ClinicalTrials.gov lists this study as Recruiting.
Official title: Combating Alzheimer's Through Sleep and Exercise (CASE)
Enrollment: 60 participants (Estimated).
What is being studied
Device: Elemind Neuromodulation Headband
Other: Exercise Routine
Who may be eligible
Ages
55 Years to 80 Years
Sex
All
Healthy volunteers accepted
Yes
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
1. Aged 55-80 years at the time of the screening visit
2. Able to ambulate safely and independently
3. Able to safely perform moderate-intensity exercise as per the Physical Activity Readiness Questionnaire (PAR-Q, a validated exercise readiness questionnaire)
4. Able to wear and use Fitbit wristwatch and/or the Elemind Neuromodulation headband and Lys devices
5. Able to operate a digital device like mobile phone or computer
6. Able and willing to provide venous blood samples
7. Able to understand and speak English (our AR-based MCI diagnosis tool does not yet have capacity for other languages)
8. Able to self-report a history of cognitive changes or impairment
9. Be cognitively able (including those with and without MCI) and willing to provide informed consent
10. Body weight \<400 pounds (\<181.4kg) in order to safely operate the NuStep T4r Recumbent Stepper stationary bicycle
Exclusion Criteria:
1. Severe mobility limitations that prevent safe participation in moderate exercise protocols
2. Unstable or uncontrolled medical conditions (e.g., recent cardiovascular event (\<6 months), cerebrovascular accident or transient ischemic attack (\<6 months), active cancer, or uncontrolled diabetes) that pose safety concerns
3. Inability to complete intake screening procedures
4. Severe uncorrected hearing impairment-particularly if it precludes effective utilization of the Elemind Neuromodulation headband-and/or vision impairment that interferes with digital device usage or in-person exercise guidance
5. Determined to have Alzheimer's/dementia based on performance on the Quick Mild Cognitive Impairment (QMCI).
6. Inability or unwillingness to learn or engage with digital devices (e.g., smartphone, Fitbit, Elemind, or Lys), even with staff support
7. Regular pre-study engagement in ≥150 minutes of moderate-level and/or ≥75 minutes of vigorous-level exercise per week based on Fitbit data obtained during the initial seven-day onboarding screening period
8. Determined to have sufficient sleep, as defined by a sleep efficiency mean of ≥80%) based on Elemind Neuromodulation headband data obtained during the initial seven-day onboarding screening period
9. Current usage of disease-modifying therapy targeting amyloid (e.g., anti-amyloid monoclonal antibodies) or tau
10. Body weight ≥400 pounds (≥181.4kg), which would pose a safety risk during the operation of the NuStep recumbent stationary bicycle
Study locations
1 study location is listed.
Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.
Countries: United States
Florida, United States: 1
Sample of listed locations
University of Miami Hospitals — Miami, Florida, 33136, United States — Recruiting
Study details
Start date
March 1, 2023
Primary completion date
December 30, 2028
Completion date
December 30, 2028
First posted
April 22, 2021
Collaborators
Altoida, Elemind Technologies, Inc., Fitbit LLC, Shipley Foundation
Trial information can change. Confirm current study details with the study team or the registry.
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