NCT04855630 · University of Miami
Combating Alzheimer's Through Sleep and Exercise
(CASE)
What this study is about
The purpose of this research is to see how sleep and exercise affects dementia risk over time.
View original scientific description
The purpose of this research is to see how sleep and exercise affects dementia risk over time.
Interventions
DEVICE
Elemind Neuromodulation Headband
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.
OTHER
Exercise Routine
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.
Primary outcome measures
Glycated Hemoglobin (HbA1c) Levels
Time frame: Up to Week 8
Measured from blood sample
Total Cholesterol Levels
Time frame: Up to Week 8
Measured from blood sample
Triglycerides Levels
Time frame: Up to Week 8
Measured from blood sample
High-sensitivity C-reactive protein (hs-CRP) Levels
Time frame: Up to Week 8
Measured from blood sample
Low-Density Lipoprotein (LDL) Levels
Time frame: Up to Week 8
Measured from blood sample
C-Peptides
Time frame: Up to Week 8
Measured from blood sample
High-Density Lipoprotein (HDL) Levels
Time frame: Up to Week 8
Measured from blood sample
Cognitive Function
Time frame: Up to 8 weeks
Cognitive function gauged from Altoida's Digital Neuro-Signatures
Insulin Levels
Time frame: Up to 8 weeks
Measured from blood sample
Neurofilament light chain
Time frame: Up to Week 8
Measured from blood sample
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Able to perform mild exercise
- Able to wear DREEM 2 Headband
- Able to wear a Fitbit wrist watch
- Able to perform the Everlywell biomarker procedure
- Able to Understand and Speak English
- Able to operate a digital device like mobile phone, iPad, or computer
- Self-reported history of problems with cognitive impairment: memory, concentration, and processing information
- Only participants cognitively able and willing to provide consent will be included.
Exclusion criteria
- Prohibited from or unable to perform mild exercise
- Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason
- Unable to speak or understand English
- Unable to use mobile device/smartphone technology
- Unable or unwilling to consent for any reason.
Where
- Miami, Florida
Collaborators
Shipley Foundation, Elemind Technologies, Inc., Fitbit LLC, Altoida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2026 · Source of record for eligibility and locations