Combating Alzheimer's Through Sleep and Exercise

Alzheimer Disease Clinical Trial

— CASE  

Official title:

Combating Alzheimer's Through Sleep and Exercise (CASE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04855630
• Other study ID #: 20220931
• Secondary ID: 20-01023
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Azizi A Seixas, PhD
• Phone: 3052431301
• Email: Azizi.seixas[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami Hospitals	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	Dreem, Shipley Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Cholesterol Levels	Measured from blood sample	Up to Week 12
Primary	High-Density Lipoprotein (HDL) Levels	Measured from blood sample	Up to Week 12
Primary	Low-Density Lipoprotein (LDL) Levels	Measured from blood sample	Up to Week 12
Primary	Triglycerides Levels	Measured from blood sample	Up to Week 12
Primary	High-sensitivity C-reactive protein (hs-CRP) Levels	Measured from blood sample	Up to Week 12
Primary	HbA1c Levels	Measured from blood sample	Up to Week 12
Primary	Heart Rate	Measured from Fitbit	Up to Week 12
Primary	Blood Pressure	Measured from Fitbit	Up to Week 12
Primary	Total Sleep Duration	Measured from DREEM 2	Up to Week 12
Primary	Slow Wave Sleep Duration	Measured from DREEM 2	Up to Week 12
Primary	Cortisol Levels	Measured from Urine Sample	Up to Week 12
Primary	Cortisone Levels	Measured from Urine Sample	Up to Week 12
Primary	Melatonin Levels	Measured from Urine Sample	Up to Week 12
Primary	Creatinine Levels	Measured from Urine Sample	Up to Week 12