Combating Alzheimer's Through Sleep and Exercise

NCT ID
NCT04855630
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
University of Miami
Conditions
Alzheimer's Dementia (AD), Cognitively Unimpaired, Dementia, Mild Cognitive Impairment (MCI)

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Combating Alzheimer's Through Sleep and Exercise (CASE)

Enrollment: 60 participants (Estimated).

What is being studied

  • Device: Elemind Neuromodulation Headband
  • Other: Exercise Routine

Who may be eligible

Ages
55 Years to 80 Years
Sex
All
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following 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 locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Florida, United States: 1

Sample of listed locations

  • University of Miami Hospitals — Miami, Florida, 33136, United States — Recruiting

Study details

Start date
March 1, 2023
Primary completion date
December 30, 2028
Completion date
December 30, 2028
First posted
April 22, 2021
Collaborators
Altoida, Elemind Technologies, Inc., Fitbit LLC, Shipley Foundation

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT04855630
Registry last updated
September 23, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT04855630 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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