RECRUITING Not applicable ClinicalTrials.gov

Combating Alzheimer's Through Sleep and Exercise

Sponsor: University of Miami • ClinicalTrials.gov ID: NCT04855630

Registry updated: 2026-09-23

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Description

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.

Interventions

Elemind Neuromodulation Headband (Device)
The Elemind Neuromodulation headband is a wearable device that utilizes noninvasive, electroencephalography-based (EEG-based) technology to induce a sleep state more rapidly via personalized acoustic stimulation. Specifically, the headband uses a closed-loop system, meaning that the headband conveys stimulation based upon recorded neural activity in order to modulate real-time oscillating circuits at the macroscopic level. This device uses five dry, flexible EEG electrodes-including three recording electrodes that are positioned at the Fpz and Fp1/2 electrode sites in accordance with the 10-20 International System of electrode placement and two silicone rubber-based, linked reference electrodes located at the mastoids-to measure neural activity during sleep and provide an estimation of the phases of real-time neural oscillations. The headband generates a sound pulse by identifying alpha neural oscillations in real-time through endpoint-corrected Hilbert Transform algorithm.
Exercise Routine (Other)
Participants randomized to the exercise-only group will engage in an 8-week, home- and site-based exercise intervention designed for older adults across a range of cognitive and physical function levels. All site-based sessions will occur in-person at the study facility under supervision of trained staff. Each week, participants will attend two 60-minute structured exercise sessions, consisting of aerobic training and resistance training. On the remaining five days when subjects will not engage in structured exercise, subjects will be asked to engage in 30 minutes of moderate-intensity walking activities. In-lab exercise protocols will be fully standardized to ensure consistency of exercise dosage and fidelity across participants. The target exercise load will be 270 minutes of moderate-intensity exercise weekly for 8 weeks.

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

Conditions

Dementia Mild Cognitive Impairment (MCI) Cognitively Unimpaired Alzheimer's Dementia (AD)

Locations

University of Miami Hospitals — Miami, Florida, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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