Continuous Measurement of Glymphatic Activity in the Human Brain During Sleep-Wake States

NCT06060054 | Completed FDA Device

• 1 other identifier: AC.2022.03
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Sleep EEG

  During the intervention

• Blood biomarkers

  Immediately before and immediately after the intervention

• Cognitive function

  Immediately after the intervention

Study Arms (2)

Sleep Opportunity

EXPERIMENTAL

Overnight sleep wearing the device

Diagnostic Test: Device measurements

Sleep Deprivation

EXPERIMENTAL

Overnight awake wearing the device

Diagnostic Test: Device measurements

Interventions

Device measurements DIAGNOSTIC_TEST

Overnight device measurements

Sleep Deprivation; Sleep Opportunity

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have a Montreal Cognitive Assessment (MoCA) score at least 26.
• Participants must have a Geriatric Depression Scale (GDS) 15-item score of 4 or less.

You may not qualify if:

• Participants with a formal diagnosis of any sleep disorder (e.g., sleep apnea on positive-airway-pressure (PAP) therapy, insomnia, restless leg syndrome, circadian rhythm sleep disorder, parasomnia).
• Participants with a history of significant neurological disease or history of epilepsy.
• Participants with cardiovascular disease or cardiovascular risk factors (smoking or hypertension).
• Participants with diabetes.
• Participants with traumatic brain injury, or serious mental illness including bipolar disorder, schizophrenia, major depressive disorder or post-traumatic stress disorder.
• Participants who have taken in the past 30 days prescribed or over-the-counter (OTC) stimulants, sleeping medications, or psychiatric medications including antidepressants.
• Participants who consume more than 400 mg/day of caffeine. Participants will be required to not consume caffeine beginning 12pm on the day-of the sleep study.
• Female Participants who consume more than 3 alcoholic drinks on any day or more than 7 drinks per week. Male participants who consume more than 4 alcoholic drinks on any day or more than 14 drinks per week.
• Participants who have or will have travelled across time zones 10 days prior to either Study Visit or whose first and second Study Visits span Daylight Savings time change (November 6, 2022).
• Participants with travel plans or conflicts that would prevent them from either Study Visit.
• Participants who are enrolled in other research studies and are receiving an investigational drug within 30 days of the planned start date.
• Participants who have any condition that, in the opinion of the Sponsor Principal Investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements.
• Participants with absolute or relative contraindications to MRI imaging based on current up-to-date screening questionnaires including claustrophobia, inability to lie still on their back for 30-45 minutes or require sedation prior to the MRI.
• Participants with a head circumference greater than 60 cm that would prevent use of a high-resolution 64 channel MRI head coil required for this study
• Participants who have a pre-planned surgery or medical procedure that would interfere with the conduct of the study.

Sponsors & Collaborators

• Applied Cognition: lead
• University of Washington: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

University of Washington Department of Radiology (DISC)

Seattle, Washington, 98195, United States

Location

Study Officials

• Paul Dagum, MD PhD

  Applied Cognition, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Visit type was masked to neuroimaging assessors and blood biomarker analysis laboratory.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cross-over randomized study

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: September 29, 2023
• Study Start: November 1, 2022
• Primary Completion: May 10, 2023
• Study Completion: May 10, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

US (1)