Combating Alzheimer's Through Sleep and Exercise

NCT04855630 | Recruiting

• 2 other identifiers: 2022093120-01023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Sleep; Exercise; Clinical Trial; Cognition; Cardiometabolic Health; Brain Health; Mild Cognitive Impairment; Alzheimer's Disease; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (10)

• Glycated Hemoglobin (HbA1c) Levels

  Measured from blood sample

  Up to Week 8

• Total Cholesterol Levels

  Measured from blood sample

  Up to Week 8

• Triglycerides Levels

  Measured from blood sample

  Up to Week 8

• High-sensitivity C-reactive protein (hs-CRP) Levels

  Measured from blood sample

  Up to Week 8

• Low-Density Lipoprotein (LDL) Levels

  Measured from blood sample

  Up to Week 8

• C-Peptides

  Measured from blood sample

  Up to Week 8

• High-Density Lipoprotein (HDL) Levels

  Measured from blood sample

  Up to Week 8

• Cognitive Function

  Cognitive function gauged from Altoida's Digital Neuro-Signatures

  Up to 8 weeks

• Insulin Levels

  Measured from blood sample

  Up to 8 weeks

• Neurofilament light chain

  Measured from blood sample

  Up to Week 8

Secondary Outcomes (10)

• Total Sleep Duration

  Up to Week 8

• Slow Wave Sleep Duration

  Up to Week 8

• %Slow-wave Sleep

  Up to Week 8

• Rapid Eye Movement Duration

  Up to Week 8

• %REM

  Up to Week 8

Other Outcomes (2)

• Light Exposure

  Up to Week 8

• Psychosocial Metrics

  Up to Week 8

Study Arms (3)

Sleep Only Group

EXPERIMENTAL

Participants in this group will wear the Elemind headband 3-4 times weekly for 8 weeks.

Device: Elemind Neuromodulation Headband

Exercise Only Group

ACTIVE COMPARATOR

Participants in this group will participate in a structured, on-site, twice a week exercise program for 60 minutes/session for 8 weeks (16 total sessions). Each exercise session is comprised of 60 minutes, including 10 minutes of warm-up, 20 minutes of cardiovascular exercise on a stationary bike, 20 minutes of resistance training (1 day of upper body focus, 1 day of lower body focus each week), and 10 minutes of cooling off).

Other: Exercise Routine

Exercise and Sleep Group

ACTIVE COMPARATOR

Participants in this group will take part in the on-site, structured exercise program twice per week for 8 weeks in additional to wearing the Elemind headband 3-4 times per week for 8 weeks.

Device: Elemind Neuromodulation Headband; Other: Exercise Routine

Interventions

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.

Exercise Only Group; Exercise and Sleep Group

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 and Sleep Group; Sleep Only Group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe mobility limitations that prevent safe participation in moderate exercise protocols
• 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
• Inability to complete intake screening procedures
• 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).
• 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
• Current usage of disease-modifying therapy targeting amyloid (e.g., anti-amyloid monoclonal antibodies) or tau
• Body weight ≥400 pounds (≥181.4kg), which would pose a safety risk during the operation of the NuStep recumbent stationary bicycle

Sponsors & Collaborators

• University of Miami: lead
• Shipley Foundation: collaborator
• Elemind Technologies, Inc.: collaborator
• Fitbit LLC: collaborator
• Altoida: collaborator

Study Sites (1)

University of Miami Hospitals

Miami, Florida, 33136, United States

RECRUITING

Related Publications (1)

• Chung D, Larsen BA, Garchitorena Gomez LG, Ramos AR, Kirk-Sanchez NJ, Jean-Louis G, Seixas AA. Combating Alzheimer's through sleep and exercise (CASE): A study protocol. Geroscience. 2026 Jun 6. doi: 10.1007/s11357-026-02337-1. Online ahead of print.

  PMID: 42249253 DERIVED

Related Links

• Combating Alzheimer's through sleep and exercise (CASE): A study protocol

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Alzheimer Disease; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Azizi A Seixas, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azizi A Seixas, PhD

CONTACT

3052431301; Azizi.seixas@med.miami.edu

Debbie Chung, PhD

CONTACT

3052431301; dxc1729@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)