Combating Alzheimer's Through Sleep and Exercise

Not Applicable

Recruiting

• Conditions: Dementia; Alzheimer Disease
• Interventions: Device: DREEM 2 Headband; Other: Exercise Routine

• Registration Number: NCT04855630
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-22
• Study Start: 2023-03-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Only Group	DREEM 2 Headband	Participants in this group will wear the DREEM 2 headband for 12 weeks.
Exercise Only Group	Exercise Routine	Participants in this group will workout twice a week for 12 weeks.
Exercise and Sleep Group	Exercise Routine	Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks.
Exercise and Sleep Group	DREEM 2 Headband	Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Creatinine Levels	Up to Week 12	Measured from Urine Sample
Triglycerides Levels	Up to Week 12	Measured from blood sample
High-Density Lipoprotein (HDL) Levels	Up to Week 12	Measured from blood sample
Blood Pressure	Up to Week 12	Measured from Fitbit
Cortisone Levels	Up to Week 12	Measured from Urine Sample
HbA1c Levels	Up to Week 12	Measured from blood sample
Heart Rate	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
Total Cholesterol Levels	Up to Week 12	Measured from blood sample
Low-Density Lipoprotein (LDL) 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
Cortisol Levels	Up to Week 12	Measured from Urine Sample
Melatonin Levels	Up to Week 12	Measured from Urine Sample

Trial Locations

Locations (1)

University of Miami Hospitals; 🇺🇸 Miami, Florida, United States