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Combating Alzheimer's Through Sleep and Exercise (CASE)

Primary Purpose

Alzheimer Disease, Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DREEM 2 Headband
Exercise Routine
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 45 years and older
  2. Able to perform mild exercise
  3. Able to wear DREEM 2 Headband
  4. Able to wear a Fitbit wrist watch
  5. Able to perform the Everlywell biomarker procedure
  6. Able to Understand and Speak English
  7. Able to operate a digital device like mobile phone, iPad, or computer
  8. Self-reported history of problems with cognitive impairment: memory, concentration, and processing information
  9. Only participants cognitively able and willing to provide consent will be included.

Exclusion Criteria:

  1. Under 45 years old
  2. Prohibited from or unable to perform mild exercise
  3. Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason
  4. Unable to speak or understand English
  5. Unable to use mobile device/smartphone technology
  6. Unable or unwilling to consent for any reason.

Sites / Locations

  • University of Miami HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Sleep Only Group

Exercise Only Group

Exercise and Sleep Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Total Cholesterol Levels
Measured from blood sample
High-Density Lipoprotein (HDL) Levels
Measured from blood sample
Low-Density Lipoprotein (LDL) Levels
Measured from blood sample
Triglycerides Levels
Measured from blood sample
High-sensitivity C-reactive protein (hs-CRP) Levels
Measured from blood sample
HbA1c Levels
Measured from blood sample
Heart Rate
Measured from Fitbit
Blood Pressure
Measured from Fitbit
Total Sleep Duration
Measured from DREEM 2
Slow Wave Sleep Duration
Measured from DREEM 2
Cortisol Levels
Measured from Urine Sample
Cortisone Levels
Measured from Urine Sample
Melatonin Levels
Measured from Urine Sample
Creatinine Levels
Measured from Urine Sample

Secondary Outcome Measures

Full Information

First Posted
April 19, 2021
Last Updated
August 31, 2023
Sponsor
University of Miami
Collaborators
Shipley Foundation, Dreem
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1. Study Identification

Unique Protocol Identification Number
NCT04855630
Brief Title
Combating Alzheimer's Through Sleep and Exercise
Acronym
CASE
Official Title
Combating Alzheimer's Through Sleep and Exercise (CASE)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Shipley Foundation, Dreem

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep Only Group
Arm Type
Experimental
Arm Description
Participants in this group will wear the DREEM 2 headband for 12 weeks.
Arm Title
Exercise Only Group
Arm Type
Active Comparator
Arm Description
Participants in this group will workout twice a week for 12 weeks.
Arm Title
Exercise and Sleep Group
Arm Type
Active Comparator
Arm Description
Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks.
Intervention Type
Device
Intervention Name(s)
DREEM 2 Headband
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Exercise Routine
Intervention Description
Participants will partake in a guided exercise routine. Each routine consists of 30-minute mild circuit training session twice per week for 3 months.
Primary Outcome Measure Information:
Title
Total Cholesterol Levels
Description
Measured from blood sample
Time Frame
Up to Week 12
Title
High-Density Lipoprotein (HDL) Levels
Description
Measured from blood sample
Time Frame
Up to Week 12
Title
Low-Density Lipoprotein (LDL) Levels
Description
Measured from blood sample
Time Frame
Up to Week 12
Title
Triglycerides Levels
Description
Measured from blood sample
Time Frame
Up to Week 12
Title
High-sensitivity C-reactive protein (hs-CRP) Levels
Description
Measured from blood sample
Time Frame
Up to Week 12
Title
HbA1c Levels
Description
Measured from blood sample
Time Frame
Up to Week 12
Title
Heart Rate
Description
Measured from Fitbit
Time Frame
Up to Week 12
Title
Blood Pressure
Description
Measured from Fitbit
Time Frame
Up to Week 12
Title
Total Sleep Duration
Description
Measured from DREEM 2
Time Frame
Up to Week 12
Title
Slow Wave Sleep Duration
Description
Measured from DREEM 2
Time Frame
Up to Week 12
Title
Cortisol Levels
Description
Measured from Urine Sample
Time Frame
Up to Week 12
Title
Cortisone Levels
Description
Measured from Urine Sample
Time Frame
Up to Week 12
Title
Melatonin Levels
Description
Measured from Urine Sample
Time Frame
Up to Week 12
Title
Creatinine Levels
Description
Measured from Urine Sample
Time Frame
Up to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to perform mild exercise Able to wear DREEM 2 Headband Able to wear a Fitbit wrist watch Able to perform the Everlywell biomarker procedure Able to Understand and Speak English Able to operate a digital device like mobile phone, iPad, or computer Self-reported history of problems with cognitive impairment: memory, concentration, and processing information Only participants cognitively able and willing to provide consent will be included. Exclusion Criteria: Prohibited from or unable to perform mild exercise Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason Unable to speak or understand English Unable to use mobile device/smartphone technology Unable or unwilling to consent for any reason.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Azizi A Seixas, PhD
Phone
3052431301
Email
Azizi.seixas@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jesse Moore, MS
Phone
3052431301
Email
jxm6187@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azizi A Seixas, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Hospitals
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse Moore, MS
Phone
305-243-1301
Email
jxm6187@miami.edu
First Name & Middle Initial & Last Name & Degree
Azizi A Seixas, PhD
Phone
3052431301
Email
Azizi.seixas@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Azizi A Seixas, PhD
First Name & Middle Initial & Last Name & Degree
Arlener Turner, PhD
First Name & Middle Initial & Last Name & Degree
Alberto Ramos, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Combating Alzheimer's Through Sleep and Exercise

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