{ "data": { "asOf": "2026-10-30T22:25:44.268Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT04855630", "title": "Combating Alzheimer's Through Sleep and Exercise", "scientificTitle": "Combating Alzheimer's Through Sleep and Exercise (CASE)", "status": "recruiting", "studyType": "interventional", "phase": [], "conditions": [ "Dementia", "Mild Cognitive Impairment (MCI)", "Cognitively Unimpaired", "Alzheimer's Dementia (AD)" ], "interventions": [ { "name": "Elemind Neuromodulation Headband", "type": "DEVICE", "description": "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." }, { "name": "Exercise Routine", "type": "OTHER", "description": "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." } ], "sponsor": { "name": "University of Miami", "type": "OTHER" }, "locations": [ { "city": "Miami", "country": "United States", "facility": "University of Miami Hospitals" } ], "outcomes": { "other": [ "Light Exposure", "Psychosocial Metrics" ], "primary": [ "Glycated Hemoglobin (HbA1c) Levels", "Total Cholesterol Levels", "Triglycerides Levels", "High-sensitivity C-reactive protein (hs-CRP) Levels", "Low-Density Lipoprotein (LDL) Levels", "C-Peptides", "High-Density Lipoprotein (HDL) Levels", "Cognitive Function", "Insulin Levels", "Neurofilament light chain" ], "secondary": [ "Total Sleep Duration", "Slow Wave Sleep Duration", "%Slow-wave Sleep", "Rapid Eye Movement Duration", "%REM", "Light Non-Rapid Eye Movement Duration", "%Light Non-Rapid Eye Movement Sleep", "Sleep Efficiency", "Sleep Onset Latency", "Restlessness (Restless Bouts/Hour during Sleep)" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n1. Aged 55-80 years at the time of the screening visit\n2. Able to ambulate safely and independently\n3. Able to safely perform moderate-intensity exercise as per the Physical Activity Readiness Questionnaire (PAR-Q, a validated exercise readiness questionnaire)\n4. Able to wear and use Fitbit wristwatch and/or the Elemind Neuromodulation headband and Lys devices\n5. Able to operate a digital device like mobile phone or computer\n6. Able and willing to provide venous blood samples\n7. Able to understand and speak English (our AR-based MCI diagnosis tool does not yet have capacity for other languages)\n8. Able to self-report a history of cognitive changes or impairment\n9. Be cognitively able (including those with and without MCI) and willing to provide informed consent\n10. Body weight \\<400 pounds (\\<181.4kg) in order to safely operate the NuStep T4r Recumbent Stepper stationary bicycle\n\nExclusion Criteria:\n\n1. Severe mobility limitations that prevent safe participation in moderate exercise protocols\n2. 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\n3. Inability to complete intake screening procedures\n4. 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\n5. Determined to have Alzheimer's/dementia based on performance on the Quick Mild Cognitive Impairment (QMCI).\n6. Inability or unwillingness to learn or engage with digital devices (e.g., smartphone, Fitbit, Elemind, or Lys), even with staff support\n7. 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\n8. 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\n9. Current usage of disease-modifying therapy targeting amyloid (e.g., anti-amyloid monoclonal antibodies) or tau\n10. Body weight ≥400 pounds (≥181.4kg), which would pose a safety risk during the operation of the NuStep recumbent stationary bicycle", "maximumAge": "80 Years", "minimumAge": "55 Years", "healthyVolunteers": true }, "enrollment": { "type": "ESTIMATED", "count": 60 }, "startDate": "2023-03-01", "completionDate": "2028-12-30", "lastUpdated": "2026-10-27T00:00:00.000Z", "firstPosted": "2021-04-22T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT04855630" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT04855630", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT04855630", "sourceUrl": "https://clinicaltrials.gov/study/NCT04855630", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-28T04:32:50.760Z", "payloadSha256": "2410ac5d99e87f7ebbf62b4889c308e7ae031cac9d18422c18f887273e418336", "piiRedacted": true } ], "citation": { "canonicalId": "NCT04855630", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT04855630", "verifyAt": "https://clinicaltrials.gov/study/NCT04855630", "retrievedAt": "2026-10-28T04:32:50.760Z", "payloadSha256": "2410ac5d99e87f7ebbf62b4889c308e7ae031cac9d18422c18f887273e418336", "text": "ClinicalTrials.gov, record NCT04855630 (https://clinicaltrials.gov/study/NCT04855630), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT04855630, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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