Combating Alzheimer's Through Sleep and Exercise

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

Official Title
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Combating Alzheimer's Through Sleep and Exercise (CASE)

Conditions
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Alzheimer Disease, Dementia

Intervention / Treatment
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* Device: DREEM 2 Headband
* Other: Exercise Routine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Only Group<br>Participants in this group will wear the DREEM 2 headband for 12 weeks. | Device: DREEM 2 Headband<br>* Participants will wear the DREEM 2 headband for 3 months for a minimum of 4 out of 7 nights per week and will participate in its digital therapeutic Cognitive Behavioral Therapy - Insomnia (CBT-I) intervention (entails brain stimulation to improve slow wave sleep and sleep hygiene counseling tips to improve sleep behaviors).<br>|
| Active Comparator: Exercise Only Group<br>Participants in this group will workout twice a week for 12 weeks. | Other: Exercise Routine<br>* Participants will partake in a guided exercise routine. Each routine consists of 30-minute mild circuit training session twice per week for 3 months.<br>|
| Active Comparator: Exercise and Sleep Group<br>Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks. | Device: DREEM 2 Headband<br>* Participants will wear the DREEM 2 headband for 3 months for a minimum of 4 out of 7 nights per week and will participate in its digital therapeutic Cognitive Behavioral Therapy - Insomnia (CBT-I) intervention (entails brain stimulation to improve slow wave sleep and sleep hygiene counseling tips to improve sleep behaviors).<br>Other: Exercise Routine<br>* Participants will partake in a guided exercise routine. Each routine consists of 30-minute mild circuit training session twice per week for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol Levels | Measured from blood sample | Up to Week 12 | 
| High-Density Lipoprotein (HDL) Levels | Measured from blood sample | Up to Week 12 | 
| Low-Density Lipoprotein (LDL) Levels | Measured from blood sample | Up to Week 12 | 
| Triglycerides Levels | Measured from blood sample | Up to Week 12 | 
| High-sensitivity C-reactive protein (hs-CRP) Levels | Measured from blood sample | Up to Week 12 | 
| HbA1c Levels | Measured from blood sample | Up to Week 12 | 
| Heart Rate | Measured from Fitbit | Up to Week 12 | 
| Blood Pressure | Measured from Fitbit | Up to Week 12 | 
| Total Sleep Duration | Measured from DREEM 2 | Up to Week 12 | 
| Slow Wave Sleep Duration | Measured from DREEM 2 | Up to Week 12 | 
| Cortisol Levels | Measured from Urine Sample | Up to Week 12 | 
| Cortisone Levels | Measured from Urine Sample | Up to Week 12 | 
| Melatonin Levels | Measured from Urine Sample | Up to Week 12 | 
| Creatinine Levels | Measured from Urine Sample | Up to Week 12 |