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Combating Alzheimer's Through Sleep and Exercise

University of Miami · with Shipley Foundation, Elemind Technologies, Inc. · NCT04855630

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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
All sleep studies in Florida →
Combating Alzheimer's Through Sleep and Exercise (NCT04855630) | Bored Studies