Testing a sleep headband and exercise in adults with memory problems or Alzheimer's
Tests a sleep headband and an exercise routine in adults aged 55 to 80.
Plain-language title generated from the registry record
Registry title: Combating Alzheimer's Through Sleep and Exercise
Key facts
- Where
- Miami, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 80 years old?
Source: NCT04855630, who can take part
Where in United States
- University of Miami HospitalsMiami, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Miami
- Trial code
- NCT04855630
- Record updated
- 27 October 2026
- Original 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.Read full original descriptionShow less
Combating Alzheimer's Through Sleep and Exercise (CASE)
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.
Inclusion: 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: 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; 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); Current usage of disease-modifying therapy targeting amyloid (e.g., anti-amyloid monoclonal antibodies) or tau; Severe mobility limitations that prevent safe participation in moderate exercise protocols; Inability to complete intake screening procedures; 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; Body weight ≥400 pounds (≥181.4kg), which would pose a safety risk during the operation of the NuStep recumbent stationary bicycle.