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临床试验/NCT04855630
NCT04855630招募中不适用

Combating Alzheimer's Through Sleep and Exercise (CASE)

University of Miami2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Creatinine Levels

研究概览

简要总结

The purpose of this research is to see how sleep and exercise affects dementia risk over time.

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
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to perform mild exercise
  • Able to wear DREEM 2 Headband
  • Able to wear a Fitbit wrist watch
  • Able to perform the Everlywell biomarker procedure
  • Able to Understand and Speak English
  • Able to operate a digital device like mobile phone, iPad, or computer
  • Self-reported history of problems with cognitive impairment: memory, concentration, and processing information
  • Only participants cognitively able and willing to provide consent will be included.

排除标准

  • Prohibited from or unable to perform mild exercise
  • Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason
  • Unable to speak or understand English
  • Unable to use mobile device/smartphone technology
  • Unable or unwilling to consent for any reason.

研究组 & 干预措施

Exercise and Sleep Group

Active Comparator

Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks.

干预措施: Exercise Routine (Other)

Sleep Only Group

Experimental

Participants in this group will wear the DREEM 2 headband for 12 weeks.

干预措施: DREEM 2 Headband (Device)

Exercise Only Group

Active Comparator

Participants in this group will workout twice a week for 12 weeks.

干预措施: Exercise Routine (Other)

Exercise and Sleep Group

Active Comparator

Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks.

干预措施: DREEM 2 Headband (Device)

结局指标

主要结局

Creatinine Levels

时间窗: Up to Week 12

Measured from Urine Sample

HbA1c Levels

时间窗: Up to Week 12

Measured from blood sample

Heart Rate

时间窗: Up to Week 12

Measured from Fitbit

Total Sleep Duration

时间窗: Up to Week 12

Measured from DREEM 2

Slow Wave Sleep Duration

时间窗: Up to Week 12

Measured from DREEM 2

Triglycerides Levels

时间窗: Up to Week 12

Measured from blood sample

High-Density Lipoprotein (HDL) Levels

时间窗: Up to Week 12

Measured from blood sample

Blood Pressure

时间窗: Up to Week 12

Measured from Fitbit

Cortisone Levels

时间窗: Up to Week 12

Measured from Urine Sample

Total Cholesterol Levels

时间窗: Up to Week 12

Measured from blood sample

Low-Density Lipoprotein (LDL) Levels

时间窗: Up to Week 12

Measured from blood sample

High-sensitivity C-reactive protein (hs-CRP) Levels

时间窗: Up to Week 12

Measured from blood sample

Cortisol Levels

时间窗: Up to Week 12

Measured from Urine Sample

Melatonin Levels

时间窗: Up to Week 12

Measured from Urine Sample

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Azizi Seixas

Associate Professor

University of Miami

研究点 (2)

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