
| Exploratory Outcome: Sleep Diary | Self-reported sleep timing, duration, and quality recorded daily over 2-week periods. | Assessed before/after each visit (Baseline, after 6 months, after 12 months, Closeout (18 months)) for 2 weeks each |
| Exploratory Outcome: Sleep Quality- Visual Analog Scale - | Subjective sleep quality assessed by Visual Analog Scale. | assessed before/after each visit (Baseline, after 6 months, after 12 months, Closeout (18 months)) for 2 weeks each |
| Exploratory Outcome - Karolinska Sleepiness Scale (KSS) | Subjective daytime sleepiness assessed by Karolinska Sleepiness Scale. | assessed before/after each visit (Baseline, after 6 months, after 12 months, Closeout (18 months)) for 2 weeks each |
| Exploratory Outcome: Retinal Nerve Fiber Layer Thickness (RNFL) | Retinal nerve fiber layer thickness measured by optical coherence tomography (OCT) | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| Exploratory Outcome: Ganglion Cell-Inner Plexiform Layer Thickness (GCIPL) | Ganglion cell-inner plexiform layer thickness measured by optical coherence tomography (OCT) | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| Exploratory Outcome: Macular Vessel Density (MVD) | Macular vessel density measured by optical coherence tomography angiography (OCT-A) | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| Exploratory Outcome: Non-Motor Symptoms Scale (NMSS) | Non-motor symptom severity and frequency assessed by the Non-Motor Symptoms Scale, a 30-item questionnaire covering nine symptom dimensions | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Exploratory Outcome: Epworth Sleepiness Scale (ESS) | Daytime sleepiness assessed by the Epworth Sleepiness Scale (8-item self-report questionnaire) | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Exploratory Outcome: Parkinson's Disease Sleep Scale-2 (PDSS-2) | Sleep disturbances assessed by the PDSS-2, a 15-item self-administered questionnaire covering motor problems at night, PD-specific nocturnal symptoms, and disturbed sleep. | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Exploratory Outcome: Ikelos Rating Scale | RBD symptom severity assessed by the Ikelos Rating Scale, evaluating frequency and severity of REM sleep behavior disorder | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Exploratory Outcome: Exploratory Outcome: EQ-5D-5L | Health-related quality of life assessed by the EQ-5D-5L questionnaire, covering mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, plus visual analogue scale | assessed at each visit (Baseline, after 6 months, after 12 months, after 18 months (Closeout)) |
| Exploratory Outcome: Blood Biomarkers | Neurodegenerative and inflammatory markers measured in blood, including neurofilament light chain (NfL) and alpha-synuclein | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| Exploratory Outcome: CSF Biomarkers | Neurodegenerative and inflammatory markers measured in cerebrospinal fluid, including amyloid-β, tau, alpha-synuclein, and neurofilament light chain (optional, for participants who consent to lumbar puncture) | assessed at Baseline Visit and Closeout Visit (after 18 months) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |