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NCT04855630Recruiting

Combating Alzheimer's Through Sleep and Exercise

Combating Alzheimer's Through Sleep and Exercise (CASE)

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
19 Apr 2021
Start date
1 Mar 2023
Primary completion date
30 Dec 2028
Lead sponsor
University of Miami
NCT number
NCT04855630

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 1 Mar 2023 to the primary completion date, 30 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 55 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Miami Hospitals
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.