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| Name | Class |
|---|---|
| University of Florida Health | 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 55 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 gold-standard contrast enhanced MRI and non-invasive MRI-based 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-Sleep Deprivation | Experimental | Participant randomized to overnight sleep period with a morning wake period on first visit of cross-over study. |
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| Sleep Deprivation-Sleep Opportunity | Experimental | Participant randomized to overnight sleep deprivation period with a morning recovery sleep period on first visit of cross-over study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device measurements during overnight sleep and morning wake | Diagnostic Test | Overnight period and morning period device measurements |
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| Measure | Description | Time Frame |
|---|---|---|
| Contrast-enhanced MRI | Overnight sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by ROI parenchymal signal intensity using gold-standard contrast-enhanced MRI for gray and white matter ROI. | Immediately after the overnight sleep/wake period |
| Non-invasive MRI - diffusion-based intravoxel incoherent motion | Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using diffusion-based intravoxel incoherent motion (IVIM)-MRI (long-distance water transport) (diffusion signal, a.u.). | Immediately before and immediately after each sleep/wake period |
| Non-invasive MRI - fast functional MRI | Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using fast functional MRI (f-MRI) low-frequency vasomotor oscillations, Hz. | Immediately before and immediately after each sleep/wake period |
| Non-invasive MRI - T1/FLAIR-based assessment | Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using T1/FLAIR-based assessment of MRI-visible perivascular spaces (MVPVS) that are structural indicators of perivascular impairment, (a.u.). | Immediately before and immediately after each sleep/wake period |
| Non-invasive MRI - multi-echo arterial spin-labeling | Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using multi-echo arterial spin-labeling (ME-ASL)-MRI (glial-vascular water transport) (flow in ml/sec). |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep EEG | Device overnight sleep measurements (impedances in milli-ohms) correlations with overnight recorded sleep EEG power bands (relative delta, theta, alpha and beta power in %) and heart rate replicate pre-clinical correlations of glymphatic flow (measured using 2-photon microscopy in a.u.) with EEG power bands (relative delta, theta, alpha and beta power in %) and heart rate. | Measurements sampled every 5 to 10 minutes during the overnight sleep period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla Vandeweerd, PhD | UF Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health - Precision Health Research Center | The Villages | Florida | 32159 | 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
| Device measurements during overnight wake and morning sleep | Diagnostic Test | Overnight period and morning period device measurements |
|
| Immediately before and immediately after each sleep/wake period |
| Non-invasive MRI - phase-contrast | Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using phase-contrast (PC)-MRI (aqueductal cerebral spinal fluid (CSF) flow) (flow in ml/sec). | Immediately before and immediately after each sleep/wake period |
| Blood biomarkers | Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic clearance measured by amyloid beta40, beta42, n-tau 181, n-tau 217, p-tau 181, p-tau 217 blood biomarkers | Immediately before and immediately after each sleep/wake period |
| Cognitive function - trail making tests A&B | Overnight sleep- and wake-associated device measurements predict morning cognitive performance based on Trail Making Tests A&B (time in seconds). | Immediately after the sleep/wake period |
| Cognitive function - symbol digit modality test | Overnight sleep- and wake-associated device measurements predict morning cognitive performance based on symbol digit modality test (SDMT) (number correct). | Immediately after the sleep/wake period |
| Cognitive function - psychomotor vigilance test | Overnight sleep- and wake-associated device measurements predict morning cognitive performance based on psychomotor vigilance test (PVT) (mean and standard deviation of reaction time). | Immediately after the sleep/wake period |
| Cognitive function - digits forward recall | Overnight sleep- and wake-associated device measurements predict morning cognitive performance based on digits forward recall (maximum number of correctly recalled digits). | Immediately after the sleep/wake period |