Combating Alzheimer's Through Sleep and Exercise (CASE)

University of Miami

Status: Enrolling

Conditions: Alzheimer Disease; Dementia

Treatments: Device: DREEM 2 Headband; Other: Exercise Routine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04855630

20-01023

20220931

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Sleep Only Group

Experimental group

Description:

Participants in this group will wear the DREEM 2 headband for 12 weeks.

Treatment:

Device: DREEM 2 Headband

Exercise Only Group

Active Comparator group

Description:

Participants in this group will workout twice a week for 12 weeks.

Treatment:

Other: Exercise Routine

Exercise and Sleep Group

Active Comparator group

Description:

Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks.

Treatment:

Other: Exercise Routine

Device: DREEM 2 Headband