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| ID | Type | Description | Link |
|---|---|---|---|
| 20-01023 | Other Identifier | NYU |
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| Name | Class |
|---|---|
| Shipley Foundation | UNKNOWN |
| Dreem | INDUSTRY |
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The purpose of this research is to see how sleep and exercise affects dementia risk over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Only Group | Experimental | Participants in this group will wear the DREEM 2 headband for 12 weeks. |
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| Exercise Only Group | Active Comparator | Participants in this group will workout twice a week for 12 weeks. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DREEM 2 Headband | Device | 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Azizi A Seixas, PhD | Contact | 3052431301 | Azizi.seixas@med.miami.edu | |
| Debbie Chung, PhD | Contact | 3052431301 | dxc1729@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Azizi A Seixas, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Hospitals | Recruiting | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42249253 | Derived | Chung D, Larsen BA, Garchitorena Gomez LG, Ramos AR, Kirk-Sanchez NJ, Jean-Louis G, Seixas AA. Combating Alzheimer's through sleep and exercise (CASE): A study protocol. Geroscience. 2026 Jun 6. doi: 10.1007/s11357-026-02337-1. Online ahead of print. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| Exercise Routine | Other | Participants will partake in a guided exercise routine. Each routine consists of 30-minute mild circuit training session twice per week for 3 months. |
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| 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 |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |