Combating Alzheimer's Through Sleep and Exercise
Part of paid clinical trials in Miami, Florida.
- Sponsor
- University of Miami
- Study ID
- NCT04855630
- Status
- Recruiting
Conditions
- Alzheimer Disease
- Dementia
Eligibility Criteria
- Sex
- ALL
- Age
- 45 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- DREEM 2 Headband — DEVICEParticipants 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).
- Exercise Routine — OTHERParticipants will partake in a guided exercise routine. Each routine consists of 30-minute mild circuit training session twice per week for 3 months.
Study Details
The purpose of this research is to see how sleep and exercise affects dementia risk over time.
Key Dates
- Start date
- Mar 1, 2023
- Status verified
- Apr 2026
- Primary completion
- Dec 30, 2028
- Completion
- Dec 30, 2028
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Sleep Only GroupParticipants in this group will wear the DREEM 2 headband for 12 weeks.
- Active Comparator: Exercise Only GroupParticipants in this group will workout twice a week for 12 weeks.
- Active Comparator: Exercise and Sleep GroupParticipants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks.
Primary Outcome Measure
Total Cholesterol Levels [ Time Frame: Up to Week 12 ]
Central Contacts
- Azizi A Seixas, PhD3052431301
- Debbie Chung, PhD3052431301
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami Hospitals | Miami | Florida | 33136 | Azizi A Seixas, PhD (PRINCIPAL_INVESTIGATOR) Debbie Chung, PhD (SUB_INVESTIGATOR) Alberto Ramos, MD (SUB_INVESTIGATOR) |
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