Combating Alzheimer's Through Sleep and Exercise (CASE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- High-sensitivity C-reactive protein (hs-CRP) Levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Exercise Only Group
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).
干预措施: Exercise Routine (Other)
Exercise and Sleep Group
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.
干预措施: Exercise Routine (Other)
Sleep Only Group
Participants in this group will wear the Elemind headband 3-4 times weekly for 8 weeks.
干预措施: Elemind Neuromodulation Headband (Device)
Exercise and Sleep Group
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.
干预措施: Elemind Neuromodulation Headband (Device)
结局指标
主要结局
High-sensitivity C-reactive protein (hs-CRP) Levels
时间窗: Up to Week 8
Measured from blood sample
Glycated Hemoglobin (HbA1c) Levels
时间窗: Up to Week 8
Measured from blood sample
Total Cholesterol Levels
时间窗: Up to Week 8
Measured from blood sample
Triglycerides Levels
时间窗: Up to Week 8
Measured from blood sample
Low-Density Lipoprotein (LDL) Levels
时间窗: Up to Week 8
Measured from blood sample
C-Peptides
时间窗: Up to Week 8
Measured from blood sample
High-Density Lipoprotein (HDL) Levels
时间窗: Up to Week 8
Measured from blood sample
Cognitive Function
时间窗: Up to 8 weeks
Cognitive function gauged from Altoida's Digital Neuro-Signatures
Insulin Levels
时间窗: Up to 8 weeks
Measured from blood sample
Neurofilament light chain
时间窗: Up to Week 8
Measured from blood sample
次要结局
- Total Sleep Duration(Up to Week 8)
- Slow Wave Sleep Duration(Up to Week 8)
- %Slow-wave Sleep(Up to Week 8)
- Rapid Eye Movement Duration(Up to Week 8)
- %REM(Up to Week 8)
- Light Non-Rapid Eye Movement Duration(Up to Week 8)
- %Light Non-Rapid Eye Movement Sleep(Up to Week 8)
- Sleep Efficiency(Up to Week 8)
- Sleep Onset Latency(Up to Week 8)
- Restlessness (Restless Bouts/Hour during Sleep)(Up to Week 8)
研究者
Azizi Seixas
Professor
University of Miami