Applied Cognition Benchmarking Study

NCT06222385 | Completed FDA Device

• 1 other identifier: AC.2022.02
• Study Type: interventional
• Target: 34
• 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 (6)

• 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).

  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

Secondary Outcomes (6)

• Sleep EEG

  Measurements sampled every 5 to 10 minutes during the overnight sleep period

• Blood biomarkers

  Immediately before and immediately after each sleep/wake period

• Cognitive function - trail making tests A&B

  Immediately after the sleep/wake period

• Cognitive function - symbol digit modality test

  Immediately after the sleep/wake period

• Cognitive function - psychomotor vigilance test

  Immediately after the sleep/wake period

Study Arms (2)

Sleep Opportunity-Sleep Deprivation

EXPERIMENTAL

Participant randomized to overnight sleep period with a morning wake period on first visit of cross-over study.

Diagnostic Test: Device measurements during overnight sleep and morning wake

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.

Diagnostic Test: Device measurements during overnight wake and morning sleep

Interventions

Device measurements during overnight sleep and morning wake DIAGNOSTIC_TEST

Overnight period and morning period device measurements

Sleep Opportunity-Sleep Deprivation

Device measurements during overnight wake and morning sleep DIAGNOSTIC_TEST

Overnight period and morning period device measurements

Sleep Deprivation-Sleep Opportunity

Eligibility Criteria

• Age: 55 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 overthe- 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 planning travel to alternate time zones within two weeks of study participation
• 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 Florida Health: collaborator

Study Sites (1)

UF Health - Precision Health Research Center

The Villages, Florida, 32159, United States

Location

Study Officials

• Carla Vandeweerd, PhD

  UF Health

  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: January 4, 2024
• First Posted: January 24, 2024
• Study Start: November 7, 2022
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

US (1)