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| Name | Class |
|---|---|
| University of Washington | OTHER |
| Oregon Health and Science University | OTHER |
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This is a cross-over randomized study to validate the Sponsor investigational medical device against measurements of glymphatic function from MRI-based neuroimaging, EEG, blood biomarkers and cognitive tests in healthy older volunteers.
The study population will consist of healthy individuals, ages 50 to 65, that are cognitively normal and do not have a medical history of neurological or sleep disorder, cardiovascular disease, hypertension, or diabetes. The objectives of this study are to define whether sleep- and wake-associated device measurements (i) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function; (ii) replicate pre-clinical findings between sleep EEG power bands and glymphatic flow; (iii) predict plasma levels of Alzheimer's disease (AD)-related biomarkers; and (iv) predict morning cognitive performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Opportunity | Experimental | Overnight sleep wearing the device |
|
| Sleep Deprivation | Experimental | Overnight awake wearing the device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device measurements | Diagnostic Test | Overnight device measurements |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRI | Define whether sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function: (i) diffusion-based intravoxel incoherent motion (IVIM)-MRI (long-distance water transport) (diffusion signal, a.u.), (ii) fast functional MRI (f-MRI) low-frequency vasomotor oscillations, Hz, (iii) T1/FLAIR-based assessment of MRI-visible perivascular spaces (MV-PVS) that are structural indicators of perivascular impairment, (a.u.); (iv) multi-echo arterial spin-labeling (ME-ASL)-MRI (glial-vascular water transport) (flow in ml/sec); (v) and phase-contrast (PC)-MRI (aqueductal cerebral spinal fluid (CSF) flow) (flow in ml/sec). | Immediately before and immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep EEG | Correlations between device overnight measurements (impedances in milli-ohms) and overnight recorded EEG power bands (relative delta, theta, alpha and beta power in %) replicate pre-clinical correlations of glymphatic flow (measured using 2-photon microscopy in a.u.) and EEG power bands (relative delta, theta, alpha and beta power in %). | During the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Dagum, MD PhD | Applied Cognition, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Department of Radiology (DISC) | Seattle | Washington | 98195 | United States |
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Cross-over randomized study
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Visit type was masked to neuroimaging assessors and blood biomarker analysis laboratory.
| Blood biomarkers | Device overnight measurements predict overnight changes in amyloid beta40, beta42, n-tau 181, n-tau 217, p-tau 181, p-tau 217 blood biomarkers. | Immediately before and immediately after the intervention |
| Cognitive function | Device overnight measurements predict morning cognitive performance based on aggregated standardized scores (mean of 0 and standard deviation of 1) of Trail Making Tests A&B (time in seconds), symbol digit modality test (SDMT) (number correct), psychomotor vigilance test (PVT) (mean and standard deviation of reaction time) and digits forward recall (maximum number of correctly recalled digits). | Immediately after the intervention |