Combating Alzheimer's Through Sleep and Exercise
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-80
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Elemind Neuromodulation Headband
DeviceThe 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 Routine
Other interventionParticipants 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Sleep Only GroupExperimental treatment 1 intervention
Group B: Exercise Only GroupActive comparator 1 intervention
Group C: Exercise and Sleep GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Glycated Hemoglobin (HbA1c) Levels
Measured from blood sample
Time frame
Up to Week 82
Total Cholesterol Levels
Measured from blood sample
Time frame
Up to Week 83
Triglycerides Levels
Measured from blood sample
Time frame
Up to Week 84
High-sensitivity C-reactive protein (hs-CRP) Levels
Measured from blood sample
Time frame
Up to Week 8Secondary outcomes
1
Total Sleep Duration
Measured from Elemind
Time frame
Up to Week 82
Slow Wave Sleep Duration
Measured from Elemind
Time frame
Up to Week 83
%Slow-wave Sleep
Measured by Elemind headband
Time frame
Up to Week 84
Rapid Eye Movement Duration
Measured by Elemind headband
Time frame
Up to Week 8Other outcomes
1
Light Exposure
Measured by LYS Device
Time frame
Up to Week 82
Psychosocial Metrics
Measured by Questionnaires
Time frame
Up to Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
Shipley Foundation
Collaborator
Elemind Technologies, Inc.
Collaborator
Fitbit LLC
Collaborator
Altoida
Collaborator
Source ClinicalTrials.gov