An interventional study of Elemind Neuromodulation Headband and Exercise Routine in Dementia, Mild Cognitive Impairment (MCI) and Cognitively Unimpaired, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 55 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by University of Miami · Not applicable, Interventional, and Prevention
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.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will wear the Elemind headband 3-4 times weekly for 8 weeks.
Device: Elemind Neuromodulation Headband
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
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
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.
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.
Glycated Hemoglobin (HbA1c) Levels
Measured from blood sample
Time frame: Up to Week 8
Total Cholesterol Levels
Measured from blood sample
Time frame: Up to Week 8
Triglycerides Levels
Measured from blood sample
Time frame: Up to Week 8
High-sensitivity C-reactive protein (hs-CRP) Levels
Measured from blood sample
Time frame: Up to Week 8
Low-Density Lipoprotein (LDL) Levels
Measured from blood sample
Time frame: Up to Week 8
C-Peptides
Measured from blood sample
Time frame: Up to Week 8
High-Density Lipoprotein (HDL) Levels
Measured from blood sample
Time frame: Up to Week 8
Cognitive Function
Cognitive function gauged from Altoida's Digital Neuro-Signatures
Time frame: Up to 8 weeks
Insulin Levels
Measured from blood sample
Time frame: Up to 8 weeks
Neurofilament light chain
Measured from blood sample
Time frame: Up to Week 8
Total Sleep Duration
Measured from Elemind
Time frame: Up to Week 8
Slow Wave Sleep Duration
Measured from Elemind
Time frame: Up to Week 8
%Slow-wave Sleep
Measured by Elemind headband
Time frame: Up to Week 8
Rapid Eye Movement Duration
Measured by Elemind headband
Time frame: Up to Week 8
%REM
Measured by Elemind headband
Time frame: Up to Week 8
Light Non-Rapid Eye Movement Duration
Measured by Elemind headband
Time frame: Up to Week 8
%Light Non-Rapid Eye Movement Sleep
Measured by Elemind headband
Time frame: Up to Week 8
Sleep Efficiency
Measured by Elemind headband
Time frame: Up to Week 8
Sleep Onset Latency
Measured by Elemind headband
Time frame: Up to Week 8
Restlessness (Restless Bouts/Hour during Sleep)
Measured by Elemind headband
Time frame: Up to Week 8
Light Exposure
Measured by LYS Device
Time frame: Up to Week 8
Psychosocial Metrics
Measured by Questionnaires
Time frame: Up to Week 8
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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