Combating Alzheimer's Through Sleep and Exercise
NCT04855630 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-04-20
Summary
The purpose of this research is to see how sleep and exercise affects dementia risk over time.
Conditions
- Alzheimer Disease
- Dementia
Interventions
- DEVICE
-
DREEM 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).
- OTHER
-
Exercise 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 & Collaborators
-
Shipley Foundation
collaborator UNKNOWN -
Dreem
collaborator INDUSTRY -
University of Miami
lead OTHER
Principal Investigators
-
Azizi A Seixas, PhD · University of Miami
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-01
- Primary Completion
- 2028-12-30
- Completion
- 2028-12-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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