DementiaCASENCT04855630
Combating Alzheimer's Through Sleep and Exercise
A study testing Elemind Neuromodulation Headband and Exercise Routine in people with Dementia and Mild Cognitive Impairment (MCI), run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mild Cognitive Impairment (MCI), Cognitively Unimpaired
- What is being tested?
- Elemind Neuromodulation Headband and Exercise Routine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami Hospitals
Miami, Florida, 33136
Debbie Chung, PhD, 3052431301, dxc1729@miami.edu
Azizi A Seixas, PhD, 3052431301, Azizi.seixas@med.miami.edu
About this study
Official title: Combating Alzheimer's Through Sleep and Exercise (CASE)
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)
- Being tested
- Elemind Neuromodulation Headband, Exercise Routine
- Keywords
- Sleep, Exercise, Clinical Trial, Cognition, Cardiometabolic Health, Brain Health, Mild Cognitive Impairment, Alzheimer's Disease, Randomized Controlled Trial
- Medical subject headings
- Dementia, Cognitive Dysfunction, Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elemind Neuromodulation HeadbandDevice
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 RoutineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Only Group | Experimental | Participants in this group will wear the Elemind headband 3-4 times weekly for 8 weeks. Receives: 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). Receives: 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. Receives: Device: Elemind Neuromodulation Headband; Other: Exercise Routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin (HbA1c) Levels
Measured from blood sample
Measured: Up to Week 8
Total Cholesterol Levels
Measured from blood sample
Measured: Up to Week 8
Triglycerides Levels
Measured from blood sample
Measured: Up to Week 8
High-sensitivity C-reactive protein (hs-CRP) Levels
Measured from blood sample
Measured: Up to Week 8
Low-Density Lipoprotein (LDL) Levels
Measured from blood sample
Measured: Up to Week 8
C-Peptides
Measured from blood sample
Measured: Up to Week 8
High-Density Lipoprotein (HDL) Levels
Measured from blood sample
Measured: Up to Week 8
Cognitive Function
Cognitive function gauged from Altoida's Digital Neuro-Signatures
Measured: Up to 8 weeks
Insulin Levels
Measured from blood sample
Measured: Up to 8 weeks
Neurofilament light chain
Measured from blood sample
Measured: Up to Week 8
Secondary outcomes (10)
Total Sleep Duration
Measured from Elemind
Measured: Up to Week 8
Slow Wave Sleep Duration
Measured from Elemind
Measured: Up to Week 8
%Slow-wave Sleep
Measured by Elemind headband
Measured: Up to Week 8
Rapid Eye Movement Duration
Measured by Elemind headband
Measured: Up to Week 8
%REM
Measured by Elemind headband
Measured: Up to Week 8
Light Non-Rapid Eye Movement Duration
Measured by Elemind headband
Measured: Up to Week 8
%Light Non-Rapid Eye Movement Sleep
Measured by Elemind headband
Measured: Up to Week 8
Sleep Efficiency
Measured by Elemind headband
Measured: Up to Week 8
Sleep Onset Latency
Measured by Elemind headband
Measured: Up to Week 8
Restlessness (Restless Bouts/Hour during Sleep)
Measured by Elemind headband
Measured: Up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Mar 2023
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Shipley Foundation, Elemind Technologies, Inc., Fitbit LLC, Altoida
- Responsible party
- Principal investigator, Azizi Seixas, University of Miami
- Investigators
- Azizi A Seixas, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855630
- Sponsor's protocol ID
- 20220931
- Other IDs
- 20-01023
- Acronym
- CASE
- Status last verified
- Sep 2026
- First submitted
- 19 Apr 2021
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42249253
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combating Alzheimer's Through Sleep and Exercise (CASE)
- ClinicalTrials.gov ID
- NCT04855630
- Acronym / sponsor ID
- CASE / 20220931
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Shipley Foundation, Elemind Technologies, Inc., Fitbit LLC, Altoida
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sleep Only Group | Experimental | Device: Elemind Neuromodulation HeadbandParticipants in this group will wear the Elemind headband 3-4 times weekly for 8 weeks. |
| Exercise Only Group | Active comparator | Other: Exercise RoutineParticipants 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). |
| Exercise and Sleep Group | Active comparator | Device: Elemind Neuromodulation Headband, Other: Exercise RoutineParticipants 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elemind Neuromodulation HeadbandThe 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. | Device | Exercise and Sleep Group, Sleep Only Group |
| Exercise RoutineParticipants 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. | Other | Exercise Only Group, Exercise and Sleep Group |
Primary outcome
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
10 secondary outcomes
Total Sleep Duration
Time frame: Up to Week 8
Slow Wave Sleep Duration
Time frame: Up to Week 8
%Slow-wave Sleep
Time frame: Up to Week 8
Rapid Eye Movement Duration
Time frame: Up to Week 8
%REM
Time frame: Up to Week 8
Light Non-Rapid Eye Movement Duration
Time frame: Up to Week 8
%Light Non-Rapid Eye Movement Sleep
Time frame: Up to Week 8
Sleep Efficiency
Time frame: Up to Week 8
Sleep Onset Latency
Time frame: Up to Week 8
Restlessness (Restless Bouts/Hour during Sleep)
Time frame: Up to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Derived from this study: PubMed 42249253Chung 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.
- Combating Alzheimer's through sleep and exercise (CASE): A study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Azizi A Seixas, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elemind Neuromodulation Headband and Exercise Routine in people with Dementia and Mild Cognitive Impairment (MCI), run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Azizi A Seixas, PhD (3052431301, Azizi.seixas@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Hemoglobin (HbA1c) Levels (time frame: Up to Week 8). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04855630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.