Combating Alzheimer's Through Sleep and Exercise
University of Miami · with Shipley Foundation, Elemind Technologies, Inc. · NCT04855630
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 55–80 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 60
- US sites recruiting
- 1
- Study start
- March 1, 2023
- Record last updated
- September 23, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The Combating Alzheimer's through Sleep and Exercise (CASE) study is an exploratory, hypothesis-generating trial designed to: (1) assess whether improvements in sleep are associated with improvements in cognitive performance and cardiovascular and metabolic health; (2) evaluate the effects of structured, moderate-level aerobic and anaerobic exercise on cognitive performance and cardiovascular and metabolic health; (3) examine the combined, potentially synergistic effects of both interventions on cognitive performance and cardiovascular and metabolic health; and (4) investigate the role of light exposure as a potential modulator of sleep parameters.
Being studied: Elemind Neuromodulation Headband; Exercise Routine
Conditions: Dementia; Mild Cognitive Impairment (MCI); Cognitively Unimpaired; Alzheimer's Dementia (AD)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Aged 55-80 years at the time of the screening visit
- Able to ambulate safely and independently
- Able to safely perform moderate-intensity exercise as per the Physical Activity Readiness Questionnaire (PAR-Q, a validated exercise readiness questionnaire)
- Able to wear and use Fitbit wristwatch and/or the Elemind Neuromodulation headband and Lys devices
- Able to operate a digital device like mobile phone or computer
- Able and willing to provide venous blood samples
- Able to understand and speak English (our AR-based MCI diagnosis tool does not yet have capacity for other languages)
- Able to self-report a history of cognitive changes or impairment
- Be cognitively able (including those with and without MCI) and willing to provide informed consent
- Body weight \<400 pounds (\<181.4kg) in order to safely operate the NuStep T4r Recumbent Stepper stationary bicycle
Exclusion Criteria
- Severe mobility limitations that prevent safe participation in moderate exercise protocols
- 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
- Inability to complete intake screening procedures
- 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
- Determined to have Alzheimer's/dementia based on performance on the Quick Mild Cognitive Impairment (QMCI).
- Inability or unwillingness to learn or engage with digital devices (e.g., smartphone, Fitbit, Elemind, or Lys), even with staff support
- 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
- 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
- Current usage of disease-modifying therapy targeting amyloid (e.g., anti-amyloid monoclonal antibodies) or tau
- Body weight ≥400 pounds (≥181.4kg), which would pose a safety risk during the operation of the NuStep recumbent stationary bicycle
Recruiting US locations
University of Miami Hospitals
Miami, FL 33136
Site contact: Debbie Chung, PhD · 3052431301 · dxc1729@miami.edu
Study contacts (from the official record)
- Azizi A Seixas, PhD · 3052431301 · Azizi.seixas@med.miami.edu
- Debbie Chung, PhD · 3052431301 · dxc1729@miami.edu
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