Combating Alzheimer's Through Sleep and Exercise
Combating Alzheimer's Through Sleep and Exercise (CASE)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 55 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether better sleep, moderate exercise, or both may improve thinking, heart health, and how the body uses energy. It also looks at how light exposure may affect sleep. It is for adults ages 55–80 who report changes in thinking or memory and can safely exercise.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 55–80 years old at the screening visit.
- Be able to walk safely without help and do moderate exercise safely, based on an exercise safety questionnaire.
- Be able to use a phone or computer and wear and use the study devices, such as a Fitbit watch, Elemind headband, and/or Lys devices.
- Be able and willing to give blood samples drawn from a vein.
- Be able to understand and speak English.
- Be able to report past changes or problems with your thinking or memory.
- Be able to understand the study and agree to join. People with or without mild cognitive impairment (mild thinking or memory problems) may qualify.
- Weigh less than 400 pounds (181.4 kilograms) to safely use the study exercise bike.
Who can't join
- Have major trouble moving that makes exercise unsafe, or weigh 400 pounds (181.4 kilograms) or more.
- Have an unstable or uncontrolled health problem that makes participation unsafe, such as a heart-related event, stroke, or mini-stroke within the past 6 months, active cancer, or uncontrolled diabetes.
- Be unable to finish screening, or have severe hearing loss that is not corrected or vision problems that interfere with using devices or following exercise guidance.
- Have results on the Quick Mild Cognitive Impairment test that indicate Alzheimer's disease or dementia.
- Be unable or unwilling to learn or use digital devices, even with staff help.
- Already do at least 150 minutes of moderate exercise and/or 75 minutes of hard exercise per week, based on Fitbit data during the first 7 days of screening.
- Already have enough sleep, defined as being asleep for an average of at least 80% of time in bed, based on headband data during the first 7 days of screening.
- Currently take treatment meant to change the course of disease by targeting amyloid or tau, proteins linked to Alzheimer's disease.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 sites (1)
FL
- University of Miami Hospitals · Miami, FL 33136Debbie Chung, PhD · Study contact · 3052431301 · dxc1729@miami.eduAzizi A Seixas, PhD · Study contact · 3052431301 · Azizi.seixas@med.miami.eduAzizi A Seixas, PhD · Principal investigatorDebbie Chung, PhD · Sub-investigatorMore trials in Miami