Combating Alzheimer's Through Sleep and Exercise (CASE)

Combating Alzheimer's Through Sleep and Exercise (CASE)

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

Study Overview

• Status: Recruiting
• Conditions: Dementia; Alzheimer Disease
• Intervention / Treatment: Device: DREEM 2 Headband; Other: Exercise Routine

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Azizi A Seixas, PhD; Phone Number: 3052431301; Email: Azizi.seixas@med.miami.edu
• Study Contact Backup: Name: Debbie Chung, PhD; Phone Number: 3052431301; Email: dxc1729@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Hospitals
      • Contact: Azizi A Seixas, PhD; Phone Number: 3052431301; Email: Azizi.seixas@med.miami.edu
      • Principal Investigator: Azizi A Seixas, PhD
      • Sub-Investigator: Alberto Ramos, MD
      • Contact: Debbie Chung, PhD; Phone Number: 3052431301; Email: dxc1729@miami.edu
      • Sub-Investigator: Debbie Chung, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Only Group; Participants in this group will wear the DREEM 2 headband for 12 weeks.	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).
Active Comparator: Exercise Only Group; Participants in this group will workout twice a week for 12 weeks.	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.
Active Comparator: Exercise and Sleep Group; Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Shipley Foundation; Dreem
• Investigators: Principal Investigator: Azizi A Seixas, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: 20220931; 20-01023 (Other Identifier: NYU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No