Alzheimer Disease, Dementia
Conditions
Brief summary
The purpose of this research is to see how sleep and exercise affects dementia risk over time.
Interventions
DEVICEDREEM 2 Headband
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).
OTHERExercise Routine
Participants will partake in a guided exercise routine. Each routine consists of 30-minute mild circuit training session twice per week for 3 months.
Sponsors
University of Miami
Shipley Foundation
Dreem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Able to perform mild exercise 2. Able to wear DREEM 2 Headband 3. Able to wear a Fitbit wrist watch 4. Able to perform the Everlywell biomarker procedure 5. Able to Understand and Speak English 6. Able to operate a digital device like mobile phone, iPad, or computer 7. Self-reported history of problems with cognitive impairment: memory, concentration, and processing information 8. Only participants cognitively able and willing to provide consent will be included.
Exclusion criteria
1. Prohibited from or unable to perform mild exercise 2. Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason 3. Unable to speak or understand English 4. Unable to use mobile device/smartphone technology 5. Unable or unwilling to consent for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Cholesterol Levels | Up to Week 12 | Measured from blood sample |
| High-Density Lipoprotein (HDL) Levels | Up to Week 12 | Measured from blood sample |
| Low-Density Lipoprotein (LDL) Levels | Up to Week 12 | Measured from blood sample |
| Triglycerides Levels | Up to Week 12 | Measured from blood sample |
| High-sensitivity C-reactive protein (hs-CRP) Levels | Up to Week 12 | Measured from blood sample |
| HbA1c Levels | Up to Week 12 | Measured from blood sample |
| Heart Rate | Up to Week 12 | Measured from Fitbit |
| Blood Pressure | Up to Week 12 | Measured from Fitbit |
| Total Sleep Duration | Up to Week 12 | Measured from DREEM 2 |
| Slow Wave Sleep Duration | Up to Week 12 | Measured from DREEM 2 |
| Cortisol Levels | Up to Week 12 | Measured from Urine Sample |
| Cortisone Levels | Up to Week 12 | Measured from Urine Sample |
| Melatonin Levels | Up to Week 12 | Measured from Urine Sample |
| Creatinine Levels | Up to Week 12 | Measured from Urine Sample |
Countries
United States
Contacts
CONTACTAzizi A Seixas, PhD
CONTACTDebbie Chung, PhD
PRINCIPAL_INVESTIGATORAzizi A Seixas, PhD
University of Miami
Outcome results
None listed