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Clinical Trials/NCT04855630
NCT04855630
Recruiting
Not Applicable

Combating Alzheimer's Through Sleep and Exercise (CASE)

University of Miami2 sites in 1 country30 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Exercise Routine
Conditions
Alzheimer Disease
Sponsor
University of Miami
Enrollment
30
Locations
2
Primary Endpoint
Creatinine Levels
Status
Recruiting
Last Updated
12 days ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
December 30, 2028
Last Updated
12 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Azizi Seixas

Associate Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

Exercise and Sleep Group

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

Intervention: Exercise Routine

Sleep Only Group

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

Intervention: DREEM 2 Headband

Exercise Only Group

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

Intervention: Exercise Routine

Exercise and Sleep Group

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

Intervention: DREEM 2 Headband

Outcomes

Primary Outcomes

Creatinine Levels

Time Frame: Up to Week 12

Measured from Urine Sample

HbA1c Levels

Time Frame: Up to Week 12

Measured from blood sample

Heart Rate

Time Frame: Up to Week 12

Measured from Fitbit

Total Sleep Duration

Time Frame: Up to Week 12

Measured from DREEM 2

Slow Wave Sleep Duration

Time Frame: Up to Week 12

Measured from DREEM 2

Triglycerides Levels

Time Frame: Up to Week 12

Measured from blood sample

High-Density Lipoprotein (HDL) Levels

Time Frame: Up to Week 12

Measured from blood sample

Blood Pressure

Time Frame: Up to Week 12

Measured from Fitbit

Cortisone Levels

Time Frame: Up to Week 12

Measured from Urine Sample

Total Cholesterol Levels

Time Frame: Up to Week 12

Measured from blood sample

Low-Density Lipoprotein (LDL) Levels

Time Frame: Up to Week 12

Measured from blood sample

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

Time Frame: Up to Week 12

Measured from blood sample

Cortisol Levels

Time Frame: Up to Week 12

Measured from Urine Sample

Melatonin Levels

Time Frame: Up to Week 12

Measured from Urine Sample

Study Sites (2)

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